Planning the Next Steps: Using an Implementation Intention Approach to Increase Daily Walking

• Sponsor: Brandeis University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03124563
• Collaborator: (none)
• Enrollment: 63
• Arms: 2
• Actual Duration (Months): 16

Study Details

Study Description

Brief Summary

The study goal is to design an intervention utilizing implementation intentions to help participants prospectively plan and visualize ways to increase activity for the next day among working adults who do not currently exercise or use an activity monitor. Investigators will assess the level of and changes in physical activity, and how this relates to various individual factors that are related to exercise and health, including self-efficacy, control beliefs, and cognition.

Condition or Disease	Intervention/Treatment	Phase
Sedentary Lifestyle; Self Efficacy; Control Locus	Behavioral: Control Group; Behavioral: Implementation Intention Condition	N/A

Detailed Description

The 5-week study consists of a 1-week baseline, where participants are asked to wear a Fitbit to document the number of steps taken that day to establish an objective measurement of steps before the intervention began. In the intervention condition, after the baseline week, during weeks 2 to 5, this condition is prompted with an email each evening for four weeks to review their schedules for the following day and identify time slots where they could add activity. They are given instructions for providing a detailed calendar of appointments and open slots for the next day using a simple daily planner. The planning implementation intention manipulation involves recording specific information about when, where, and how they will add steps to their day. They are provided with maps near their home and work with specific information about distances, estimated time to walk between different points, and number of steps for specific routes to help them in planning for specific routes.The control condition is matched for how much contact they have with the research staff (called and emailed the same amount of times) and also wear the Fitbit daily. The only difference from the intervention group is that they do not get the daily planning instructions or maps for the implementation intention strategy treatment. All activity data from the Fitbit was deidentified and aggregated with an online platform called Fitabase.

Study Design

• Study Type: Interventional
• Actual Enrollment: 63 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Masking Description: The participants are aware of the nature of the intervention. They are not aware if they are the experimental or control group.
• Primary Purpose: Prevention
• Official Title: Planning the Next Steps: Using an Implementation Intention Approach to Increase Daily Walking
• Actual Study Start Date: Jun 1, 2015
• Actual Primary Completion Date: Oct 1, 2016
• Actual Study Completion Date: Oct 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Control group Participants will wear a Fitbit Zip to record their daily activity data, which will be deidentified and aggregated with an online platform called Fitabase. Participants in the control group will be matched with the intervention group for how much contact they have with the researcher.	Behavioral: Control Group; Participants will wear a Fitbit Zip for 5 weeks to record their daily activity data. The first week of the study will provide a baseline measurement of activity. After this week, participants in this condition will begin receiving daily emails asking them to report their step count in a questionnaire. Participants in the control group will be matched with the intervention group for how much contact they have with the researcher.
Experimental: Implementation Intention Condition Participants will wear a Fitbit Zip to record their daily activity data, which will be deidentified and aggregated with an online platform called Fitabase. Participants in this arm will receive all components of the intervention: scheduling, maps, and activity goals.	Behavioral: Implementation Intention Condition; Participants will wear a Fitbit Zip for 5 weeks to record their daily activity data. The first week of the study will provide a baseline measurement of activity. After this week, participants will be asked to increase their steps incrementally by 2,000 steps each week for the subsequent four weeks. To help achieve their step goals, they will receive maps of different routes near their home and/or work of varying distances and step counts. They will be asked to review their schedule for the next day and identify times when they could add steps into their schedules, and to record their daily step data in the daily questionnaire.

Outcome Measures

Primary Outcome Measures

1. Steps [Week 1 & Week 5]

   Weekly average of daily step counts with Fitbit (averaged across 7 days at Week 1 and averaged across 7 days at Week 5).

2. Activity Intensity [Week 1 & Week 5]

   Weekly average of daily time spent in moderate to vigorous intensity activity (averaged across 7 days at Week 1 and averaged across 7 days at Week 5).

Secondary Outcome Measures

1. Cognitive Composite Score [Baseline (Pre-Test) and Week 5 (Post-Test )]

   Z-score composite on the Brief Test of Adult Cognition by Telephone (BTACT). Individual tests scores were first standardized to z-scores. The z-score composite was calculated by averaging the z-scores of the 5 tests: word list immediate, word list delayed, backwards counting, digits backwards, and category fluency. Post-test z-scores were standardized based on the mean and s.d. of the pretest scores. A higher z-score is indicative of better cognitive functioning.

2. Exercise Control Beliefs [Baseline (Pre-Test) and Week 5 (Post-Test )]

   Degree of perceived control over Exercise. Range from 1 (Strongly agree) to 5 (strongly agree). Reverse coded so that a higher number indicates more perceived control over exercise.

3. Exercise Self-efficacy [Baseline (Pre-Test) and Week 5 (Post-Test )]

   Amount of confidence in ability to exercise.

4. Exercise Self-efficacy Beliefs - Time Composite [Baseline (Pre-Test) and Week 5 (Post-Test )]

   Amount of confidence in ability to exercise when facing time constraints. Range from 1 (Very Sure) to 4 (Not sure at all). Reverse coded so that a higher number indicates more self-efficacy. 3 items, summed to form time-relevant composite scale.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 35 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Currently working full time

• Not engaged in regular exercise

• 35 years of age or older

Exclusion Criteria:

• Not healthy enough to engage in a walking intervention

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Brandeis University

Investigators

• Principal Investigator: Margie Lachman, Ph.D., Brandeis University

Study Documents (Full-Text)

None provided.

More Information

Publications

• Robinson SA, Lachman ME. Perceived Control and Aging: A Mini-Review and Directions for Future Research. Gerontology. 2017;63(5):435-442. doi: 10.1159/000468540. Epub 2017 Apr 8. Review.
• Robinson, S. A. & Lachman, M. E. (2016). Perceived Control and Behavior Change: A Personalized Approach. In F. Infurna & J. Reich (Eds.), Perceived Control: Theory, Research, and Practice in the First 50 Years (pp. 201-227). New York, New York: Oxford University Press.

• Responsible Party: Brandeis University
• ClinicalTrials.gov Identifier: NCT03124563
• Other Study ID Numbers: WalkingIntentions #15147
• First Posted: Apr 24, 2017
• Last Update Posted: Jan 14, 2019
• Last Verified: Jul 1, 2018

• 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
• Keywords provided by Brandeis University: Exercise; Health Behavior; Aging

Study Results

Participant Flow

Arm/Group Title	Control Group	Implementation Intention Condition
Arm/Group Description	Participants will wear a Fitbit Zip to record their daily activity data, which will be deidentified and aggregated with an online platform called Fitabase. Participants in the control group will be matched with the intervention group for how much contact they have with the researcher. Participants will wear a Fitbit Zip for 5 weeks to record their daily activity data. The first week of the study will provide a baseline measurement of activity. After this week, participants in this condition will begin receiving daily emails asking them to report their step count in a questionnaire. Participants in the control group will be matched with the intervention group for how much contact they have with the researcher.	Participants will wear a Fitbit Zip to record their daily activity data, which will be deidentified and aggregated with an online platform called Fitabase. Participants in this arm will receive all components of the intervention: scheduling, maps, and activity goals. Participants will wear a Fitbit Zip for 5 weeks to record their daily activity data. The first week of the study will provide a baseline measurement of activity. After this week, participants will be asked to increase their steps incrementally by 2,000 steps each week for the subsequent four weeks. To help achieve their step goals, they will receive maps of different routes near their home and/or work of varying distances and step counts. They will be asked to review their schedule for the next day and identify times when they could add steps into their schedules, and to record their daily step data in the daily questionnaire.
Period Title: Overall Study
STARTED	32	31
Pre-test	30	30
COMPLETED	30	29
NOT COMPLETED	2	2

Baseline Characteristics

Arm/Group Title	Control Group	Implementation Intention Condition	Total
Arm/Group Description	Participants will wear a Fitbit Zip to record their daily activity data, which was deidentified and aggregated with an online platform called Fitabase. Participants in the control group will be matched with the intervention group for how much contact they have with the researcher. Participants will wear a Fitbit Zip for 5 weeks to record their daily activity data. The first week of the study will provide a baseline measurement of activity. After this week, participants in this condition will begin receiving daily emails asking them to report their step count in a questionnaire. Participants in the control group will be matched with the intervention group for how much contact they have with the researcher.	Participants will wear a Fitbit Zip to record their daily activity data, which will be deidentified and aggregated with an online platform called Fitabase. Participants in this arm will receive all components of the intervention: scheduling, maps, and activity goals. Participants will wear a Fitbit Zip for 5 weeks to record their daily activity data. The first week of the study will provide a baseline measurement of activity. After this week, participants will be asked to increase their steps incrementally by 2,000 steps each week for the subsequent four weeks. To help achieve their step goals, they will receive maps of different routes near their home and/or work of varying distances and step counts. They will be asked to review their schedule for the next day and identify times when they could add steps into their schedules, and to record their daily step data in the daily questionnaire.	Total of all reporting groups
Overall Participants	32	31	63
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	29 90.6%	30 96.8%	59 93.7%
>=65 years	3 9.4%	1 3.2%	4 6.3%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	52.22 (7.68)	46.33 (8.03)	49.37 (8.33)
Sex: Female, Male (Count of Participants)
Female	24 75%	22 71%	46 73%
Male	8 25%	9 29%	17 27%
Region of Enrollment (participants) [Number]
United States	32 100%	31 100%	63 100%

Outcome Measures

1. Primary Outcome

Title	Steps
Description	Weekly average of daily step counts with Fitbit (averaged across 7 days at Week 1 and averaged across 7 days at Week 5).
Time Frame	Week 1 & Week 5

Outcome Measure Data

Analysis Population Description

Analysis population based on participants that successfully synced their Fitbit and did not withdraw before the start of the study.

Arm/Group Title	Control Group	Implementation Intention Condition
Arm/Group Description	Participants will wear a Fitbit Zip to record their daily activity data, which will be deidentified and aggregated with an online platform called Fitabase. Participants in the control group will be matched with the intervention group for how much contact they have with the researcher. Participants will wear a Fitbit Zip for 5 weeks to record their daily activity data. The first week of the study will provide a baseline measurement of activity. After this week, participants in this condition will begin receiving daily emails asking them to report their step count in a questionnaire. Participants in the control group will be matched with the intervention group for how much contact they have with the researcher.	Participants will wear a Fitbit Zip to record their daily activity data, which will be deidentified and aggregated with an online platform called Fitabase. Participants in this arm will receive all components of the intervention: scheduling, maps, and activity goals. Participants will wear a Fitbit Zip for 5 weeks to record their daily activity data. The first week of the study will provide a baseline measurement of activity. After this week, participants will be asked to increase their steps incrementally by 2,000 steps each week for the subsequent four weeks. To help achieve their step goals, they will receive maps of different routes near their home and/or work of varying distances and step counts. They will be asked to review their schedule for the next day and identify times when they could add steps into their schedules, and to record their daily step data in the daily questionnaire.
Measure Participants	30	30
Week 1	6337.77 (2207.44)	6966.06 (2818.05)
Week 5	6109.46 (3308.75)	8900.35 (4416.04)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Control Group, Implementation Intention Condition
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	=.006
	Comments
	Method	Mixed Models Analysis
	Comments	Controlling for age, gender, and functional health

2. Primary Outcome

Title	Activity Intensity
Description	Weekly average of daily time spent in moderate to vigorous intensity activity (averaged across 7 days at Week 1 and averaged across 7 days at Week 5).
Time Frame	Week 1 & Week 5

Outcome Measure Data

Analysis Population Description

Analysis population based on participants that successfully synced their Fitbit and did not withdraw before the start of the study.

Arm/Group Title	Control Group	Implementation Intention Condition
Arm/Group Description	Participants will wear a Fitbit Zip to record their daily activity data, which will be deidentified and aggregated with an online platform called Fitabase. Participants in the control group will be matched with the intervention group for how much contact they have with the researcher. Participants will wear a Fitbit Zip for 5 weeks to record their daily activity data. The first week of the study will provide a baseline measurement of activity. After this week, participants in this condition will begin receiving daily emails asking them to report their step count in a questionnaire. Participants in the control group will be matched with the intervention group for how much contact they have with the researcher.	Participants will wear a Fitbit Zip to record their daily activity data, which will be deidentified and aggregated with an online platform called Fitabase. Participants in this arm will receive all components of the intervention: scheduling, maps, and activity goals. Participants will wear a Fitbit Zip for 5 weeks to record their daily activity data. The first week of the study will provide a baseline measurement of activity. After this week, participants will be asked to increase their steps incrementally by 2,000 steps each week for the subsequent four weeks. To help achieve their step goals, they will receive maps of different routes near their home and/or work of varying distances and step counts. They will be asked to review their schedule for the next day and identify times when they could add steps into their schedules, and to record their daily step data in the daily questionnaire.
Measure Participants	30	30
Week 1	18.71 (20.31)	22.25 (22.05)
Week 5	18.51 (25.84)	32.23 (30.73)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Control Group, Implementation Intention Condition
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.034
	Comments
	Method	Mixed Models Analysis
	Comments	Controlling for age, gender, and functional health

3. Secondary Outcome

Title	Cognitive Composite Score
Description	Z-score composite on the Brief Test of Adult Cognition by Telephone (BTACT). Individual tests scores were first standardized to z-scores. The z-score composite was calculated by averaging the z-scores of the 5 tests: word list immediate, word list delayed, backwards counting, digits backwards, and category fluency. Post-test z-scores were standardized based on the mean and s.d. of the pretest scores. A higher z-score is indicative of better cognitive functioning.
Time Frame	Baseline (Pre-Test) and Week 5 (Post-Test )

Outcome Measure Data

Analysis Population Description

Analysis population based on those who completed cognitive test at each testing point.

Arm/Group Title	Control Group	Implementation Intention Condition
Arm/Group Description	Participants will wear a Fitbit Zip to record their daily activity data, which will be deidentified and aggregated with an online platform called Fitabase. Participants in the control group will be matched with the intervention group for how much contact they have with the researcher. Participants will wear a Fitbit Zip for 5 weeks to record their daily activity data. The first week of the study will provide a baseline measurement of activity. After this week, participants in this condition will begin receiving daily emails asking them to report their step count in a questionnaire. Participants in the control group will be matched with the intervention group for how much contact they have with the researcher.	Participants will wear a Fitbit Zip to record their daily activity data, which will be deidentified and aggregated with an online platform called Fitabase. Participants in this arm will receive all components of the intervention: scheduling, maps, and activity goals. Participants will wear a Fitbit Zip for 5 weeks to record their daily activity data. The first week of the study will provide a baseline measurement of activity. After this week, participants will be asked to increase their steps incrementally by 2,000 steps each week for the subsequent four weeks. To help achieve their step goals, they will receive maps of different routes near their home and/or work of varying distances and step counts. They will be asked to review their schedule for the next day and identify times when they could add steps into their schedules, and to record their daily step data in the daily questionnaire.
Measure Participants	30	30
Pre-Test	-.17 (.70)	.17 (.48)
Post-Test	.21 (.50)	.65 (.52)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Control Group, Implementation Intention Condition
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.065
	Comments
	Method	Mixed Models Analysis
	Comments	Controlling for age, gender, and education

4. Secondary Outcome

Title	Exercise Control Beliefs
Description	Degree of perceived control over Exercise. Range from 1 (Strongly agree) to 5 (strongly agree). Reverse coded so that a higher number indicates more perceived control over exercise.
Time Frame	Baseline (Pre-Test) and Week 5 (Post-Test )

Outcome Measure Data

Analysis Population Description

Analysis population based on those who completed Control Beliefs over Exercise questionnaire at each testing point.

Arm/Group Title	Control Group	Implementation Intention Condition
Arm/Group Description	Participants will wear a Fitbit Zip to record their daily activity data, which will be deidentified and aggregated with an online platform called Fitabase. Participants in the control group will be matched with the intervention group for how much contact they have with the researcher. Participants will wear a Fitbit Zip for 5 weeks to record their daily activity data. The first week of the study will provide a baseline measurement of activity. After this week, participants in this condition will begin receiving daily emails asking them to report their step count in a questionnaire. Participants in the control group will be matched with the intervention group for how much contact they have with the researcher.	Participants will wear a Fitbit Zip to record their daily activity data, which will be deidentified and aggregated with an online platform called Fitabase. Participants in this arm will receive all components of the intervention: scheduling, maps, and activity goals. Participants will wear a Fitbit Zip for 5 weeks to record their daily activity data. The first week of the study will provide a baseline measurement of activity. After this week, participants will be asked to increase their steps incrementally by 2,000 steps each week for the subsequent four weeks. To help achieve their step goals, they will receive maps of different routes near their home and/or work of varying distances and step counts. They will be asked to review their schedule for the next day and identify times when they could add steps into their schedules, and to record their daily step data in the daily questionnaire.
Measure Participants	28	23
Pre-Test	4.26 (.52)	4.26 (.72)
Post-Test	4.32 (.54)	3.90 (.85)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Control Group, Implementation Intention Condition
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.308
	Comments
	Method	Mixed Models Analysis
	Comments	Controlling for age, gender, and level of education

5. Secondary Outcome

Title	Exercise Self-efficacy
Description	Amount of confidence in ability to exercise.
Time Frame	Baseline (Pre-Test) and Week 5 (Post-Test )

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control Group	Implementation Intention Condition
Arm/Group Description	Participants will wear a Fitbit Zip to record their daily activity data, which will be deidentified and aggregated with an online platform called Fitabase. Participants in the control group will be matched with the intervention group for how much contact they have with the researcher. Participants will wear a Fitbit Zip for 5 weeks to record their daily activity data. The first week of the study will provide a baseline measurement of activity. After this week, participants in this condition will begin receiving daily emails asking them to report their step count in a questionnaire. Participants in the control group will be matched with the intervention group for how much contact they have with the researcher.	Participants will wear a Fitbit Zip to record their daily activity data, which will be deidentified and aggregated with an online platform called Fitabase. Participants in this arm will receive all components of the intervention: scheduling, maps, and activity goals. Participants will wear a Fitbit Zip for 5 weeks to record their daily activity data. The first week of the study will provide a baseline measurement of activity. After this week, participants will be asked to increase their steps incrementally by 2,000 steps each week for the subsequent four weeks. To help achieve their step goals, they will receive maps of different routes near their home and/or work of varying distances and step counts. They will be asked to review their schedule for the next day and identify times when they could add steps into their schedules, and to record their daily step data in the daily questionnaire.
Measure Participants	27	23
Pre-test	2.15 (0.99)	2.19 (0.81)
Post-test	2.16 (0.86)	2.29 (0.92)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Control Group, Implementation Intention Condition
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.349
	Comments
	Method	ANOVA
	Comments

6. Secondary Outcome

Title	Exercise Self-efficacy Beliefs - Time Composite
Description	Amount of confidence in ability to exercise when facing time constraints. Range from 1 (Very Sure) to 4 (Not sure at all). Reverse coded so that a higher number indicates more self-efficacy. 3 items, summed to form time-relevant composite scale.
Time Frame	Baseline (Pre-Test) and Week 5 (Post-Test )

Outcome Measure Data

Analysis Population Description

Analysis population based on those who completed Exercise Self-efficacy Beliefs questionnaire at each testing point.

Arm/Group Title	Control Group	Implementation Intention Condition
Arm/Group Description	Participants will wear a Fitbit Zip to record their daily activity data, which will be deidentified and aggregated with an online platform called Fitabase. Participants in the control group will be matched with the intervention group for how much contact they have with the researcher. Participants will wear a Fitbit Zip for 5 weeks to record their daily activity data. The first week of the study will provide a baseline measurement of activity. After this week, participants in this condition will begin receiving daily emails asking them to report their step count in a questionnaire. Participants in the control group will be matched with the intervention group for how much contact they have with the researcher.	Participants will wear a Fitbit Zip to record their daily activity data, which will be deidentified and aggregated with an online platform called Fitabase. Participants in this arm will receive all components of the intervention: scheduling, maps, and activity goals. Participants will wear a Fitbit Zip for 5 weeks to record their daily activity data. The first week of the study will provide a baseline measurement of activity. After this week, participants will be asked to increase their steps incrementally by 2,000 steps each week for the subsequent four weeks. To help achieve their step goals, they will receive maps of different routes near their home and/or work of varying distances and step counts. They will be asked to review their schedule for the next day and identify times when they could add steps into their schedules, and to record their daily step data in the daily questionnaire.
Measure Participants	24	23
Pre-Test	1.96 (1.05)	1.90 (.75)
Post-Test	1.94 (.89)	2.30 (.90)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Control Group, Implementation Intention Condition
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.022
	Comments
	Method	Mixed Models Analysis
	Comments	Controlling for age, gender, and level of education

Adverse Events

Arm/Group Title	Control Group		Implementation Intention Condition
Arm/Group Description	Participants will wear a Fitbit Zip to record their daily activity data, which will be deidentified and aggregated with an online platform called Fitabase. Participants in the control group will be matched with the intervention group for how much contact they have with the researcher. Assigned Intervention - Participants will wear a Fitbit Zip for 5 weeks to record their daily activity data. The first week of the study will provide a baseline measurement of activity. After this week, participants in this condition will begin receiving daily emails asking them to report their step count in a questionnaire. Participants in the control group will be matched with the intervention group for how much contact they have with the researcher.		Participants will wear a Fitbit Zip to record their daily activity data, which will be deidentified and aggregated with an online platform called Fitabase. Participants in this arm will receive all components of the intervention: scheduling, maps, and activity goals. Participants will wear a Fitbit Zip for 5 weeks to record their daily activity data. The first week of the study will provide a baseline measurement of activity. After this week, participants will be asked to increase their steps incrementally by 2,000 steps each week for the subsequent four weeks. To help achieve their step goals, they will receive maps of different routes near their home and/or work of varying distances and step counts. They will be asked to review their schedule for the next day and identify times when they could add steps into their schedules, and to record their daily step data in the daily questionnaire.
All Cause Mortality
	Control Group		Implementation Intention Condition
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Control Group		Implementation Intention Condition
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/32 (0%)		0/30 (0%)
Other (Not Including Serious) Adverse Events
	Control Group		Implementation Intention Condition
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/32 (0%)		0/30 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT 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.