Lay Health Coaches for Weight Loss: Peers Versus Mentors

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by The Miriam Hospital
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Tricia M. Leahey, Ph.D., The Miriam Hospital
ClinicalTrials.gov Identifier:
NCT01642199
First received: July 12, 2012
Last updated: January 31, 2013
Last verified: January 2013

July 12, 2012
January 31, 2013
January 2013
December 2016   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01642199 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
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.
Same as current
Not Provided
Not Provided
 
Lay Health Coaches for Weight Loss: Peers Versus Mentors
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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Obesity
  • 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).
  • 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).
  • Behavioral: Reduced Intensity Behavioral Weight Loss
    Participants will receive 12 months of a reduced intensity group behavioral weight loss program.
  • Active Comparator: Reduced Intensity Behavioral Weight Loss + Peer Health Coach
    Intervention: Behavioral: Reduced Intensity Behavioral Weight Loss + Peer Health Coach
  • Active Comparator: Reduced Intensity Behavioral Weight Loss + Mentor Health Coach
    Intervention: Behavioral: Reduced Intensity Behavioral Weight Loss + Mentor Health Coach
  • Active Comparator: Reduced Intensity Behavioral Weight Loss
    Intervention: Behavioral: Reduced Intensity Behavioral Weight Loss
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
272
December 2016
December 2016   (final data collection date for primary outcome measure)

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).
Both
40 Years to 60 Years
Yes
Contact: Tricia M Leahey, PhD tleahey@lifespan.org
United States
 
NCT01642199
1R01DK095771-01
Yes
Tricia M. Leahey, Ph.D., The Miriam Hospital
The Miriam Hospital
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Principal Investigator: Tricia M Leahey, PhD The Miriam Hospital / Warren Alpert Medical School at Brown University
The Miriam Hospital
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP