Partnership Optimizes Weight Management in Primary Care
PROMISE
Primary Care Obesity Management in the Southeast_PROMISE
2 other identifiers
interventional
375
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable obesity
Started Jan 2017
Longer than P75 for not_applicable obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 4, 2016
CompletedFirst Posted
Study publicly available on registry
November 8, 2016
CompletedStudy Start
First participant enrolled
January 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 15, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2025
CompletedDecember 17, 2025
December 1, 2025
4.3 years
November 4, 2016
December 12, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
body weight
change in body weight (kg) from baseline to follow-up assessments
6, 12, and 18 months
Secondary Outcomes (9)
physical activity
6, 12, and 18 months
treatment adherence
6, 12, and 18 months
treatment burden
6, 12, and 18 months
treatment satisfaction
6, 12, and 18 months
side effects
6, 12, and 18 months
- +4 more secondary outcomes
Study Arms (2)
Self-directed treatment
ACTIVE COMPARATORParticipants 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.
Peer coach treatment
EXPERIMENTALParticipants 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Alabama at Birmingham
Birmingham, Alabama, 35205, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gareth Dutton, PhD
University of Alabama at Birmingham
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Medicine
Study Record Dates
First Submitted
November 4, 2016
First Posted
November 8, 2016
Study Start
January 1, 2017
Primary Completion
April 15, 2021
Study Completion
December 1, 2025
Last Updated
December 17, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will share
With the documented permission of the IRB, the PI may develop a transportable de-identified database, codebook, and mechanism by which data can be shared with qualified investigators. Interested investigators will be asked to complete a standardized request form stating the specific aims of the analyses, the analytic plan, available resources for completing the proposed project, proposed timeline, and goals (i.e., manuscripts, presentations, and/or grant applications). The PI and research team will review these requests to determine whether the proposed analyses constitute an innovative and significant exploration of the data, whether the proposed team has sufficient resources to complete the request, and whether data will be adequately protected and managed. If any of these issues are problematic, the PI and research team will attempt to negotiate a fair resolution with the interested investigators and NIH program staff.