Partnership Optimizes Weight Management in Primary Care
NCT ID: NCT02959021
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
375 participants
INTERVENTIONAL
2017-01-31
2025-12-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
weight loss intervention - self directed
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.
weight loss intervention - peer coach
Interventions
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weight loss intervention - self directed
weight loss intervention - peer coach
Eligibility Criteria
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Inclusion Criteria
* Body mass index (BMI) 30-50 kg/m2
* Receiving primary care services at one of the practices participating in this study
Exclusion Criteria
* 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
21 Years
75 Years
ALL
Yes
Sponsors
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University of Alabama at Birmingham
OTHER
Responsible Party
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Gareth R. Dutton PhD
Associate Professor of Medicine
Principal Investigators
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Gareth Dutton, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Alabama at Birmingham
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Countries
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Provided Documents
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Document Type: Statistical Analysis Plan
Other Identifiers
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NIH R01DK106041
Identifier Type: -
Identifier Source: org_study_id