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Lay Health Coaches for Weight Loss: Peers Versus Mentors

Primary Purpose

Obesity

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Reduced Intensity Behavioral Weight Loss + Peer Health Coach

Reduced Intensity Behavioral Weight Loss + Mentor Health Coach

Reduced Intensity Behavioral Weight Loss

About this trial

This is an interventional treatment trial for Obesity focused on measuring obesity, weight loss, lay health coach, peer coach, mentor coach, reduced intensity weight loss program

Eligibility Criteria

40 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

The Miriam Hospital's Weight Control and Diabetes Research Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

Reduced Intensity Behavioral Weight Loss + Peer Health Coach

Reduced Intensity Behavioral Weight Loss + Mentor Health Coach

Reduced Intensity Behavioral Weight Loss

Arm Description

Outcomes

Primary Outcome Measures

Weight change from the initial assessment to the 12-month assessment measured on a digital scale to the nearest 0.1-kilogram

Secondary Outcome Measures

Direction of social comparison between participants and their Peer or Mentor weight loss coach

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.

Full Information

NCT ID

NCT01642199

First Posted

July 12, 2012

Last Updated

October 1, 2019

Sponsor

University of Connecticut

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT01642199

Brief Title

Lay Health Coaches for Weight Loss: Peers Versus Mentors

Official Title

A Randomized Trial Testing Lay Health Coaches for Obesity Treatment

Study Type

Interventional

2. Study Status

Record Verification Date

October 2019

Overall Recruitment Status

Completed

Study Start Date

January 2013 (undefined)

Primary Completion Date

February 2017 (Actual)

Study Completion Date

February 2017 (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)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obesity

Keywords

obesity, weight loss, lay health coach, peer coach, mentor coach, reduced intensity weight loss program

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

278 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Reduced Intensity Behavioral Weight Loss + Peer Health Coach

Arm Type

Active Comparator

Arm Title

Reduced Intensity Behavioral Weight Loss + Mentor Health Coach

Arm Type

Active Comparator

Arm Title

Reduced Intensity Behavioral Weight Loss

Arm Type

Active Comparator

Intervention Type

Behavioral

Intervention Name(s)

Reduced Intensity Behavioral Weight Loss + Peer Health Coach

Intervention Description

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).

Intervention Type

Behavioral

Intervention Name(s)

Reduced Intensity Behavioral Weight Loss + Mentor Health Coach

Intervention Description

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).

Intervention Type

Behavioral

Intervention Name(s)

Reduced Intensity Behavioral Weight Loss

Intervention Description

Participants will receive 12 months of a reduced intensity group behavioral weight loss program.

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

Direction of social comparison between participants and their Peer or Mentor weight loss coach

Description

Time Frame

2-weeks, 3-months, 6-months, 9-months, and 12-months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

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).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Tricia M Leahey, PhD

Organizational Affiliation

The Miriam Hospital / Warren Alpert Medical School at Brown University

Official's Role

Principal Investigator

Facility Information:

Facility Name

The Miriam Hospital's Weight Control and Diabetes Research Center

City

Providence

State/Province

Rhode Island

ZIP/Postal Code

02903

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

33252929

Citation

Leahey TM, Huedo-Medina TB, Grenga A, Gay L, Fernandes D, Denmat Z, Doyle C, Areny-Joval R, Wing RR. Patient-provided e-support in reduced intensity obesity treatment: The INSPIRE randomized controlled trial. Health Psychol. 2020 Dec;39(12):1037-1047. doi: 10.1037/hea0000996.

Results Reference

derived

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Lay Health Coaches for Weight Loss: Peers Versus Mentors

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