Partnership Optimizes Weight Management in Primary Care (PROMISE)

Primary Care Obesity Management in the Southeast_PROMISE

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 Overview

• Status: Active, not recruiting
• Conditions: Obesity
• Intervention / Treatment: Behavioral: weight loss intervention - self directed; Behavioral: weight loss intervention - peer coach

• Study Type: Interventional
• Enrollment (Actual): 375
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • University of Alabama in Birmingham

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Behavioral: weight loss intervention - self directed
Experimental: 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.	Behavioral: weight loss intervention - peer coach

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
body weight	change in body weight (kg) from baseline to follow-up assessments	6, 12, and 18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
physical activity	Self-reported physical activity assessed via the Paffenbarger Physical Activity Questionnaire (PPAQ).	6, 12, and 18 months
treatment adherence	Treatment adherence will be assessed by the number of treatment sessions and phone calls completed.	6, 12, and 18 months
treatment burden	Behavioral burden of treatment will be assessed with self-report questionnaires including items about the perceived burden of behavioral targets such as self-monitoring, dietary changes, maintaining physical activity, and the impact of treatment on social relationships.	6, 12, and 18 months
treatment satisfaction	Participants will complete self-report items assessing their attitudes and satisfaction regarding the weight loss intervention and weight loss achieved.	6, 12, and 18 months
side effects	Symptom checklist including minor (e.g., constipation, dry mouth) and more severe events (e.g., cardiovascular events) will be administered to assess potential adverse side effects associated with treatment.	6, 12, and 18 months
quality of life	Quality of life will be assessed through the validated Short-Form 12 (SF-12), which provides measures of health-related quality of life for physical and mental health.	6, 12, and 18 months
physical and social functioning	Items from the Patient Reported Outcome Measurement Information System (PROMIS) will be administered, including the 8-item short forms for physical and social functioning.	6, 12, and 18 months
mood	The Patient Health Questionnaire-8 (PHQ-8), a validated self-report measure of depressive symptoms experienced over the past two weeks, will be administered.	6, 12, and 18 months
healthcare utilization	Self-reported utilization of health care services (hospitalizations, ER/physician office visits, prescription drugs, etc.) and out-of-pocket costs will be collected.	6, 12, and 18 months

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Investigators: Principal Investigator: Gareth Dutton, PhD, University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): April 15, 2021
• Study Completion (Estimated): March 1, 2024

Study Registration Dates

• First Submitted: November 4, 2016
• First Submitted That Met QC Criteria: November 4, 2016
• First Posted (Estimated): November 8, 2016

Study Record Updates

• Last Update Posted (Actual): January 5, 2024
• Last Update Submitted That Met QC Criteria: January 3, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: primary care; weight loss; lifestyle; behavioral
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: NIH R01DK106041

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.