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Pilot Study Testing Professional, Peer, and Mentor Health Coaches for Weight Loss

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Tricia M. Leahey, Ph.D., The Miriam Hospital
ClinicalTrials.gov Identifier:
NCT01211574
First received: September 28, 2010
Last updated: July 12, 2012
Last verified: July 2012
  Purpose

Participants will be randomly assigned to 1 of 3 types of health coaches, Peers, Mentors, or Professionals. The aim of this study is to examine the feasibility and preliminary efficacy of health coaching for weight loss.


Condition Intervention Phase
Obesity
Behavioral: peer coach
Behavioral: mentor
Behavioral: Professional
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by The Miriam Hospital:

Primary Outcome Measures:
  • weight change [ Time Frame: 0 to 6 months ] [ Designated as safety issue: No ]

Enrollment: 44
Study Start Date: September 2010
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: peer coach
Participants will be coached by a peer between treatment visits.
Behavioral: peer coach
Participants will receive behavioral weight loss treatment and be coached by a peer between treatment visits.
Experimental: mentor
Participants will be coached by a mentor between treatment visits
Behavioral: mentor
Participants will receive behavioral weight loss treatment and be coached by a mentor between treatment visits.
Experimental: Professional
Participants will be coached by an interventionist between treatment visits
Behavioral: Professional
Participants will receive behavioral weight loss treatment and be coached by a behavioral weight loss interventionist between treatment visits.

  Eligibility

Ages Eligible for Study:   40 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • age 40-60

Exclusion Criteria:

  • Participants will be excluded if they:

    1. Are unwilling to participate in a weight control program that includes weight coaches.
    2. Report not being able to walk 2 blocks (1/4 mile) without stopping.
    3. Are 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.
    4. Are pregnant, lactating, less than 6 months post-partum or plan to become pregnant during the time of the intervention.
    5. Report a heart condition, chest pain during periods of rest or activity, or loss of consciousness on the Physical Activity Readiness Questionnaire (PAR-Q). Participants reporting joint problems, medication use, or other medical conditions that may limit their ability to exercise will be required to obtain written permission from their physician to participate in the intervention.
    6. Report conditions that, in the judgment of the PI, would render the participant unlikely to follow the study protocol (e.g., terminal illness, relocation, substance abuse, bulimia nervosa, dementia, or severe psychiatric condition).
  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: NCT01211574

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: NCT01211574     History of Changes
Other Study ID Numbers: 2044-10
Study First Received: September 28, 2010
Last Updated: July 12, 2012
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on November 27, 2014