Partnership Optimizes Weight Management in Primary Care (PROMISE)

The University of Alabama at Birmingham

Status: Completed

Conditions: Obesity

Treatments: Behavioral: weight loss intervention - self directed; Behavioral: weight loss intervention - peer coach

Study type: Interventional

Funder types: Other

Identifiers

NCT02959021

R01DK106041 (U.S. NIH Grant/Contract)

NIH R01DK106041

Details and patient eligibility

About

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.

Enrollment: 375 patients

Sex: All

Ages: 21 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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375 participants in 2 patient groups

Self-directed treatment

Active Comparator group

Description:

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.

Treatment:

Behavioral: weight loss intervention - self directed

Peer coach treatment

Experimental group

Description:

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.

Treatment:

Behavioral: weight loss intervention - peer coach