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Partnership Optimizes Weight Management in Primary Care (PROMISE)

Primary Purpose

Obesity

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
weight loss intervention - self directed
weight loss intervention - peer coach
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring weight loss, behavioral, primary care, lifestyle

Eligibility Criteria

21 Years - 75 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • University of Alabama in Birmingham

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Self-directed treatment

Peer coach treatment

Arm 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.

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.

Outcomes

Primary Outcome Measures

body weight
change in body weight (kg) from baseline to follow-up assessments

Secondary Outcome Measures

physical activity
Self-reported physical activity assessed via the Paffenbarger Physical Activity Questionnaire (PPAQ).
treatment adherence
Treatment adherence will be assessed by the number of treatment sessions and phone calls completed.
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.
treatment satisfaction
Participants will complete self-report items assessing their attitudes and satisfaction regarding the weight loss intervention and weight loss achieved.
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.
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.
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.
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.
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.

Full Information

First Posted
November 4, 2016
Last Updated
September 18, 2023
Sponsor
University of Alabama at Birmingham
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1. Study Identification

Unique Protocol Identification Number
NCT02959021
Brief Title
Partnership Optimizes Weight Management in Primary Care
Acronym
PROMISE
Official Title
Primary Care Obesity Management in the Southeast_PROMISE
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 2017 (Actual)
Primary Completion Date
April 15, 2021 (Actual)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
weight loss, behavioral, primary care, lifestyle

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
375 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Self-directed treatment
Arm Type
Active Comparator
Arm 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.
Arm Title
Peer coach treatment
Arm Type
Experimental
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
weight loss intervention - self directed
Intervention Type
Behavioral
Intervention Name(s)
weight loss intervention - peer coach
Primary Outcome Measure Information:
Title
body weight
Description
change in body weight (kg) from baseline to follow-up assessments
Time Frame
6, 12, and 18 months
Secondary Outcome Measure Information:
Title
physical activity
Description
Self-reported physical activity assessed via the Paffenbarger Physical Activity Questionnaire (PPAQ).
Time Frame
6, 12, and 18 months
Title
treatment adherence
Description
Treatment adherence will be assessed by the number of treatment sessions and phone calls completed.
Time Frame
6, 12, and 18 months
Title
treatment burden
Description
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.
Time Frame
6, 12, and 18 months
Title
treatment satisfaction
Description
Participants will complete self-report items assessing their attitudes and satisfaction regarding the weight loss intervention and weight loss achieved.
Time Frame
6, 12, and 18 months
Title
side effects
Description
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.
Time Frame
6, 12, and 18 months
Title
quality of life
Description
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.
Time Frame
6, 12, and 18 months
Title
physical and social functioning
Description
Items from the Patient Reported Outcome Measurement Information System (PROMIS) will be administered, including the 8-item short forms for physical and social functioning.
Time Frame
6, 12, and 18 months
Title
mood
Description
The Patient Health Questionnaire-8 (PHQ-8), a validated self-report measure of depressive symptoms experienced over the past two weeks, will be administered.
Time Frame
6, 12, and 18 months
Title
healthcare utilization
Description
Self-reported utilization of health care services (hospitalizations, ER/physician office visits, prescription drugs, etc.) and out-of-pocket costs will be collected.
Time Frame
6, 12, and 18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gareth Dutton, PhD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama in Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

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Partnership Optimizes Weight Management in Primary Care

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