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
  Purpose

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.


Condition Intervention Phase
Obesity
Behavioral: Reduced Intensity Behavioral Weight Loss + Peer Health Coach
Behavioral: Reduced Intensity Behavioral Weight Loss + Mentor Health Coach
Behavioral: Reduced Intensity Behavioral Weight Loss
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Trial Testing Lay Health Coaches for Obesity Treatment

Resource links provided by NLM:


Further study details as provided by The Miriam Hospital:

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 [ Time Frame: baseline to 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 272
Study Start Date: January 2013
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   40 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01642199

Contacts
Contact: Tricia M Leahey, PhD tleahey@lifespan.org

Locations
United States, Rhode Island
The Miriam Hospital's Weight Control and Diabetes Research Center Recruiting
Providence, Rhode Island, United States, 02903
Contact: Andrea Grenga, BA       agrenga@lifespan.org   
Principal Investigator: Tricia M Leahey, PhD         
Sponsors and Collaborators
The Miriam Hospital
Investigators
Principal Investigator: Tricia M Leahey, PhD The Miriam Hospital / Warren Alpert Medical School at Brown University
  More Information

No publications provided

Responsible Party: Tricia M. Leahey, Ph.D., Assistant Professor (Research), The Miriam Hospital
ClinicalTrials.gov Identifier: NCT01642199     History of Changes
Other Study ID Numbers: 1R01DK095771-01
Study First Received: July 12, 2012
Last Updated: January 31, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by The Miriam Hospital:
obesity
weight loss
lay health coach
peer coach
mentor coach
reduced intensity weight loss program

Additional relevant MeSH terms:
Obesity
Weight Loss
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Body Weight Changes

ClinicalTrials.gov processed this record on July 20, 2014