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

July 12, 2012 updated by: Tricia M. Leahey, Ph.D., The Miriam Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Phase 2
  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
weight change
Time Frame: 0 to 6 months
0 to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Miriam Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Actual)

April 1, 2011

Study Completion (Actual)

April 1, 2011

Study Registration Dates

First Submitted

September 28, 2010

First Submitted That Met QC Criteria

September 28, 2010

First Posted (Estimate)

September 29, 2010

Study Record Updates

Last Update Posted (Estimate)

July 13, 2012

Last Update Submitted That Met QC Criteria

July 12, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Other Study ID Numbers

  • 2044-10

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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