Partnership Optimizes Weight Management in Primary Care

Study Overview
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Brief Summary
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The purpose of this study is to examine whether a primary care weight management intervention delivered by peer coaches produces greater weight loss than a self-directed program without peer coach support.

Official Title
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Primary Care Obesity Management in the Southeast_PROMISE

Conditions
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Obesity

Intervention / Treatment
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* Behavioral: weight loss intervention - self directed
* Behavioral: weight loss intervention - peer coach


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 21-75 years Body mass index (BMI) 30-50 kg/m2 Receiving primary care services at one of the practices participating in this study Exclusion Criteria: Uncontrolled hypertension (blood pressure >160/100 mm Hg at screening) Any of the following other medical conditions: myocardial infarction or cerebrovascular accident within the last six months; unstable angina within the past six months; NYHA Class III or IV congestive heart failure; type 1 diabetes; cancer requiring treatment in past five years (exception: non-melanoma skin cancer); and chronic lung diseases that limit physical activity Current use of any of the following medications: antipsychotic agents, monoamine oxidase inhibitors, systemic corticosteroids, or chemotherapeutic drugs; prescription weight loss medications (past six months) Unwilling or unable to do any of the following: give informed consent; read/understand English; accept random assignment; travel to the intervention site Likely to relocate out of the area in the next 2 years Participation in another randomized research project Weight loss > 10 pounds in past six months History of bariatric surgery

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Self-directed treatment<br>Participants randomly assigned to this arm will receive written and pre-recorded behavioral weight loss intervention materials (i.e., DVDs, online videos), and they will be instructed to work through the materials independently at their own pace. They will have continued physician contact as needed for routine medical care. | Behavioral: weight loss intervention - self directed<br> <br> |
| Experimental: Peer coach treatment<br>Participants randomly assigned to this arm will receive a combination of in-person, group-based behavioral weight loss sessions plus individual, telephone contacts. Groups and phone calls will be facilitated by a peer coach interventionist. Similar to the self-directed condition, participants will receive written and pre-recorded intervention materials (i.e., DVDs, online videos). They will also have continued contact with their physician for routine medical care. | Behavioral: weight loss intervention - peer coach<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| body weight | change in body weight (kg) from baseline to follow-up assessments | 6, 12, and 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| physical activity | Self-reported physical activity assessed via the Paffenbarger Physical Activity Questionnaire (PPAQ). | 6, 12, and 18 months | 
| treatment adherence | Treatment adherence will be assessed by the number of treatment sessions and phone calls completed. | 6, 12, and 18 months | 
| treatment burden | Behavioral burden of treatment will be assessed with self-report questionnaires including items about the perceived burden of behavioral targets such as self-monitoring, dietary changes, maintaining physical activity, and the impact of treatment on social relationships. | 6, 12, and 18 months | 
| treatment satisfaction | Participants will complete self-report items assessing their attitudes and satisfaction regarding the weight loss intervention and weight loss achieved. | 6, 12, and 18 months | 
| side effects | Symptom checklist including minor (e.g., constipation, dry mouth) and more severe events (e.g., cardiovascular events) will be administered to assess potential adverse side effects associated with treatment. | 6, 12, and 18 months | 
| quality of life | Quality of life will be assessed through the validated Short-Form 12 (SF-12), which provides measures of health-related quality of life for physical and mental health. | 6, 12, and 18 months | 
| physical and social functioning | Items from the Patient Reported Outcome Measurement Information System (PROMIS) will be administered, including the 8-item short forms for physical and social functioning. | 6, 12, and 18 months | 
| mood | The Patient Health Questionnaire-8 (PHQ-8), a validated self-report measure of depressive symptoms experienced over the past two weeks, will be administered. | 6, 12, and 18 months | 
| healthcare utilization | Self-reported utilization of health care services (hospitalizations, ER/physician office visits, prescription drugs, etc.) and out-of-pocket costs will be collected. | 6, 12, and 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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weight loss, behavioral, primary care, lifestyle