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Peer Support for Weight Loss Maintenance

Primary Purpose

Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Peer-delivered Weight Maintenance
Professionally-Delivered Weight Maintenance
Sponsored by
University of Connecticut
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring weight loss, weight maintenance, weight control, peer support, patient-provided care

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age between 18-75
  • Body Mass Index between 25-50
  • English Speaking

Exclusion Criteria:

  • Report being unable to walk 2 blocks without stopping
  • Are currently participating in weight loss treatment, have a history of bariatric surgery, or lost ≥5% in the past 6-months
  • Are pregnant or plan to become pregnant within 1 year
  • Report a heart condition, chest pain during periods of rest or activity, or loss of consciousness on the Physical Activity Readiness Questionnaire
  • Report a medical condition that could jeopardize their safety in a weight control program with diet and exercise guidelines
  • Report conditions that, in the judgment of the PI, would render them unlikely to follow the protocol (e.g., relocation, dementia, unable to read and write in English)
  • Have no Internet access.

Sites / Locations

  • UConn's Weight Management Research Group
  • Institute for Collaboration on Health, Intervention and Policy

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Peer-Delivered Weight Maintenance

Professionally-Delivered Weight Maintenance

Arm Description

Contingent upon participants losing 5% of body weight or more in Phase I (weight loss) of this trial, participants will receive an 18-month patient-delivered behavioral weight maintenance intervention. Specifically, group sessions will be delivered by a mentor (i.e., successful weight loser) and weekly coaching will be delivered by a peer (other member of their weight maintenance group).

Contingent upon participants losing 5% of body weight or more in Phase I (weight loss) of this trial, participants will receive an 18-month reduced intensity behavioral weight maintenance intervention, delivered by a professional. The intervention will consist of 24 group sessions.

Outcomes

Primary Outcome Measures

Weight Change (kg)
Weight change (measured on a digital scale to the nearest 0.1-kilogram) from the end of the Phase I weight loss program to the end of the Phase II maintenance program, which is 18 months long.

Secondary Outcome Measures

Blood pressure (mmHg)
Blood pressure (mmHg) from the end of the Phase I weight loss program to the end of the Phase II maintenance program, which is 18 months long.

Full Information

First Posted
December 29, 2017
Last Updated
April 5, 2023
Sponsor
University of Connecticut
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Stanford University, The Miriam Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03396653
Brief Title
Peer Support for Weight Loss Maintenance
Official Title
Peer Support for Weight Loss Maintenance
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
February 19, 2018 (Actual)
Primary Completion Date
March 16, 2023 (Actual)
Study Completion Date
March 21, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Connecticut
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Stanford University, The Miriam Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The primary aim of this study is to test the efficacy of patient-provided treatment for weight-loss maintenance.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
weight loss, weight maintenance, weight control, peer support, patient-provided care

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Peer-Delivered Weight Maintenance
Arm Type
Active Comparator
Arm Description
Contingent upon participants losing 5% of body weight or more in Phase I (weight loss) of this trial, participants will receive an 18-month patient-delivered behavioral weight maintenance intervention. Specifically, group sessions will be delivered by a mentor (i.e., successful weight loser) and weekly coaching will be delivered by a peer (other member of their weight maintenance group).
Arm Title
Professionally-Delivered Weight Maintenance
Arm Type
Active Comparator
Arm Description
Contingent upon participants losing 5% of body weight or more in Phase I (weight loss) of this trial, participants will receive an 18-month reduced intensity behavioral weight maintenance intervention, delivered by a professional. The intervention will consist of 24 group sessions.
Intervention Type
Behavioral
Intervention Name(s)
Peer-delivered Weight Maintenance
Intervention Description
Contingent upon participants losing 5% of body weight or more in Phase I (weight loss) of this trial, participants will receive an 18-month patient-delivered behavioral weight maintenance intervention. Specifically, group sessions will be delivered by a mentor (i.e., successful weight loser) and weekly coaching will be delivered by a peer (other member of their weight maintenance group).
Intervention Type
Behavioral
Intervention Name(s)
Professionally-Delivered Weight Maintenance
Intervention Description
Contingent upon participants losing 5% of body weight or more in Phase I (weight loss) of this trial, participants will receive an 18-month reduced intensity behavioral weight maintenance intervention, delivered by a professional. The intervention will consist of 24 group sessions.
Primary Outcome Measure Information:
Title
Weight Change (kg)
Description
Weight change (measured on a digital scale to the nearest 0.1-kilogram) from the end of the Phase I weight loss program to the end of the Phase II maintenance program, which is 18 months long.
Time Frame
Baseline to 18-months
Secondary Outcome Measure Information:
Title
Blood pressure (mmHg)
Description
Blood pressure (mmHg) from the end of the Phase I weight loss program to the end of the Phase II maintenance program, which is 18 months long.
Time Frame
Baseline to 18-months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age between 18-75 Body Mass Index between 25-50 English Speaking Exclusion Criteria: Report being unable to walk 2 blocks without stopping Are currently participating in weight loss treatment, have a history of bariatric surgery, or lost ≥5% in the past 6-months Are pregnant or plan to become pregnant within 1 year Report a heart condition, chest pain during periods of rest or activity, or loss of consciousness on the Physical Activity Readiness Questionnaire Report a medical condition that could jeopardize their safety in a weight control program with diet and exercise guidelines Report conditions that, in the judgment of the PI, would render them unlikely to follow the protocol (e.g., relocation, dementia, unable to read and write in English) Have no Internet access.
Facility Information:
Facility Name
UConn's Weight Management Research Group
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06103
Country
United States
Facility Name
Institute for Collaboration on Health, Intervention and Policy
City
Storrs
State/Province
Connecticut
ZIP/Postal Code
06269
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Peer Support for Weight Loss Maintenance

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