Lay Health Coaches for Weight Loss: Peers Versus Mentors

Obesity Clinical Trial

Official title:

A Randomized Trial Testing Lay Health Coaches for Obesity Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01642199
• Other study ID #: 1R01DK095771-01
• Status: Completed
• Phase: N/A
• Start date: January 2013
• Est. completion date: February 2017

Study information

• Verified date: October 2019
• Source: University of Connecticut
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 278
• Est. completion date: February 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 60 Years

Eligibility

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).

Related Conditions & MeSH terms

• Obesity
• Weight Loss

Intervention

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).
• 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).
• Reduced Intensity Behavioral Weight Loss
Participants will receive 12 months of a reduced intensity group behavioral weight loss program.

Locations

Country	Name	City	State
United States	The Miriam Hospital's Weight Control and Diabetes Research Center	Providence	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
University of Connecticut	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight change from the initial assessment to the 12-month assessment measured on a digital scale to the nearest 0.1-kilogram		baseline to 12 months
Secondary	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.	2-weeks, 3-months, 6-months, 9-months, and 12-months