NCT01642199

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
278

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Jan 2013

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 12, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 17, 2012

Completed
6 months until next milestone

Study Start

First participant enrolled

January 1, 2013

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

October 3, 2019

Status Verified

October 1, 2019

Enrollment Period

4.1 years

First QC Date

July 12, 2012

Last Update Submit

October 1, 2019

Conditions

Keywords

obesityweight losslay health coachpeer coachmentor coachreduced intensity weight loss program

Outcome Measures

Primary Outcomes (1)

  • Weight change from the initial assessment to the 12-month assessment measured on a digital scale to the nearest 0.1-kilogram

    baseline to 12 months

Secondary Outcomes (1)

  • Direction of social comparison between participants and their Peer or Mentor weight loss coach

    2-weeks, 3-months, 6-months, 9-months, and 12-months

Study Arms (3)

Reduced Intensity Behavioral Weight Loss + Peer Health Coach

ACTIVE COMPARATOR
Behavioral: Reduced Intensity Behavioral Weight Loss + Peer Health Coach

Reduced Intensity Behavioral Weight Loss + Mentor Health Coach

ACTIVE COMPARATOR
Behavioral: Reduced Intensity Behavioral Weight Loss + Mentor Health Coach

Reduced Intensity Behavioral Weight Loss

ACTIVE COMPARATOR
Behavioral: Reduced Intensity Behavioral Weight Loss

Interventions

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).

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 a mentor (i.e., successful weight loser).

Reduced Intensity Behavioral Weight Loss + Mentor Health Coach

Participants will receive 12 months of a reduced intensity group behavioral weight loss program.

Reduced Intensity Behavioral Weight Loss

Eligibility Criteria

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

You may qualify if:

  • Body Mass Index between 30 and 40
  • Age between 40 and 60 years
  • English speaking

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Miriam Hospital's Weight Control and Diabetes Research Center

Providence, Rhode Island, 02903, United States

Location

Related Publications (1)

  • Leahey TM, Huedo-Medina TB, Grenga A, Gay L, Fernandes D, Denmat Z, Doyle C, Areny-Joval R, Wing RR. Patient-provided e-support in reduced intensity obesity treatment: The INSPIRE randomized controlled trial. Health Psychol. 2020 Dec;39(12):1037-1047. doi: 10.1037/hea0000996.

MeSH Terms

Conditions

ObesityWeight Loss

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Study Officials

  • Tricia M Leahey, PhD

    The Miriam Hospital / Warren Alpert Medical School at Brown University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 12, 2012

First Posted

July 17, 2012

Study Start

January 1, 2013

Primary Completion

February 1, 2017

Study Completion

February 1, 2017

Last Updated

October 3, 2019

Record last verified: 2019-10

Locations