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Clinical Trials/NCT02959021
NCT02959021
Completed
Not Applicable

Primary Care Obesity Management in the Southeast_PROMISE

University of Alabama at Birmingham1 site in 1 country375 target enrollmentJanuary 1, 2017
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ConditionsObesity

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Obesity
Sponsor
University of Alabama at Birmingham
Enrollment
375
Locations
1
Primary Endpoint
body weight
Status
Completed
Last Updated
4 months ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2017
End Date
December 1, 2025
Last Updated
4 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Gareth R. Dutton PhD

Associate Professor of Medicine

University of Alabama at Birmingham

Eligibility Criteria

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

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)

Study Sites (1)

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