NCT01211574

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for phase_2 obesity

Timeline
Completed

Started Sep 2010

Shorter than P25 for phase_2 obesity

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

September 28, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 29, 2010

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
Last Updated

July 13, 2012

Status Verified

July 1, 2012

Enrollment Period

7 months

First QC Date

September 28, 2010

Last Update Submit

July 12, 2012

Conditions

Outcome Measures

Primary Outcomes (1)

  • weight change

    0 to 6 months

Study Arms (3)

peer coach

EXPERIMENTAL

Participants will be coached by a peer between treatment visits.

Behavioral: peer coach

mentor

EXPERIMENTAL

Participants will be coached by a mentor between treatment visits

Behavioral: mentor

Professional

EXPERIMENTAL

Participants will be coached by an interventionist between treatment visits

Behavioral: Professional

Interventions

peer coachBEHAVIORAL

Participants will receive behavioral weight loss treatment and be coached by a peer between treatment visits.

peer coach
mentorBEHAVIORAL

Participants will receive behavioral weight loss treatment and be coached by a mentor between treatment visits.

mentor
ProfessionalBEHAVIORAL

Participants will receive behavioral weight loss treatment and be coached by a behavioral weight loss interventionist between treatment visits.

Professional

Eligibility Criteria

Age40 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • age 40-60

You may not qualify if:

  • Participants will be excluded if they:
  • Are unwilling to participate in a weight control program that includes weight coaches.
  • Report not being able to walk 2 blocks (1/4 mile) without stopping.
  • 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.
  • Are pregnant, lactating, less than 6 months post-partum or plan to become pregnant during the time of the intervention.
  • 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.
  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Tricia M Leahey, PhD

    The Miriam Hospital / Warren Alpert Medical School at Brown University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor (Research)

Study Record Dates

First Submitted

September 28, 2010

First Posted

September 29, 2010

Study Start

September 1, 2010

Primary Completion

April 1, 2011

Study Completion

April 1, 2011

Last Updated

July 13, 2012

Record last verified: 2012-07