Communicating Multiple Disease Risks: A Translation of Risk Prediction Science
Sponsor
Washington University School of Medicine (Other)
Overall Status
Completed
CT.gov ID
NCT03255291
Collaborator
National Institutes of Health (NIH) (NIH), National Cancer Institute (NCI) (NIH)
554
1
6
18.2
30.4
Study Details
Study Description
Brief Summary
Epidemiology seeks to improve public health by identifying risk factors for cancer and other diseases and conveying that information to relevant audiences (e.g., physicians, the public). The audience is presumed to understand and use that information to make appropriate decisions about lifestyle behaviors and medical treatments. Yet, even though a single risk factor can affect the risk of multiple health outcomes, this information is seldom communicated to people in a way that optimizes their understanding of the importance of engaging in a single healthy behavior. Providing individuals with the ability to understand how a single behavior (obtaining sufficient physical activity) could affect their risk of developing multiple diseases could foster a more coherent and meaningful picture of the behavior's importance in reducing health risks, increase motivation and intentions to engage in the behavior, and over time improve public health.
The proposed study translates epidemiological data about five diseases that cause significant morbidity and mortality (i.e., colon cancer, breast cancer (women), heart disease, diabetes, and stroke) into a visual display that conveys individualized risk estimates in a comprehensible, meaningful, and useful way to diverse lay audiences.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Actual Enrollment
:
554 participants
Allocation:
Randomized
Intervention Model:
Factorial Assignment
Intervention Model Description:
Participants were randomly assigned by a computer algorithm to one of six intervention arms according to a 3 (risk display format: text, table, ladder) x 2 (imagery behavior: exercise, sleep) between-subjects factorial design. Although randomization was done at the same time and at the beginning of the study, participants received the risk display intervention first, then answered a survey containing two of the primary outcomes, then received the mental imagery intervention followed by another survey.Participants were randomly assigned by a computer algorithm to one of six intervention arms according to a 3 (risk display format: text, table, ladder) x 2 (imagery behavior: exercise, sleep) between-subjects factorial design. Although randomization was done at the same time and at the beginning of the study, participants received the risk display intervention first, then answered a survey containing two of the primary outcomes, then received the mental imagery intervention followed by another survey.
Masking:
Single (Investigator)
Masking Description:
The research staff will be blinded to participants' risk display format conditions, but they will be unblinded to mental imagery behavior condition
Primary Purpose:
Prevention
Official Title:
Communicating Multiple Disease Risks: A Translation of Risk Prediction Science
Actual Study Start Date
:
Jun 27, 2017
Actual Primary Completion Date
:
Jan 3, 2019
Actual Study Completion Date
:
Jan 3, 2019
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Risk Display Format:Risk Ladder:Imagery Behavior:Exercise With help from a research assistant, participants complete the Risk Assessment App. The App asks demographic & health questions. It then provides personalized risk estimates for participants' current activity level & how it would change with regular exercise. Participants take Baseline Survey 1. Participants listen to an audio recording that guides them through a mental imagery activity. They write down an exercise goal & are asked to practice the mental imagery twice a day for 3 weeks. Participants take Baseline Survey 2. Participants receive text messages reminding them to practice the mental imagery twice daily for 5 minutes each time (3 texts a week for 3 weeks). Participants take surveys via text at the end of each week for 4 weeks. 90 days post-baseline, participants complete a survey sent through the mail. Participants may be contacted for another survey 1 year later. |
Behavioral: Risk Assessment App
The App provides participants with personalized risk results for colon cancer, breast cancer (women), heart disease, diabetes, and stroke.
Other: Surveys
Assesses information comprehension, intentions, perceived risk and severity worry, self- efficacy, response efficacy, affect, race, education, age, numeracy, graph literacy, and exercise and sleep behaviors.
Behavioral: Audio Recording - Exercise
Participants imagine themselves improving exercise
Other: Text message reminders
-Reminders to practice mental imagery
Other: Text Message Survey
-Assesses exercise behavior, intentions, actions plans, self-efficacy, affect, imagery vividness, and practice.
|
| Experimental: Risk Display Format:Risk Ladder:Imagery Behavior:Sleep With help from a research assistant, participants complete the Risk Assessment App. The App asks demographic & health questions. It then provides personalized risk estimates for participants' current activity level & how it would change with regular exercise. Participants take Baseline Survey 1. Participants listen to an audio recording that guides them through a mental imagery activity. They write down a sleep goal & are asked to practice the mental imagery twice a day for 3 weeks. Participants take Baseline Survey 2. Participants receive text messages reminding them to practice the mental imagery twice daily for 5 minutes each time (3 texts a week for 3 weeks). Participants take surveys via text at the end of each week for 4 weeks. 90 days post-baseline, participants complete a survey sent through the mail. Participants may be contacted for another survey 1 year later. |
Behavioral: Risk Assessment App
The App provides participants with personalized risk results for colon cancer, breast cancer (women), heart disease, diabetes, and stroke.
Behavioral: Audio Recording - Sleep
-Participants imagine themselves improving sleep hygiene
Other: Surveys
Assesses information comprehension, intentions, perceived risk and severity worry, self- efficacy, response efficacy, affect, race, education, age, numeracy, graph literacy, and exercise and sleep behaviors.
Other: Text message reminders
-Reminders to practice mental imagery
Other: Text Message Survey
-Assesses exercise behavior, intentions, actions plans, self-efficacy, affect, imagery vividness, and practice.
|
| Experimental: Risk Display Format:Table:Imagery Behavior:Exercise With help from a research assistant, participants complete the Risk Assessment App. The App asks demographic & health questions. It then provides personalized risk estimates for participants' current activity level & how it would change with regular exercise. Participants take Baseline Survey 1. Participants listen to an audio recording that guides them through a mental imagery activity. They write down an exercise goal & are asked to practice the mental imagery twice a day for 3 weeks. Participants take Baseline Survey 2. Participants receive text messages reminding them to practice the mental imagery twice daily for 5 minutes each time (3 texts a week for 3 weeks). Participants take surveys via text at the end of each week for 4 weeks. 90 days post-baseline, participants complete a survey sent through the mail. Participants may be contacted for another survey 1 year later. |
Behavioral: Risk Assessment App
The App provides participants with personalized risk results for colon cancer, breast cancer (women), heart disease, diabetes, and stroke.
Other: Surveys
Assesses information comprehension, intentions, perceived risk and severity worry, self- efficacy, response efficacy, affect, race, education, age, numeracy, graph literacy, and exercise and sleep behaviors.
Behavioral: Audio Recording - Exercise
Participants imagine themselves improving exercise
Other: Text message reminders
-Reminders to practice mental imagery
Other: Text Message Survey
-Assesses exercise behavior, intentions, actions plans, self-efficacy, affect, imagery vividness, and practice.
|
| Experimental: Risk Display Format:Table: Imagery Behavior:Sleep With help from a research assistant, participants complete the Risk Assessment App. The App asks demographic & health questions. It then provides personalized risk estimates for participants' current activity level & how it would change with regular exercise. Participants take Baseline Survey 1. Participants listen to an audio recording that guides them through a mental imagery activity. They write down a sleep goal & are asked to practice the mental imagery twice a day for 3 weeks. Participants take Baseline Survey 2. Participants receive text messages reminding them to practice the mental imagery twice daily for 5 minutes each time (3 texts a week for 3 weeks). Participants take surveys via text at the end of each week for 4 weeks. 90 days post-baseline, participants complete a survey sent through the mail. Participants may be contacted for another survey 1 year later. |
Behavioral: Risk Assessment App
The App provides participants with personalized risk results for colon cancer, breast cancer (women), heart disease, diabetes, and stroke.
Behavioral: Audio Recording - Sleep
-Participants imagine themselves improving sleep hygiene
Other: Surveys
Assesses information comprehension, intentions, perceived risk and severity worry, self- efficacy, response efficacy, affect, race, education, age, numeracy, graph literacy, and exercise and sleep behaviors.
Other: Text message reminders
-Reminders to practice mental imagery
Other: Text Message Survey
-Assesses exercise behavior, intentions, actions plans, self-efficacy, affect, imagery vividness, and practice.
|
| Experimental: Risk Display Format:Text:Imagery Behavior:Exercise With help from a research assistant, participants complete the Risk Assessment App. The App asks demographic & health questions. It then provides personalized risk estimates for participants' current activity level & how it would change with regular exercise. Participants take Baseline Survey 1. Participants listen to an audio recording that guides them through a mental imagery activity. They write down an exercise goal & are asked to practice the mental imagery twice a day for 3 weeks. Participants take Baseline Survey 2. Participants receive text messages reminding them to practice the mental imagery twice daily for 5 minutes each time (3 texts a week for 3 weeks). Participants take surveys via text at the end of each week for 4 weeks. 90 days post-baseline, participants complete a survey sent through the mail. Participants may be contacted for another survey 1 year later. |
Behavioral: Risk Assessment App
The App provides participants with personalized risk results for colon cancer, breast cancer (women), heart disease, diabetes, and stroke.
Other: Surveys
Assesses information comprehension, intentions, perceived risk and severity worry, self- efficacy, response efficacy, affect, race, education, age, numeracy, graph literacy, and exercise and sleep behaviors.
Behavioral: Audio Recording - Exercise
Participants imagine themselves improving exercise
Other: Text message reminders
-Reminders to practice mental imagery
Other: Text Message Survey
-Assesses exercise behavior, intentions, actions plans, self-efficacy, affect, imagery vividness, and practice.
|
| Experimental: Risk Display Format:Text:Imagery Behavior:Sleep With help from a research assistant, participants complete the Risk Assessment App. The App asks demographic & health questions. It then provides personalized risk estimates for participants' current activity level & how it would change with regular exercise. Participants take Baseline Survey 1. Participants listen to an audio recording that guides them through a mental imagery activity. They write down a sleep goal & are asked to practice the mental imagery twice a day for 3 weeks. Participants take Baseline Survey 2. Participants receive text messages reminding them to practice the mental imagery twice daily for 5 minutes each time (3 texts a week for 3 weeks). Participants take surveys via text at the end of each week for 4 weeks. 90 days post-baseline, participants complete a survey sent through the mail. Participants may be contacted for another survey 1 year later. |
Behavioral: Risk Assessment App
The App provides participants with personalized risk results for colon cancer, breast cancer (women), heart disease, diabetes, and stroke.
Behavioral: Audio Recording - Sleep
-Participants imagine themselves improving sleep hygiene
Other: Surveys
Assesses information comprehension, intentions, perceived risk and severity worry, self- efficacy, response efficacy, affect, race, education, age, numeracy, graph literacy, and exercise and sleep behaviors.
Other: Text message reminders
-Reminders to practice mental imagery
Other: Text Message Survey
-Assesses exercise behavior, intentions, actions plans, self-efficacy, affect, imagery vividness, and practice.
|
Outcome Measures
Primary Outcome Measures
- Change From Baseline to 90-day Follow-up in Self Reported Weekly Minutes of Exercise [Baseline and up to 90 days]
- Difference in Gist Comprehension of Risk Information by Risk Display Format [Baseline]
Risk display format = risk ladder, table, or text Gist comprehension of risk information: being able to extract the bottom-line meaning of information provided by the website (e.g., if exercising decreased heath risk) Measured by the sum of (4) questions coded as correctly comprehending risk information (1 point) or incorrectly comprehending risk information (0 points), with a total score range of 0=low comprehension to 4=high comprehension. Higher comprehension is considered a better outcome. All comprehension questions have an additional "don't know" option, which is counted as incorrect. To limit participant burden, the investigators assessed comprehension for diabetes only, instead of all diseases as planned. Comprehension will not be assessed for people who report a history of diabetes because they are not given risk information.
- Difference in Verbatim Comprehension of Risk Information by Risk Communication Strategy [Baseline]
Risk communication strategy = risk ladder, table, or text Verbatim comprehension of risk information: being able to recall the exact information specific to diabetes risk and hours of recommended weekly physical activity Measured by the sum of (3) questions coded as correctly comprehending information (1 point) or incorrectly comprehending information (0 points), with a total score range of 0=low comprehension to 3=high comprehension. Higher comprehension is considered a better outcome. All comprehension questions have an additional "don't know" option, which is counted as incorrect. To limit participant burden, the investigators assessed comprehension for diabetes only, instead of all diseases as planned. Comprehension will not be assessed for people who report a history of diabetes because they are not given risk information.
- Difference in Self-reported Intentions to Engage in Physical Activity by Risk Display Format [Baseline]
Risk display format = risk ladder, table, or text Self-reported physical activity intentions is defined as intentions to engage in physical activity in the next 3 months Measured as an average of three variables, each measured on a 5 point Likert Scale (range: 1=lower intentions to 5=higher intentions) Higher intentions are considered a better outcome
Secondary Outcome Measures
- Effect of the Intervention on Physical Activity Levels as Measured by Maintenance Self-efficacy [90 days]
Maintenance Self-efficacy is defined as being sure one can engage in physical activity even when it is hard Measured on a 4 point Likert Scale (range: 1=lower Maintenance Self-efficacy to 4=higher Maintenance Self-efficacy) Higher maintenance self-efficacy is considered a better outcome Note: to limit participant burden, the investigators used a single item instead of averaging across multiple items
- Effect of the Intervention on Physical Activity Levels as Measured by Recovery Self-efficacy [90 days]
Recovery Self-efficacy is defined as being sure one can re-engage in physical activity after putting it off Measured on a 4 point Likert Scale (range: 1=lower recovery Self-efficacy to 4=higher recovery Self-efficacy) Higher recovery self-efficacy is considered a better outcome Note: to limit participant burden, the investigators used a single item instead of averaging across multiple items
- Effect of the Intervention on Physical Activity Levels as Measured by Affective Attitudes to Exercise - Enjoying Behavior [90 days]
Affective Attitudes to Exercise - Enjoying Behavior is defined as thinking getting regular exercise is enjoyable Measured on a 4 point Likert Scale (range: 1=lower Affective Attitudes to Exercise to 4=higher Affective Attitudes to Exercise) Higher Affective Attitudes to Exercise - Enjoying Behavior is considered a better outcome Note: to limit participant burden, the investigators used a single item instead of averaging across multiple items
- Effect of the Intervention on Physical Activity Levels as Measured by Affective Attitudes to Exercise - Thinking Behavior is Unpleasant [90 days]
Affective Attitudes to Exercise - Thinking Behavior is Unpleasant is defined as not thinking getting regular exercise is unpleasant Measured on a 4 point Likert Scale (range: 1=lower Affective Attitudes to Exercise to 4=higher Affective Attitudes to Exercise) Higher Affective Attitudes to Exercise - Thinking Behavior is Unpleasant is considered a better outcome Note: to limit participant burden, the investigators used a single item instead of averaging across multiple items
- Effect of the Intervention on Physical Activity Levels as Measured by Perceived Vividness of Self-regulatory Imagery [90 days]
Perceived Vividness of Self-regulatory Imagery is defined as having clear and vivid images of steps towards getting physical activity Measured as an average of two variables measured on a 4 point Likert Scale (range: 1=lower Perceived Vividness of Self-regulatory Imagery to 4=higher Perceived Vividness of Self-regulatory Imagery) Higher Perceived Vividness of Self-regulatory Imagery is considered a better outcome Note: to limit participant burden, the investigators used a single item instead of averaging across multiple items
- Effect of the Intervention on Physical Activity Levels as Measured by Action Planning [90 days]
Action planning is defined as having a detailed plan about getting adequate physical activity Measured as an average of three variables measured on a 4 point Likert Scale (range: 1=lower action planning to 4=higher action planning) Higher action planning is considered a better outcome Note: to limit participant burden, the investigators used a single item instead of averaging across multiple items
- Effect of the Intervention on Physical Activity Levels as Measured by Coping Planning [90 days]
Coping planning is defined as having a detailed plan of solving problems that may prevent getting adequate physical activity Measured on a 4 point Likert Scale (range: 1=lower Coping Planning to 4=higher Coping Planning) Higher coping planning is considered a better outcome Note: to limit participant burden, the investigators used a single item instead of averaging across multiple items
- Effect of the Intervention on Physical Activity Levels as Measured by Action Self-efficacy [90 days]
Action self-efficacy is defined as having the confidence to engage in physical activity Measured on a 4 point Likert Scale (range: 1=lower Action Self-efficacy to 4=higher Action Self-efficacy) Higher Action Self-efficacy is considered a better outcome Note: to limit participant burden, the investigators used a single item instead of averaging across multiple items
Eligibility Criteria
Criteria
Ages Eligible for Study:
30 Years
to 64 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
-
30-64 years of age
-
Less than (3) relevant comorbidities (diabetes, heart disease, stroke, and cancer, where cancer counts as (2) comorbidities for women but (1) for men)
-
Having a SMS capable mobile phone that is not shared with anyone else
Exclusion Criteria:
-
Not meeting national guidelines for aerobic physical activity (i.e., at least 150 minutes per week of moderate intensity aerobic physical activity)
-
Participants from HRPO# 201501028 will be ineligible for this study
-
Uses text messaging less than once per month
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Washington University School of Medicine | Saint Louis | Missouri | United States | 63110 |
Sponsors and Collaborators
- Washington University School of Medicine
- National Institutes of Health (NIH)
- National Cancer Institute (NCI)
Investigators
- Principal Investigator: Erika Waters, MPH, Ph.D., Washington University School of Medicine
Study Documents (Full-Text)
More Information
Additional Information:
Publications
None provided.Responsible Party:
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT03255291
Other Study ID Numbers:
- 201706063
- R01CA190391
First Posted:
Aug 21, 2017
Last Update Posted:
Jan 18, 2020
Last Verified:
Jan 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Risk Display Format:Risk Ladder:Imagery Behavior:Exercise | Risk Display Format:Risk Ladder:Imagery Behavior:Sleep | Risk Display Format:Table:Imagery Behavior:Exercise | Risk Display Format:Table: Imagery Behavior:Sleep | Risk Display Format:Text:Imagery Behavior:Exercise | Risk Display Format:Text:Imagery Behavior:Sleep |
|---|---|---|---|---|---|---|
| Arm/Group Description | With help from a research assistant, participants complete the Risk Assessment App. The App asks demographic & health questions. It then provides personalized risk estimates for participants' current activity level & how it would change with regular exercise. Participants take Baseline Survey 1. Participants listen to an audio recording that guides them through a mental imagery activity. They write down an exercise goal & are asked to practice the mental imagery twice a day for 3 weeks. Participants take Baseline Survey 2. Participants receive text messages reminding them to practice the mental imagery twice daily for 5 minutes each time (3 texts a week for 3 weeks). Participants take surveys via text at the end of each week for 4 weeks. 90 days post-baseline, participants complete a survey sent through the mail. Participants may be contacted for another survey 1 year later. | With help from a research assistant, participants complete the Risk Assessment App. The App asks demographic & health questions. It then provides personalized risk estimates for participants' current activity level & how it would change with regular exercise. Participants take Baseline Survey 1. Participants listen to an audio recording that guides them through a mental imagery activity. They write down a sleep goal & are asked to practice the mental imagery twice a day for 3 weeks. Participants take Baseline Survey 2. Participants receive text messages reminding them to practice the mental imagery twice daily for 5 minutes each time (3 texts a week for 3 weeks). Participants take surveys via text at the end of each week for 4 weeks. 90 days post-baseline, participants complete a survey sent through the mail. Participants may be contacted for another survey 1 year later. | With help from a research assistant, participants complete the Risk Assessment App. The App asks demographic & health questions. It then provides personalized risk estimates for participants' current activity level & how it would change with regular exercise. Participants take Baseline Survey 1. Participants listen to an audio recording that guides them through a mental imagery activity. They write down an exercise goal & are asked to practice the mental imagery twice a day for 3 weeks. Participants take Baseline Survey 2. Participants receive text messages reminding them to practice the mental imagery twice daily for 5 minutes each time (3 texts a week for 3 weeks). Participants take surveys via text at the end of each week for 4 weeks. 90 days post-baseline, participants complete a survey sent through the mail. Participants may be contacted for another survey 1 year later. | With help from a research assistant, participants complete the Risk Assessment App. The App asks demographic & health questions. It then provides personalized risk estimates for participants' current activity level & how it would change with regular exercise. Participants take Baseline Survey 1. Participants listen to an audio recording that guides them through a mental imagery activity. They write down a sleep goal & are asked to practice the mental imagery twice a day for 3 weeks. Participants take Baseline Survey 2. Participants receive text messages reminding them to practice the mental imagery twice daily for 5 minutes each time (3 texts a week for 3 weeks). Participants take surveys via text at the end of each week for 4 weeks. 90 days post-baseline, participants complete a survey sent through the mail. Participants may be contacted for another survey 1 year later. | With help from a research assistant, participants complete the Risk Assessment App. The App asks demographic & health questions. It then provides personalized risk estimates for participants' current activity level & how it would change with regular exercise. Participants take Baseline Survey 1. Participants listen to an audio recording that guides them through a mental imagery activity. They write down an exercise goal & are asked to practice the mental imagery twice a day for 3 weeks. Participants take Baseline Survey 2. Participants receive text messages reminding them to practice the mental imagery twice daily for 5 minutes each time (3 texts a week for 3 weeks). Participants take surveys via text at the end of each week for 4 weeks. 90 days post-baseline, participants complete a survey sent through the mail. Participants may be contacted for another survey 1 year later. | With help from a research assistant, participants complete the Risk Assessment App. The App asks demographic & health questions. It then provides personalized risk estimates for participants' current activity level & how it would change with regular exercise. Participants take Baseline Survey 1. Participants listen to an audio recording that guides them through a mental imagery activity. They write down a sleep goal & are asked to practice the mental imagery twice a day for 3 weeks. Participants take Baseline Survey 2. Participants receive text messages reminding them to practice the mental imagery twice daily for 5 minutes each time (3 texts a week for 3 weeks). Participants take surveys via text at the end of each week for 4 weeks. 90 days post-baseline, participants complete a survey sent through the mail. Participants may be contacted for another survey 1 year later. |
| Period Title: Overall Study | ||||||
| STARTED | 93 | 90 | 91 | 90 | 95 | 95 |
| COMPLETED | 80 | 78 | 85 | 84 | 88 | 85 |
| NOT COMPLETED | 13 | 12 | 6 | 6 | 7 | 10 |
Baseline Characteristics
| Arm/Group Title | Risk Display Format:Risk Ladder:Imagery Behavior:Exercise | Risk Display Format:Risk Ladder:Imagery Behavior:Sleep | Risk Display Format:Table:Imagery Behavior:Exercise | Risk Display Format:Table:Imagery Behavior:Sleep | Risk Display Format:Text:Imagery Behavior:Exercise | Risk Display Format:Text:Imagery Behavior:Sleep | Total |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | With help from a research assistant, participants complete the Risk Assessment App. The App asks demographic & health questions. It then provides personalized risk estimates for participants' current activity level & how it would change with regular exercise. Participants take Baseline Survey 1. Participants listen to an audio recording that guides them through a mental imagery activity. They write down an exercise goal & are asked to practice the mental imagery twice a day for 3 weeks. Participants take Baseline Survey 2. Participants receive text messages reminding them to practice the mental imagery twice daily for 5 minutes each time (3 texts a week for 3 weeks). Participants take surveys via text at the end of each week for 4 weeks. 90 days post-baseline, participants complete a survey sent through the mail. Participants may be contacted for another survey 1 year later. | With help from a research assistant, participants complete the Risk Assessment App. The App asks demographic & health questions. It then provides personalized risk estimates for participants' current activity level & how it would change with regular exercise. Participants take Baseline Survey 1. Participants listen to an audio recording that guides them through a mental imagery activity. They write down a sleep goal & are asked to practice the mental imagery twice a day for 3 weeks. Participants take Baseline Survey 2. Participants receive text messages reminding them to practice the mental imagery twice daily for 5 minutes each time (3 texts a week for 3 weeks). Participants take surveys via text at the end of each week for 4 weeks. 90 days post-baseline, participants complete a survey sent through the mail. Participants may be contacted for another survey 1 year later. | With help from a research assistant, participants complete the Risk Assessment App. The App asks demographic & health questions. It then provides personalized risk estimates for participants' current activity level & how it would change with regular exercise. Participants take Baseline Survey 1. Participants listen to an audio recording that guides them through a mental imagery activity. They write down an exercise goal & are asked to practice the mental imagery twice a day for 3 weeks. Participants take Baseline Survey 2. Participants receive text messages reminding them to practice the mental imagery twice daily for 5 minutes each time (3 texts a week for 3 weeks). Participants take surveys via text at the end of each week for 4 weeks. 90 days post-baseline, participants complete a survey sent through the mail. Participants may be contacted for another survey 1 year later. | With help from a research assistant, participants complete the Risk Assessment App. The App asks demographic & health questions. It then provides personalized risk estimates for participants' current activity level & how it would change with regular exercise. Participants take Baseline Survey 1. Participants listen to an audio recording that guides them through a mental imagery activity. They write down a sleep goal & are asked to practice the mental imagery twice a day for 3 weeks. Participants take Baseline Survey 2. Participants receive text messages reminding them to practice the mental imagery twice daily for 5 minutes each time (3 texts a week for 3 weeks). Participants take surveys via text at the end of each week for 4 weeks. 90 days post-baseline, participants complete a survey sent through the mail. Participants may be contacted for another survey 1 year later. | With help from a research assistant, participants complete the Risk Assessment App. The App asks demographic & health questions. It then provides personalized risk estimates for participants' current activity level & how it would change with regular exercise. Participants take Baseline Survey 1. Participants listen to an audio recording that guides them through a mental imagery activity. They write down an exercise goal & are asked to practice the mental imagery twice a day for 3 weeks. Participants take Baseline Survey 2. Participants receive text messages reminding them to practice the mental imagery twice daily for 5 minutes each time (3 texts a week for 3 weeks). Participants take surveys via text at the end of each week for 4 weeks. 90 days post-baseline, participants complete a survey sent through the mail. Participants may be contacted for another survey 1 year later. | With help from a research assistant, participants complete the Risk Assessment App. The App asks demographic & health questions. It then provides personalized risk estimates for participants' current activity level & how it would change with regular exercise. Participants take Baseline Survey 1. Participants listen to an audio recording that guides them through a mental imagery activity. They write down a sleep goal & are asked to practice the mental imagery twice a day for 3 weeks. Participants take Baseline Survey 2. Participants receive text messages reminding them to practice the mental imagery twice daily for 5 minutes each time (3 texts a week for 3 weeks). Participants take surveys via text at the end of each week for 4 weeks. 90 days post-baseline, participants complete a survey sent through the mail. Participants may be contacted for another survey 1 year later. | Total of all reporting groups |
| Overall Participants | 80 | 78 | 85 | 84 | 88 | 85 | 500 |
| Age (years) [Mean (Standard Deviation) ] | |||||||
| Mean (Standard Deviation) [years] |
47.2
(9.8)
|
47.3
(8.7)
|
50.3
(9.9)
|
49.8
(9.9)
|
46.8
(10.7)
|
47.2
(10.5)
|
48.1
(10.0)
|
| Sex: Female, Male (Count of Participants) | |||||||
| Female |
63
78.8%
|
67
85.9%
|
68
80%
|
67
79.8%
|
69
78.4%
|
73
85.9%
|
407
81.4%
|
| Male |
17
21.3%
|
11
14.1%
|
17
20%
|
17
20.2%
|
19
21.6%
|
12
14.1%
|
93
18.6%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |||||||
| Hispanic or Latino |
4
5%
|
1
1.3%
|
1
1.2%
|
5
6%
|
4
4.5%
|
2
2.4%
|
17
3.4%
|
| Not Hispanic or Latino |
76
95%
|
77
98.7%
|
84
98.8%
|
79
94%
|
84
95.5%
|
83
97.6%
|
483
96.6%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Race/Ethnicity, Customized (Count of Participants) | |||||||
| American Indian/Alaskan Native |
1
1.3%
|
0
0%
|
1
1.2%
|
0
0%
|
0
0%
|
0
0%
|
2
0.4%
|
| Asian/Pacific Islander |
1
1.3%
|
0
0%
|
2
2.4%
|
0
0%
|
1
1.1%
|
2
2.4%
|
6
1.2%
|
| Black/African American |
27
33.8%
|
35
44.9%
|
26
30.6%
|
37
44%
|
37
42%
|
23
27.1%
|
185
37%
|
| White/Caucasian |
49
61.3%
|
43
55.1%
|
50
58.8%
|
40
47.6%
|
46
52.3%
|
56
65.9%
|
284
56.8%
|
| Multiracial/Other |
2
2.5%
|
0
0%
|
6
7.1%
|
7
8.3%
|
4
4.5%
|
4
4.7%
|
23
4.6%
|
| Region of Enrollment (participants) [Number] | |||||||
| United States |
80
100%
|
78
100%
|
85
100%
|
84
100%
|
88
100%
|
85
100%
|
500
100%
|
| Vocational-technical training or less (Count of Participants) | |||||||
| Count of Participants [Participants] |
20
25%
|
20
25.6%
|
14
16.5%
|
14
16.7%
|
15
17%
|
14
16.5%
|
97
19.4%
|
| Body mass index (BMI) - Obese (Count of Participants) | |||||||
| Count of Participants [Participants] |
38
47.5%
|
32
41%
|
46
54.1%
|
52
61.9%
|
48
54.5%
|
42
49.4%
|
258
51.6%
|
| Body mass index (BMI) - Overweight (Count of Participants) | |||||||
| Count of Participants [Participants] |
21
26.3%
|
23
29.5%
|
19
22.4%
|
15
17.9%
|
24
27.3%
|
25
29.4%
|
127
25.4%
|
| 1+ comorbidity (Count of Participants) | |||||||
| Count of Participants [Participants] |
14
17.5%
|
6
7.7%
|
21
24.7%
|
17
20.2%
|
19
21.6%
|
15
17.6%
|
92
18.4%
|
| Baseline Exercise (minutes per week in last 7 days) (minutes) [Mean (Standard Deviation) ] | |||||||
| Mean (Standard Deviation) [minutes] |
56.7
(44.8)
|
56.9
(45.1)
|
53.9
(47.4)
|
50.2
(45.4)
|
41.3
(41.1)
|
56.0
(43.4)
|
52.3
(44.7)
|
| Self-Reported Health (units on a scale) [Mean (Standard Deviation) ] | |||||||
| Mean (Standard Deviation) [units on a scale] |
3.0
(1.0)
|
3.1
(0.9)
|
3.0
(1.0)
|
3.1
(0.9)
|
3.0
(0.9)
|
3.0
(0.9)
|
3.0
(0.9)
|
| Numeracy (units on a scale) [Mean (Standard Deviation) ] | |||||||
| Mean (Standard Deviation) [units on a scale] |
1.6
(1.0)
|
1.3
(0.9)
|
1.7
(1.0)
|
1.5
(1.1)
|
1.5
(1.1)
|
1.6
(1.0)
|
1.5
(1.0)
|
| Graph literacy (units on a scale) [Mean (Standard Deviation) ] | |||||||
| Mean (Standard Deviation) [units on a scale] |
2.5
(1.1)
|
2.1
(1.2)
|
2.2
(1.2)
|
2.3
(1.1)
|
2.2
(1.2)
|
2.6
(1.0)
|
2.3
(1.1)
|
Outcome Measures
| Title | Change From Baseline to 90-day Follow-up in Self Reported Weekly Minutes of Exercise |
|---|---|
| Description | |
| Time Frame | Baseline and up to 90 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| Additional participants who did not complete the 90 day follow up survey or completed the survey over 8 weeks late, were inattentive responders, had text messaging errors, or were considered an outlier (>99th percentile) in change in minutes of exercise per week were excluded for analysis |
| Arm/Group Title | Risk Display Format:Risk Ladder:Imagery Behavior:Exercise | Risk Display Format:Risk Ladder:Imagery Behavior:Sleep | Risk Display Format:Table:Imagery Behavior:Exercise | Risk Display Format:Table: Imagery Behavior:Sleep | Risk Display Format:Text:Imagery Behavior:Exercise | Risk Display Format:Text:Imagery Behavior:Sleep |
|---|---|---|---|---|---|---|
| Arm/Group Description | With help from a research assistant, participants complete the Risk Assessment App. The App asks demographic & health questions. It then provides personalized risk estimates for participants' current activity level & how it would change with regular exercise. Participants take Baseline Survey 1. Participants listen to an audio recording that guides them through a mental imagery activity. They write down an exercise goal & are asked to practice the mental imagery twice a day for 3 weeks. Participants take Baseline Survey 2. Participants receive text messages reminding them to practice the mental imagery twice daily for 5 minutes each time (3 texts a week for 3 weeks). Participants take surveys via text at the end of each week for 4 weeks. 90 days post-baseline, participants complete a survey sent through the mail. Participants may be contacted for another survey 1 year later. | With help from a research assistant, participants complete the Risk Assessment App. The App asks demographic & health questions. It then provides personalized risk estimates for participants' current activity level & how it would change with regular exercise. Participants take Baseline Survey 1. Participants listen to an audio recording that guides them through a mental imagery activity. They write down a sleep goal & are asked to practice the mental imagery twice a day for 3 weeks. Participants take Baseline Survey 2. Participants receive text messages reminding them to practice the mental imagery twice daily for 5 minutes each time (3 texts a week for 3 weeks). Participants take surveys via text at the end of each week for 4 weeks. 90 days post-baseline, participants complete a survey sent through the mail. Participants may be contacted for another survey 1 year later. | With help from a research assistant, participants complete the Risk Assessment App. The App asks demographic & health questions. It then provides personalized risk estimates for participants' current activity level & how it would change with regular exercise. Participants take Baseline Survey 1. Participants listen to an audio recording that guides them through a mental imagery activity. They write down an exercise goal & are asked to practice the mental imagery twice a day for 3 weeks. Participants take Baseline Survey 2. Participants receive text messages reminding them to practice the mental imagery twice daily for 5 minutes each time (3 texts a week for 3 weeks). Participants take surveys via text at the end of each week for 4 weeks. 90 days post-baseline, participants complete a survey sent through the mail. Participants may be contacted for another survey 1 year later. | With help from a research assistant, participants complete the Risk Assessment App. The App asks demographic & health questions. It then provides personalized risk estimates for participants' current activity level & how it would change with regular exercise. Participants take Baseline Survey 1. Participants listen to an audio recording that guides them through a mental imagery activity. They write down a sleep goal & are asked to practice the mental imagery twice a day for 3 weeks. Participants take Baseline Survey 2. Participants receive text messages reminding them to practice the mental imagery twice daily for 5 minutes each time (3 texts a week for 3 weeks). Participants take surveys via text at the end of each week for 4 weeks. 90 days post-baseline, participants complete a survey sent through the mail. Participants may be contacted for another survey 1 year later. | With help from a research assistant, participants complete the Risk Assessment App. The App asks demographic & health questions. It then provides personalized risk estimates for participants' current activity level & how it would change with regular exercise. Participants take Baseline Survey 1. Participants listen to an audio recording that guides them through a mental imagery activity. They write down an exercise goal & are asked to practice the mental imagery twice a day for 3 weeks. Participants take Baseline Survey 2. Participants receive text messages reminding them to practice the mental imagery twice daily for 5 minutes each time (3 texts a week for 3 weeks). Participants take surveys via text at the end of each week for 4 weeks. 90 days post-baseline, participants complete a survey sent through the mail. Participants may be contacted for another survey 1 year later. | With help from a research assistant, participants complete the Risk Assessment App. The App asks demographic & health questions. It then provides personalized risk estimates for participants' current activity level & how it would change with regular exercise. Participants take Baseline Survey 1. Participants listen to an audio recording that guides them through a mental imagery activity. They write down a sleep goal & are asked to practice the mental imagery twice a day for 3 weeks. Participants take Baseline Survey 2. Participants receive text messages reminding them to practice the mental imagery twice daily for 5 minutes each time (3 texts a week for 3 weeks). Participants take surveys via text at the end of each week for 4 weeks. 90 days post-baseline, participants complete a survey sent through the mail. Participants may be contacted for another survey 1 year later. |
| Measure Participants | 70 | 66 | 72 | 67 | 73 | 72 |
| Least Squares Mean (Standard Error) [minutes] |
92.2
(12.7)
|
37.5
(13.4)
|
63.1
(12.4)
|
60.0
(12.9)
|
50.1
(12.5)
|
49.3
(13.0)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Risk Display Format:Risk Ladder:Imagery Behavior:Sleep, Risk Display Format:Table: Imagery Behavior:Sleep, Risk Display Format:Text:Imagery Behavior:Sleep |
|---|---|---|
| Comments | The investigators tested whether weekly minutes of exercise at 90 day follow-up was higher in the exercise mental imagery condition than in the sleep mental imagery condition | |
| Type of Statistical Test | Superiority | |
| Comments | A Dunnett adjustment was used to adjust for multiple comparisons | |
| Statistical Test of Hypothesis | p-Value | 0.0288 |
| Comments | ||
| Method | ANCOVA | |
| Comments | Covariates: sex, race, age, education, health literacy, season, risk display problem, acceptability, self-reported health, and baseline exercise. | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Risk Display Format:Text:Imagery Behavior:Exercise, Risk Display Format:Text:Imagery Behavior:Sleep |
|---|---|---|
| Comments | -The investigators tested whether weekly minutes of exercise differed among the three risk display formats: risk ladder, table, and alphanumeric text. | |
| Type of Statistical Test | Superiority | |
| Comments | -A Dunnett adjustment was used to adjust for multiple comparisons | |
| Statistical Test of Hypothesis | p-Value | 0.3329 |
| Comments | ||
| Method | ANCOVA | |
| Comments | Covariates: sex, race, age, education, health literacy, season, risk display problem, acceptability, self-reported health, and baseline exercise. | |
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Risk Display Format:Text:Imagery Behavior:Sleep |
|---|---|---|
| Comments | -The investigators tested whether weekly minutes of exercise was influenced by an interaction between risk display format and mental imagery behavior | |
| Type of Statistical Test | Superiority | |
| Comments | -A Dunnett adjustment was used to adjust for multiple comparisons | |
| Statistical Test of Hypothesis | p-Value | 0.0215 |
| Comments | ||
| Method | ANCOVA | |
| Comments | Covariates: sex, race, age, education, health literacy, season, risk display problem, acceptability, self-reported health, and baseline exercise. | |
| Title | Difference in Gist Comprehension of Risk Information by Risk Display Format |
|---|---|
| Description | Risk display format = risk ladder, table, or text Gist comprehension of risk information: being able to extract the bottom-line meaning of information provided by the website (e.g., if exercising decreased heath risk) Measured by the sum of (4) questions coded as correctly comprehending risk information (1 point) or incorrectly comprehending risk information (0 points), with a total score range of 0=low comprehension to 4=high comprehension. Higher comprehension is considered a better outcome. All comprehension questions have an additional "don't know" option, which is counted as incorrect. To limit participant burden, the investigators assessed comprehension for diabetes only, instead of all diseases as planned. Comprehension will not be assessed for people who report a history of diabetes because they are not given risk information. |
| Time Frame | Baseline |
Outcome Measure Data
| Analysis Population Description |
|---|
| This study was designed as a 3X2 factorial design & only the risk display format intervention (risk ladder, table, or text) was looked at for this outcome, as participants had not yet received the mental imagery intervention, thus it could not affect this outcome. |
| Arm/Group Title | Risk Display Format: Risk Ladder | Risk Display Format: Table | Risk Display Format: Text |
|---|---|---|---|
| Arm/Group Description | -The personalized risk estimates were shown to participants as a risk ladder. | -The personalized risk estimates were shown to participants as a table. | -The personalized risk estimates were shown to participants as text. |
| Measure Participants | 125 | 120 | 127 |
| Least Squares Mean (Standard Error) [score on a scale] |
3.6
(0.1)
|
3.4
(0.1)
|
3.2
(0.1)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Risk Display Format:Risk Ladder:Imagery Behavior:Exercise, Risk Display Format:Risk Ladder:Imagery Behavior:Sleep, Risk Display Format:Table:Imagery Behavior:Exercise |
|---|---|---|
| Comments | -This study was designed as a 3X2 factorial design and only the risk display format intervention (risk ladder, table, or text) was looked at for this outcome, as participants had not yet received the mental imagery intervention, thus it could not affect this outcome. A Dunnett adjustment was used to adjust for multiple comparisons. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0333 |
| Comments | -A Dunnett adjustment was used to adjust for multiple comparisons | |
| Method | ANCOVA | |
| Comments | Covariates were sex, race, age, education, numeracy, and graph literacy. | |
| Title | Difference in Verbatim Comprehension of Risk Information by Risk Communication Strategy |
|---|---|
| Description | Risk communication strategy = risk ladder, table, or text Verbatim comprehension of risk information: being able to recall the exact information specific to diabetes risk and hours of recommended weekly physical activity Measured by the sum of (3) questions coded as correctly comprehending information (1 point) or incorrectly comprehending information (0 points), with a total score range of 0=low comprehension to 3=high comprehension. Higher comprehension is considered a better outcome. All comprehension questions have an additional "don't know" option, which is counted as incorrect. To limit participant burden, the investigators assessed comprehension for diabetes only, instead of all diseases as planned. Comprehension will not be assessed for people who report a history of diabetes because they are not given risk information. |
| Time Frame | Baseline |
Outcome Measure Data
| Analysis Population Description |
|---|
| This study was designed as a 3X2 factorial design & only the risk display format intervention (risk ladder, table, or text) was looked at for this outcome, as participants had not yet received the mental imagery intervention, thus it could not affect this outcome. |
| Arm/Group Title | Risk Display Format: Risk Ladder | Risk Display Format: Table | Risk Display Format: Text |
|---|---|---|---|
| Arm/Group Description | -The personalized risk estimates were shown to participants as a risk ladder. | -The personalized risk estimates were shown to participants as a table. | -The personalized risk estimates were shown to participants as text. |
| Measure Participants | 125 | 120 | 127 |
| Least Squares Mean (Standard Error) [score on a scale] |
1.6
(0.1)
|
1.6
(0.1)
|
1.5
(0.1)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Risk Display Format:Risk Ladder:Imagery Behavior:Exercise, Risk Display Format:Risk Ladder:Imagery Behavior:Sleep, Risk Display Format:Table:Imagery Behavior:Exercise |
|---|---|---|
| Comments | This study was designed as a 3X2 factorial design & only the risk display format intervention (risk ladder, table, or text) was looked at for this outcome, as participants had not yet received the mental imagery intervention, thus it could not affect this outcome. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.4946 |
| Comments | -A Dunnett adjustment was used to adjust for multiple comparisons | |
| Method | ANCOVA | |
| Comments | Covariates were sex, race, age, education, numeracy, and graph literacy. | |
| Title | Difference in Self-reported Intentions to Engage in Physical Activity by Risk Display Format |
|---|---|
| Description | Risk display format = risk ladder, table, or text Self-reported physical activity intentions is defined as intentions to engage in physical activity in the next 3 months Measured as an average of three variables, each measured on a 5 point Likert Scale (range: 1=lower intentions to 5=higher intentions) Higher intentions are considered a better outcome |
| Time Frame | Baseline |
Outcome Measure Data
| Analysis Population Description |
|---|
| This study was designed as a 3X2 factorial design & only the risk display format intervention (risk ladder, table, or text) was looked at for this outcome, as participants had not yet received the mental imagery intervention, thus it could not affect this outcome. |
| Arm/Group Title | Risk Display Format: Risk Ladder | Risk Display Format: Table | Risk Display Format: Text |
|---|---|---|---|
| Arm/Group Description | -The personalized risk estimates were shown to participants as a risk ladder. | -The personalized risk estimates were shown to participants as a table. | -The personalized risk estimates were shown to participants as text. |
| Measure Participants | 125 | 120 | 127 |
| Least Squares Mean (Standard Error) [score on a scale] |
3.9
(0.1)
|
4.0
(0.1)
|
3.8
(0.1)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Risk Display Format:Risk Ladder:Imagery Behavior:Exercise, Risk Display Format:Risk Ladder:Imagery Behavior:Sleep, Risk Display Format:Table:Imagery Behavior:Exercise |
|---|---|---|
| Comments | This study was designed as a 3X2 factorial design & only the risk display format intervention (risk ladder, table, or text) was looked at for this outcome, as participants had not yet received the mental imagery intervention, thus it could not affect this outcome. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1397 |
| Comments | ||
| Method | ANCOVA | |
| Comments | Covariates were sex, race, age, education, numeracy, and graph literacy. | |
| Title | Effect of the Intervention on Physical Activity Levels as Measured by Maintenance Self-efficacy |
|---|---|
| Description | Maintenance Self-efficacy is defined as being sure one can engage in physical activity even when it is hard Measured on a 4 point Likert Scale (range: 1=lower Maintenance Self-efficacy to 4=higher Maintenance Self-efficacy) Higher maintenance self-efficacy is considered a better outcome Note: to limit participant burden, the investigators used a single item instead of averaging across multiple items |
| Time Frame | 90 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| Due to the limitations of data collection & concerns about overburdening participants with too many survey questions, the investigators only assessed exercise-related maintenance self-efficacy among participants who engaged in the exercise-related mental imagery condition. |
| Arm/Group Title | Mental Imagery Behavior: Exercise |
|---|---|
| Arm/Group Description | -Participants engaged in mental imagery related to exercise goals |
| Measure Participants | 229 |
| Mean (Standard Error) [score on a scale] |
2.95
(0.05)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Risk Display Format:Risk Ladder:Imagery Behavior:Exercise |
|---|---|---|
| Comments | The secondary outcomes are hypothesized mediators of the effect of exercise-related mental imagery activities on future exercise behavior (e.g., exercise mental imagery will increase future exercise behavior by increasing exercise maintenance self-efficacy). Because these analyses are relevant only for the exercise condition, and the dichotomous mental imagery variable includes both exercise and sleep, it is not appropriate to include the dichtomous mental imagery variable in this analysis. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0070 |
| Comments | Covariates: sex, race, age, education, risk display issue, health literacy, season, acceptability, self-reported health, adherence, baseline exercise | |
| Method | Mixed Models Analysis | |
| Comments | ||
| Title | Effect of the Intervention on Physical Activity Levels as Measured by Recovery Self-efficacy |
|---|---|
| Description | Recovery Self-efficacy is defined as being sure one can re-engage in physical activity after putting it off Measured on a 4 point Likert Scale (range: 1=lower recovery Self-efficacy to 4=higher recovery Self-efficacy) Higher recovery self-efficacy is considered a better outcome Note: to limit participant burden, the investigators used a single item instead of averaging across multiple items |
| Time Frame | 90 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| Due to the limitations of data collection & concerns about overburdening participants with too many survey questions, the investigators only assessed exercise-related recovery self-efficacy among participants who engaged in the exercise-related mental imagery condition. |
| Arm/Group Title | Mental Imagery Behavior: Exercise |
|---|---|
| Arm/Group Description | -Participants engaged in mental imagery related to exercise goals |
| Measure Participants | 229 |
| Mean (Standard Error) [score on a scale] |
3.26
(0.05)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Risk Display Format:Risk Ladder:Imagery Behavior:Exercise |
|---|---|---|
| Comments | The secondary outcomes are hypothesized mediators of the effect of exercise-related mental imagery activities on future exercise behavior (e.g., exercise mental imagery will increase future exercise behavior by increasing exercise recovery self-efficacy). Because these analyses are relevant only for the exercise condition, and the dichotomous mental imagery variable includes both exercise and sleep, it is not appropriate to include the dichtomous mental imagery variable in this analysis. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.8793 |
| Comments | Covariates: sex, race, age, education, risk display issue, health literacy, season, acceptability, self-reported health, adherence, baseline exercise | |
| Method | Mixed Models Analysis | |
| Comments | ||
| Title | Effect of the Intervention on Physical Activity Levels as Measured by Affective Attitudes to Exercise - Enjoying Behavior |
|---|---|
| Description | Affective Attitudes to Exercise - Enjoying Behavior is defined as thinking getting regular exercise is enjoyable Measured on a 4 point Likert Scale (range: 1=lower Affective Attitudes to Exercise to 4=higher Affective Attitudes to Exercise) Higher Affective Attitudes to Exercise - Enjoying Behavior is considered a better outcome Note: to limit participant burden, the investigators used a single item instead of averaging across multiple items |
| Time Frame | 90 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| Due to the limitations of data collection and concerns about overburdening participants with too many survey questions, the investigators only assessed exercise-related affective attitudes among participants who engaged in the exercise-related mental imagery condition. |
| Arm/Group Title | Mental Imagery Behavior: Exercise |
|---|---|
| Arm/Group Description | -Participants engaged in mental imagery related to exercise goals |
| Measure Participants | 229 |
| Mean (Standard Error) [score on a scale] |
3.05
(0.05)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Risk Display Format:Risk Ladder:Imagery Behavior:Exercise |
|---|---|---|
| Comments | The secondary outcomes are hypothesized mediators of the effect of the exercise-related mental imagery activities on future exercise behavior (e.g., exercise mental imagery will increase future exercise behavior by increasing exercise affective attitudes). Because these analyses are relevant only for the exercise condition, and the dichotomous mental imagery variable includes both exercise and sleep, it is not appropriate to include the dichotomous mental imagery variable in this analysis. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.4673 |
| Comments | Covariates: sex, race, age, education, risk display issue, health literacy, season, acceptability, self-reported health, adherence, baseline exercise | |
| Method | Mixed Models Analysis | |
| Comments | ||
| Title | Effect of the Intervention on Physical Activity Levels as Measured by Affective Attitudes to Exercise - Thinking Behavior is Unpleasant |
|---|---|
| Description | Affective Attitudes to Exercise - Thinking Behavior is Unpleasant is defined as not thinking getting regular exercise is unpleasant Measured on a 4 point Likert Scale (range: 1=lower Affective Attitudes to Exercise to 4=higher Affective Attitudes to Exercise) Higher Affective Attitudes to Exercise - Thinking Behavior is Unpleasant is considered a better outcome Note: to limit participant burden, the investigators used a single item instead of averaging across multiple items |
| Time Frame | 90 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| Due to the limitations of data collection and concerns about overburdening participants with too many survey questions, the investigators only assessed exercise-related affective attitudes among participants who engaged in the exercise-related mental imagery condition. |
| Arm/Group Title | Mental Imagery Behavior: Exercise |
|---|---|
| Arm/Group Description | -Participants engaged in mental imagery related to exercise goals |
| Measure Participants | 229 |
| Mean (Standard Error) [score on a scale] |
3.19
(0.05)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Risk Display Format:Risk Ladder:Imagery Behavior:Exercise |
|---|---|---|
| Comments | The secondary outcomes are hypothesized mediators of the effect of the exercise-related mental imagery activities on future exercise behavior (e.g., exercise mental imagery will increase future exercise behavior by increasing exercise unpleasant feelings). Because these analyses are relevant only for the exercise condition, and the dichotomous mental imagery variable includes both exercise and sleep, it is not appropriate to include the dichotomous mental imagery variable in this analysis. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1916 |
| Comments | Covariates: sex, race, age, education, risk display issue, health literacy, season, acceptability, self-reported health, adherence, baseline exercise | |
| Method | Mixed Models Analysis | |
| Comments | ||
| Title | Effect of the Intervention on Physical Activity Levels as Measured by Perceived Vividness of Self-regulatory Imagery |
|---|---|
| Description | Perceived Vividness of Self-regulatory Imagery is defined as having clear and vivid images of steps towards getting physical activity Measured as an average of two variables measured on a 4 point Likert Scale (range: 1=lower Perceived Vividness of Self-regulatory Imagery to 4=higher Perceived Vividness of Self-regulatory Imagery) Higher Perceived Vividness of Self-regulatory Imagery is considered a better outcome Note: to limit participant burden, the investigators used a single item instead of averaging across multiple items |
| Time Frame | 90 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| Due to the limitations of data collection and concerns about overburdening participants with too many survey questions, the investigators only assessed exercise-related perceived vividness of self-regulatory imagery among participants who engaged in the exercise-related mental imagery condition. |
| Arm/Group Title | Mental Imagery Behavior: Exercise |
|---|---|
| Arm/Group Description | -Participants engaged in mental imagery related to exercise goals |
| Measure Participants | 229 |
| Mean (Standard Error) [score on a scale] |
3.36
(0.04)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Risk Display Format:Risk Ladder:Imagery Behavior:Exercise |
|---|---|---|
| Comments | The secondary outcomes are hypothesized mediators of the effect of the exercise-related mental imagery activities on future exercise behavior (e.g., exercise mental imagery will increase future exercise behavior by increasing exercise imagery vividness). Because these analyses are relevant only for the exercise condition, and the dichotomous mental imagery variable includes both exercise and sleep, it is not appropriate to include the dichotomous mental imagery variable in this analysis. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.8661 |
| Comments | Covariates: sex, race, age, education, risk display issue, health literacy, season, acceptability, self-reported health, adherence, baseline exercise | |
| Method | Mixed Models Analysis | |
| Comments | ||
| Title | Effect of the Intervention on Physical Activity Levels as Measured by Action Planning |
|---|---|
| Description | Action planning is defined as having a detailed plan about getting adequate physical activity Measured as an average of three variables measured on a 4 point Likert Scale (range: 1=lower action planning to 4=higher action planning) Higher action planning is considered a better outcome Note: to limit participant burden, the investigators used a single item instead of averaging across multiple items |
| Time Frame | 90 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| Due to the limitations of data collection and concerns about overburdening participants with too many survey questions, the investigators only assessed exercise-related action planning among participants who engaged in the exercise-related mental imagery condition. |
| Arm/Group Title | Mental Imagery Behavior: Exercise |
|---|---|
| Arm/Group Description | -Participants engaged in mental imagery related to exercise goals |
| Measure Participants | 229 |
| Mean (Standard Error) [score on a scale] |
3.52
(0.03)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Risk Display Format:Risk Ladder:Imagery Behavior:Exercise |
|---|---|---|
| Comments | The secondary outcomes are hypothesized mediators of the effect of the exercise-related mental imagery activities on future exercise behavior (e.g., exercise mental imagery will increase future exercise behavior by increasing exercise action planning). Because these analyses are relevant only for the exercise condition, and the dichotomous mental imagery variable includes both exercise and sleep, it is not appropriate to include the dichotomous mental imagery variable in this analysis. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0711 |
| Comments | Covariates: sex, race, age, education, risk display issue, health literacy, season, acceptability, self-reported health, adherence, baseline exercise | |
| Method | Mixed Models Analysis | |
| Comments | ||
| Title | Effect of the Intervention on Physical Activity Levels as Measured by Coping Planning |
|---|---|
| Description | Coping planning is defined as having a detailed plan of solving problems that may prevent getting adequate physical activity Measured on a 4 point Likert Scale (range: 1=lower Coping Planning to 4=higher Coping Planning) Higher coping planning is considered a better outcome Note: to limit participant burden, the investigators used a single item instead of averaging across multiple items |
| Time Frame | 90 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| Due to the limitations of data collection and concerns about overburdening participants with too many survey questions, the investigators only assessed exercise-related coping planning among participants who engaged in the exercise-related mental imagery condition. |
| Arm/Group Title | Mental Imagery Behavior: Exercise |
|---|---|
| Arm/Group Description | -Participants engaged in mental imagery related to exercise goals |
| Measure Participants | 229 |
| Mean (Standard Error) [score on a scale] |
2.98
(0.04)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Risk Display Format:Risk Ladder:Imagery Behavior:Exercise |
|---|---|---|
| Comments | The secondary outcomes are hypothesized mediators of the effect of the exercise-related mental imagery activities on future exercise behavior (e.g., exercise mental imagery will increase future exercise behavior by increasing exercise coping planning). Because these analyses are relevant only for the exercise condition, and the dichotomous mental imagery variable includes both exercise and sleep, it is not appropriate to include the dichotomous mental imagery variable in this analysis. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0365 |
| Comments | Covariates: sex, race, age, education, risk display issue, health literacy, season, acceptability, self-reported health, adherence, baseline exercise | |
| Method | Mixed Models Analysis | |
| Comments | ||
| Title | Effect of the Intervention on Physical Activity Levels as Measured by Action Self-efficacy |
|---|---|
| Description | Action self-efficacy is defined as having the confidence to engage in physical activity Measured on a 4 point Likert Scale (range: 1=lower Action Self-efficacy to 4=higher Action Self-efficacy) Higher Action Self-efficacy is considered a better outcome Note: to limit participant burden, the investigators used a single item instead of averaging across multiple items |
| Time Frame | 90 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| Due to the limitations of data collection and concerns about overburdening participants with too many survey questions, the investigators only assessed exercise-related action self-efficacy among participants who engaged in the exercise-related mental imagery condition. |
| Arm/Group Title | Mental Imagery Behavior: Exercise |
|---|---|
| Arm/Group Description | -Participants engaged in mental imagery related to exercise goals |
| Measure Participants | 229 |
| Mean (Standard Error) [score on a scale] |
3.36
(0.04)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Risk Display Format:Risk Ladder:Imagery Behavior:Exercise |
|---|---|---|
| Comments | The secondary outcomes are hypothesized mediators of the effect of the exercise-related mental imagery activities on future exercise behavior (e.g., exercise mental imagery will increase future exercise behavior by increasing exercise action self-efficacy). Because these analyses are relevant only for the exercise condition, and the dichotomous mental imagery variable includes both exercise and sleep, it is not appropriate to include the dichotomous mental imagery variable in this analysis. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1511 |
| Comments | Covariates: sex, race, age, education, risk display issue, health literacy, season, acceptability, self-reported health, adherence, baseline exercise | |
| Method | Mixed Models Analysis | |
| Comments | ||
Adverse Events
| Time Frame | Adverse events were not collected for this study. | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | Adverse events were not collected for this study. | |||||||||||
| Arm/Group Title | Risk Display Format:Risk Ladder:Imagery Behavior:Exercise | Risk Display Format:Risk Ladder:Imagery Behavior:Sleep | Risk Display Format:Table:Imagery Behavior:Exercise | Risk Display Format:Table:Imagery Behavior:Sleep | Risk Display Format:Text:Imagery Behavior:Exercise | Risk Display Format:Text:Imagery Behavior:Sleep | ||||||
| Arm/Group Description | With help from a research assistant, participants complete the Risk Assessment App. The App asks demographic & health questions. It then provides personalized risk estimates for participants' current activity level & how it would change with regular exercise. Participants take Baseline Survey 1. Participants listen to an audio recording that guides them through a mental imagery activity. They write down an exercise goal & are asked to practice the mental imagery twice a day for 3 weeks. Participants take Baseline Survey 2. Participants receive text messages reminding them to practice the mental imagery twice daily for 5 minutes each time (3 texts a week for 3 weeks). Participants take surveys via text at the end of each week for 4 weeks. 90 days post-baseline, participants complete a survey sent through the mail. Participants may be contacted for another survey 1 year later. | With help from a research assistant, participants complete the Risk Assessment App. The App asks demographic & health questions. It then provides personalized risk estimates for participants' current activity level & how it would change with regular exercise. Participants take Baseline Survey 1. Participants listen to an audio recording that guides them through a mental imagery activity. They write down a sleep goal & are asked to practice the mental imagery twice a day for 3 weeks. Participants take Baseline Survey 2. Participants receive text messages reminding them to practice the mental imagery twice daily for 5 minutes each time (3 texts a week for 3 weeks). Participants take surveys via text at the end of each week for 4 weeks. 90 days post-baseline, participants complete a survey sent through the mail. Participants may be contacted for another survey 1 year later. | With help from a research assistant, participants complete the Risk Assessment App. The App asks demographic & health questions. It then provides personalized risk estimates for participants' current activity level & how it would change with regular exercise. Participants take Baseline Survey 1. Participants listen to an audio recording that guides them through a mental imagery activity. They write down an exercise goal & are asked to practice the mental imagery twice a day for 3 weeks. Participants take Baseline Survey 2. Participants receive text messages reminding them to practice the mental imagery twice daily for 5 minutes each time (3 texts a week for 3 weeks). Participants take surveys via text at the end of each week for 4 weeks. 90 days post-baseline, participants complete a survey sent through the mail. Participants may be contacted for another survey 1 year later. | With help from a research assistant, participants complete the Risk Assessment App. The App asks demographic & health questions. It then provides personalized risk estimates for participants' current activity level & how it would change with regular exercise. Participants take Baseline Survey 1. Participants listen to an audio recording that guides them through a mental imagery activity. They write down a sleep goal & are asked to practice the mental imagery twice a day for 3 weeks. Participants take Baseline Survey 2. Participants receive text messages reminding them to practice the mental imagery twice daily for 5 minutes each time (3 texts a week for 3 weeks). Participants take surveys via text at the end of each week for 4 weeks. 90 days post-baseline, participants complete a survey sent through the mail. Participants may be contacted for another survey 1 year later. | With help from a research assistant, participants complete the Risk Assessment App. The App asks demographic & health questions. It then provides personalized risk estimates for participants' current activity level & how it would change with regular exercise. Participants take Baseline Survey 1. Participants listen to an audio recording that guides them through a mental imagery activity. They write down an exercise goal & are asked to practice the mental imagery twice a day for 3 weeks. Participants take Baseline Survey 2. Participants receive text messages reminding them to practice the mental imagery twice daily for 5 minutes each time (3 texts a week for 3 weeks). Participants take surveys via text at the end of each week for 4 weeks. 90 days post-baseline, participants complete a survey sent through the mail. Participants may be contacted for another survey 1 year later. | With help from a research assistant, participants complete the Risk Assessment App. The App asks demographic & health questions. It then provides personalized risk estimates for participants' current activity level & how it would change with regular exercise. Participants take Baseline Survey 1. Participants listen to an audio recording that guides them through a mental imagery activity. They write down a sleep goal & are asked to practice the mental imagery twice a day for 3 weeks. Participants take Baseline Survey 2. Participants receive text messages reminding them to practice the mental imagery twice daily for 5 minutes each time (3 texts a week for 3 weeks). Participants take surveys via text at the end of each week for 4 weeks. 90 days post-baseline, participants complete a survey sent through the mail. Participants may be contacted for another survey 1 year later. | ||||||
All Cause Mortality |
||||||||||||
| Risk Display Format:Risk Ladder:Imagery Behavior:Exercise | Risk Display Format:Risk Ladder:Imagery Behavior:Sleep | Risk Display Format:Table:Imagery Behavior:Exercise | Risk Display Format:Table:Imagery Behavior:Sleep | Risk Display Format:Text:Imagery Behavior:Exercise | Risk Display Format:Text:Imagery Behavior:Sleep | |||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/80 (0%) | 0/78 (0%) | 0/85 (0%) | 0/84 (0%) | 0/88 (0%) | 0/85 (0%) | ||||||
Serious Adverse Events |
||||||||||||
| Risk Display Format:Risk Ladder:Imagery Behavior:Exercise | Risk Display Format:Risk Ladder:Imagery Behavior:Sleep | Risk Display Format:Table:Imagery Behavior:Exercise | Risk Display Format:Table:Imagery Behavior:Sleep | Risk Display Format:Text:Imagery Behavior:Exercise | Risk Display Format:Text:Imagery Behavior:Sleep | |||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | ||||||
Other (Not Including Serious) Adverse Events |
||||||||||||
| Risk Display Format:Risk Ladder:Imagery Behavior:Exercise | Risk Display Format:Risk Ladder:Imagery Behavior:Sleep | Risk Display Format:Table:Imagery Behavior:Exercise | Risk Display Format:Table:Imagery Behavior:Sleep | Risk Display Format:Text:Imagery Behavior:Exercise | Risk Display Format:Text:Imagery Behavior:Sleep | |||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | ||||||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Erika Waters, MPH, Ph.D. |
|---|---|
| Organization | Washington University School of Medicine |
| Phone | 314-286-2757 |
| waterse@wustl.edu |
Responsible Party:
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT03255291
Other Study ID Numbers:
- 201706063
- R01CA190391
First Posted:
Aug 21, 2017
Last Update Posted:
Jan 18, 2020
Last Verified:
Jan 1, 2020