A Randomized, Controlled Pilot Study of a Patient-Initiated Approach to Increasing Weight Communication in Primary Care

Study Overview
=================
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.

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.

Official Title
-----------------
A Randomized, Controlled Pilot Study of a Patient-Initiated Approach to Increasing Weight Communication in Primary Care

Conditions
-----------------
Obesity, Primary Care, Health Communication

Intervention / Treatment
-----------------
* Behavioral: Brief waiting room pamphlet


Participation Criteria
=================
Eligibility 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, 1983) Indicate that they are 18 years or older Exclusion Criteria: - Indicate that they are Pregnant

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomization is stratified. On the screening form, participants indicate whether or not they plan to speak with their physician about their weight in their appointment. Randomization is stratified by if if the participant indicates that they plan to speak about weight or not.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Receive experiential pamphlet | Behavioral: Brief waiting room pamphlet<br>* 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.<br>|
| No Intervention: Control<br>No materials, usual care | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment Acceptability Questionnaire | 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. | Immediately after appointment (Same day as intervention delivery) | 
| Feasibility of Recruitment From Primary Care Waiting Room and Intervention Delivery | 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%). | When study staff is recruiting in the office during the data collection period, approx. 20 days over 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| If Weight Was Spoken About in the Appointment | Participants respond to Yes/No questions about content of their appointment | Immediately after appointment (Same day as intervention delivery) |