Partnership Optimizes Weight Management in Primary Care

Not Applicable

Active, not recruiting

• Conditions: Obesity
• Interventions: Behavioral: weight loss intervention - peer coach; Behavioral: weight loss intervention - self directed

• Registration Number: NCT02959021
• Lead Sponsor: University of Alabama at Birmingham

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-11-04
• Study First Submitted QC: 2016-11-04
• Study First Posted: 2016-11-08
• Study Start: 2017-01
• Primary Completion: 2021-04-15
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-28
• Last Update Posted: 2024-10-30
• Study Completion: 2025-03

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 375

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Peer coach treatment	weight loss intervention - peer coach	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.
Self-directed treatment	weight loss intervention - self directed	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.

Primary Outcome Measures

Name	Time	Method
body weight	6, 12, and 18 months	change in body weight (kg) from baseline to follow-up assessments

Secondary Outcome Measures

Name	Time	Method
treatment adherence	6, 12, and 18 months	Treatment adherence will be assessed by the number of treatment sessions and phone calls completed.
quality of life	6, 12, and 18 months	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.
treatment burden	6, 12, and 18 months	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.
healthcare utilization	6, 12, and 18 months	Self-reported utilization of health care services (hospitalizations, ER/physician office visits, prescription drugs, etc.) and out-of-pocket costs will be collected.
side effects	6, 12, and 18 months	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.
physical and social functioning	6, 12, and 18 months	Items from the Patient Reported Outcome Measurement Information System (PROMIS) will be administered, including the 8-item short forms for physical and social functioning.
physical activity	6, 12, and 18 months	Self-reported physical activity assessed via the Paffenbarger Physical Activity Questionnaire (PPAQ).
treatment satisfaction	6, 12, and 18 months	Participants will complete self-report items assessing their attitudes and satisfaction regarding the weight loss intervention and weight loss achieved.
mood	6, 12, and 18 months	The Patient Health Questionnaire-8 (PHQ-8), a validated self-report measure of depressive symptoms experienced over the past two weeks, will be administered.

Trial Locations

Locations (1)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States