Lay Health Coaches for Weight Loss: Peers Versus Mentors
This study is currently recruiting participants.
Verified January 2013 by The Miriam Hospital
Sponsor:
The Miriam Hospital
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
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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
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 May 22, 2013