A Randomized, Controlled Pilot Study of a Patient-Initiated Approach to Increasing Weight Communication in Primary Care
Study Details
Study Description
Brief Summary
This study tests the feasibility, acceptability, and preliminary efficacy of using a brief pamphlet in the primary care waiting room focused on promoting patient-initiated weight-related discussions in primary care appointments.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
N/A |
Detailed Description
Obesity is a chronic and complex disease that many national and professional organizations recommend be discussed frequently in primary care. However, rates of weight-related communication in primary care are suboptimal. When patients and physicians communicate about weight (defined as usage of any the 5As-ask, assess, advise, agree, and/or assist-in a weight-related conversation), patients are more likely to improve dietary habits, demonstrate more motivation for health behavior change, attempt weight loss treatment, and lose more weight as compared to patients who do not engage in weight-related communication with their physicians. Interventions have attempted to increase the rates of weight-related communication in primary care. However, they have focused solely on physicians and have only yielded modest efficacy. Intervention with patients on proposed patient-related barriers may be key to improving the rate of weight-related communication in primary care. The waiting room prior to appointments is an underutilized intervention setting. Prior waiting room interventions have shown promising results for increasing health communication between patients and physicians. However, no prior study has focused on weight-related communication. Thus, this study aims to test the feasibility, acceptability, and preliminary efficacy of an experiential pamphlet delivered in the waiting room targeting patient-related barriers to weight communication.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Intervention Receive experiential pamphlet |
Behavioral: Brief waiting room pamphlet
An experiential pamphlet including brief assessment questions and recommended questions for the participant to ask their physician based on their responses. Areas covered in the pamphlet include patients' knowledge of weight status and implications of weight, confidence in physicians' abilities to treat weight, stage of change for weight-related behaviors, and comfort in discussing their weight.
|
No Intervention: Control No materials, usual care |
Outcome Measures
Primary Outcome Measures
- Treatment Acceptability Questionnaire [Immediately after appointment (Same day as intervention delivery)]
Intervention participants reported acceptability, as measured by the Treatment Acceptability Questionnaire (Hunsley, 1992). This is a 6-item scale that asks the participant to rate several metrics of acceptability with Likert scale responses (individual items range 1-7, one item is reverse scored). A higher score indicates greater acceptability, a score of 21 is the benchmark for acceptability. Overall range of 6-42.
- Feasibility of Recruitment From Primary Care Waiting Room and Intervention Delivery [When study staff is recruiting in the office during the data collection period, approx. 20 days over 6 months]
Study flow will be tracked by study staff and compared to pre-determined benchmarks. 1) Percentage of patients who indicate verbal consent for screening (benchmark >70%), 2) percentage of eligible participants after screening (benchmark >50%), 3) percentage of participants who refuse to participate because of focus on weight (benchmark <20%), 4)percentage of participants who complete the experiential pamphlet (benchmark >80%).
Secondary Outcome Measures
- If Weight Was Spoken About in the Appointment [Immediately after appointment (Same day as intervention delivery)]
Participants respond to Yes/No questions about content of their appointment
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Present for an appointment at the Family Medicine Office
-
Indicate that they can speak and read English
-
Indicate that their Shape is > or = 5 on measure (Stunkard, Sørensen, & Schulsinger,
- Indicate that they are 18 years or older
Exclusion Criteria:
- Indicate that they are Pregnant
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Drexel University Family Medicine Office | Philadelphia | Pennsylvania | United States | 19127 |
Sponsors and Collaborators
- Drexel University
Investigators
- Principal Investigator: Jocelyn Remmert, MS, Drexel University
Study Documents (Full-Text)
More Information
Publications
None provided.- 1812006829
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail |
Arm/Group Title | Intervention | Control |
---|---|---|
Arm/Group Description | Receive experiential pamphlet Brief waiting room pamphlet: An experiential pamphlet including brief assessment questions and recommended questions for the participant to ask their physician based on their responses. Areas covered in the pamphlet include patients' knowledge of weight status and implications of weight, confidence in physicians' abilities to treat weight, stage of change for weight-related behaviors, and comfort in discussing their weight. | No materials, usual care |
Period Title: Overall Study | ||
STARTED | 32 | 30 |
Analysis | 30 | 30 |
COMPLETED | 30 | 30 |
NOT COMPLETED | 2 | 0 |
Baseline Characteristics
Arm/Group Title | Intervention | Control | Total |
---|---|---|---|
Arm/Group Description | Receive experiential pamphlet Brief waiting room pamphlet: An experiential pamphlet including brief assessment questions and recommended questions for the participant to ask their physician based on their responses. Areas covered in the pamphlet include patients' knowledge of weight status and implications of weight, confidence in physicians' abilities to treat weight, stage of change for weight-related behaviors, and comfort in discussing their weight. | No materials, usual care | Total of all reporting groups |
Overall Participants | 30 | 30 | 60 |
Age (years) [Mean (Standard Deviation) ] | |||
Mean (Standard Deviation) [years] |
43.1
(15.4)
|
38.2
(16.02)
|
40.6
(15.8)
|
Sex/Gender, Customized (Count of Participants) | |||
Male |
17
56.7%
|
14
46.7%
|
31
51.7%
|
Female |
13
43.3%
|
15
50%
|
28
46.7%
|
Transgender |
0
0%
|
1
3.3%
|
1
1.7%
|
Ethnicity (NIH/OMB) (Count of Participants) | |||
Hispanic or Latino |
1
3.3%
|
0
0%
|
1
1.7%
|
Not Hispanic or Latino |
29
96.7%
|
29
96.7%
|
58
96.7%
|
Unknown or Not Reported |
0
0%
|
1
3.3%
|
1
1.7%
|
Race (NIH/OMB) (Count of Participants) | |||
American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
Asian |
0
0%
|
2
6.7%
|
2
3.3%
|
Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
Black or African American |
11
36.7%
|
10
33.3%
|
21
35%
|
White |
16
53.3%
|
15
50%
|
31
51.7%
|
More than one race |
3
10%
|
3
10%
|
6
10%
|
Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
Region of Enrollment (participants) [Number] | |||
United States |
30
100%
|
30
100%
|
60
100%
|
Outcome Measures
Title | Treatment Acceptability Questionnaire |
---|---|
Description | Intervention participants reported acceptability, as measured by the Treatment Acceptability Questionnaire (Hunsley, 1992). This is a 6-item scale that asks the participant to rate several metrics of acceptability with Likert scale responses (individual items range 1-7, one item is reverse scored). A higher score indicates greater acceptability, a score of 21 is the benchmark for acceptability. Overall range of 6-42. |
Time Frame | Immediately after appointment (Same day as intervention delivery) |
Outcome Measure Data
Analysis Population Description |
---|
Only intervention participants saw the pamphlet and provided acceptability feedback |
Arm/Group Title | Intervention | Control |
---|---|---|
Arm/Group Description | Receive experiential pamphlet Brief waiting room pamphlet: An experiential pamphlet including brief assessment questions and recommended questions for the participant to ask their physician based on their responses. Areas covered in the pamphlet include patients' knowledge of weight status and implications of weight, confidence in physicians' abilities to treat weight, stage of change for weight-related behaviors, and comfort in discussing their weight. | No materials, usual care |
Measure Participants | 30 | 0 |
Mean (Standard Deviation) [units on a scale] |
35.8
(5.5)
|
Title | Feasibility of Recruitment From Primary Care Waiting Room and Intervention Delivery |
---|---|
Description | Study flow will be tracked by study staff and compared to pre-determined benchmarks. 1) Percentage of patients who indicate verbal consent for screening (benchmark >70%), 2) percentage of eligible participants after screening (benchmark >50%), 3) percentage of participants who refuse to participate because of focus on weight (benchmark <20%), 4)percentage of participants who complete the experiential pamphlet (benchmark >80%). |
Time Frame | When study staff is recruiting in the office during the data collection period, approx. 20 days over 6 months |
Outcome Measure Data
Analysis Population Description |
---|
Tracked by participant flow, 295 participants invited to participate by research staff, eventually resulting 135 assessed for eligibility, and ultimately 62 randomized |
Arm/Group Title | Feasibility, Tracked by Participant Flow |
---|---|
Arm/Group Description | Feasibility was measured by tracking flow and calculating: 1) Percentage of patients who indicate verbal consent for screening, 2) percentage of eligible participants after screening, 2) percentage of participants who refuse to participate because of focus on weight, 3)percentage of participants who complete the experiential pamphlet. Study flow will be tracked by study staff and compared to pre-determined benchmarks |
Measure Participants | 295 |
Percentage of participants indicated verbal consent for screening |
60
200%
|
Percentage of eligible participants after screening |
53.5
178.3%
|
Percentage of screened participants who refuse to participate because of focus on weight |
0
0%
|
Percentage of participants who complete the experiential pamphlet |
86.2
287.3%
|
Title | If Weight Was Spoken About in the Appointment |
---|---|
Description | Participants respond to Yes/No questions about content of their appointment |
Time Frame | Immediately after appointment (Same day as intervention delivery) |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Intervention | Control |
---|---|---|
Arm/Group Description | Receive experiential pamphlet Brief waiting room pamphlet: An experiential pamphlet including brief assessment questions and recommended questions for the participant to ask their physician based on their responses. Areas covered in the pamphlet include patients' knowledge of weight status and implications of weight, confidence in physicians' abilities to treat weight, stage of change for weight-related behaviors, and comfort in discussing their weight. | No materials, usual care |
Measure Participants | 30 | 30 |
Patient-initiated weight discussion occured |
7
23.3%
|
5
16.7%
|
Patient- or physician-initiated weight discussion occurred |
14
46.7%
|
11
36.7%
|
Adverse Events
Time Frame | Collected data from participants during primary care appointment (approx. 15-90 min), data collection occurred over a period of 6 months | |||
---|---|---|---|---|
Adverse Event Reporting Description | This was a brief, low risk study of providing a pamphlet about health and weight to patients in the waiting room before a primary care appointment | |||
Arm/Group Title | Intervention | Control | ||
Arm/Group Description | Receive experiential pamphlet Brief waiting room pamphlet: An experiential pamphlet including brief assessment questions and recommended questions for the participant to ask their physician based on their responses. Areas covered in the pamphlet include patients' knowledge of weight status and implications of weight, confidence in physicians' abilities to treat weight, stage of change for weight-related behaviors, and comfort in discussing their weight. | No materials, usual care | ||
All Cause Mortality |
||||
Intervention | Control | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/32 (0%) | 0/30 (0%) | ||
Serious Adverse Events |
||||
Intervention | Control | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/32 (0%) | 0/30 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
Intervention | Control | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/32 (0%) | 0/30 (0%) |
Limitations/Caveats
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.
Results Point of Contact
Name/Title | Jocelyn Remmert, PhD |
---|---|
Organization | Corporal Michael J. Crescenz VA Medical Center |
Phone | 215-823-5800 |
jocelyn.remmert@va.gov |
- 1812006829