Lay Health Coaches for Weight Loss: Peers Versus Mentors

October 1, 2019 updated by: Tricia Leahey, University of Connecticut

A Randomized Trial Testing Lay Health Coaches for Obesity Treatment

The primary aim of this study is to determine whether reduced intensity behavioral weight loss treatment (rBWL) + Peer Health Coaches yields significantly greater weight loss than rBWL + Mentor Health Coaches and rBWL alone.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

278

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • The Miriam Hospital's Weight Control and Diabetes Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 60 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Body Mass Index between 30 and 40
  • Age between 40 and 60 years
  • English speaking

Exclusion Criteria:

  • Are unwilling to communicate regularly with a weight loss coach
  • Report not being able to walk 2 blocks (1/4 mile) without stopping
  • Are currently participating in a weight loss program, taking a weight loss medication, have a history of bariatric surgery, or lost ≥ 5% of body weight during the past 6-months
  • Are pregnant, lactating, less than 6-months post-partum, or plan to become pregnant during the intervention timeframe
  • 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 would jeopardize their safety if involved in a weight management program with diet and exercise guidelines
  • Report conditions that, in the judgment of the PI, would render the participant unlikely to follow the study protocol (e.g., relocation, dementia, terminal illness, substance abuse).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Reduced Intensity Behavioral Weight Loss + Peer Health Coach
Behavioral: Reduced Intensity Behavioral Weight Loss + Peer Health Coach
Participants will receive a 12-month reduced intensity group behavioral weight loss program. During weeks that there are no group meetings, participants will be coached by peers (i.e., other members of their weight loss group).
ACTIVE_COMPARATOR: Reduced Intensity Behavioral Weight Loss + Mentor Health Coach
Behavioral: Reduced Intensity Behavioral Weight Loss + Mentor Health Coach
Participants will receive a 12-month reduced intensity group behavioral weight loss program. During weeks that there are no group meetings, participants will be coached by a mentor (i.e., successful weight loser).
ACTIVE_COMPARATOR: Reduced Intensity Behavioral Weight Loss
Behavioral: Reduced Intensity Behavioral Weight Loss
Participants will receive 12 months of a reduced intensity group behavioral weight loss program.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Weight change from the initial assessment to the 12-month assessment measured on a digital scale to the nearest 0.1-kilogram
Time Frame: baseline to 12 months
baseline to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Direction of social comparison between participants and their Peer or Mentor weight loss coach
Time Frame: 2-weeks, 3-months, 6-months, 9-months, and 12-months
Participants in rBWL + Peer and rBWL + Mentor will complete a questionnaire that assesses whether their progress on weight loss, diet, and activity are "worse," "similar to," or "better" than their coach's on a 5-point likert scale. Mean scores on this measure will be reported.
2-weeks, 3-months, 6-months, 9-months, and 12-months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Connecticut

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (ACTUAL)

February 1, 2017

Study Completion (ACTUAL)

February 1, 2017

Study Registration Dates

First Submitted

July 12, 2012

First Submitted That Met QC Criteria

July 13, 2012

First Posted (ESTIMATE)

July 17, 2012

Study Record Updates

Last Update Posted (ACTUAL)

October 3, 2019

Last Update Submitted That Met QC Criteria

October 1, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1R01DK095771-01 (NIH)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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