Primary Care Obesity Management in the Southeast_PROMISE
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 375
- Locations
- 1
- Primary Endpoint
- body weight
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 21 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Self-directed treatment
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.
Intervention: weight loss intervention - self directed (Behavioral)
Peer coach treatment
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.
Intervention: weight loss intervention - peer coach (Behavioral)
Outcomes
Primary Outcomes
body weight
Time Frame: 6, 12, and 18 months
change in body weight (kg) from baseline to follow-up assessments
Secondary Outcomes
- treatment adherence(6, 12, and 18 months)
- quality of life(6, 12, and 18 months)
- treatment burden(6, 12, and 18 months)
- healthcare utilization(6, 12, and 18 months)
- side effects(6, 12, and 18 months)
- physical and social functioning(6, 12, and 18 months)
- physical activity(6, 12, and 18 months)
- treatment satisfaction(6, 12, and 18 months)
- mood(6, 12, and 18 months)
Investigators
Gareth R. Dutton PhD
Associate Professor of Medicine
University of Alabama at Birmingham