Internet Assisted Obesity Treatment (iReach)

August 2, 2019 updated by: Jean R. Harvey, PhD, RD, University of Vermont

A Randomized Trial of an Internet Versus In-person Behavioral Weight Loss Treatment Program.

High quality behavioral weight loss programs are not widely accessible. The Internet offers one way to deliver health behavior programs to a wider audience. However, effective weight loss treatments are intensive and program delivery over the Internet may not be capable of duplicating the level of engagement typically generated during traditional in-person treatment. The goal of this study is to test the effectiveness of three weight loss interventions: Internet alone, Internet+periodic in-person support, and in-person alone. The investigators hypothesize that the in-person and internet+in-person interventions will produce better weight loss and maintenance than the internet only group.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Currently 65% of the adult population is overweight or obese. Unfortunately, safe and effective treatments for obesity are costly and intensive; therefore, this level of support is unlikely to be feasible in most clinical settings. Moreover, an additional limitation to current obesity treatment approaches is the limited reach and availability of programs for persons who work, live in rural areas or do not want, or cannot afford participation in group support classes. The advent of telecommunications technology may provide a solution to this dilemma. Telecommunications technology can presumably improve access to services and improve efficiency of delivery. Moreover, research examining new technologies such as the Internet, will provide information for policy makers interested in disseminating low-cost, high reach effective obesity treatment interventions. However, the effectiveness of the Internet for inducing weight loss has not been rigorously tested. Therefore, the overall goal of this project is to determine if obesity treatment can be effectively delivered over the Internet. A secondary aim is to evaluate whether the effectiveness of Internet interventions can be improved with the addition of minimal in-person support. Specifically, this project is a randomized, controlled clinical trial designed to test the translation of a behavioral weight loss program to the Internet (I). The I intervention will be compared to both an in-person condition (IP) and an Internet condition supplemented with periodic in-person support (I+IP). Subjects will be 488 (30% minority) overweight and obese adults recruited from Vermont and Arkansas who will participate in a 6-month behavioral weight control treatment program followed by 12 months of weight maintenance. Assessments will include measures of body weight, adherence to treatment goals, social influence components and frequency of use of Internet website features.

Study Type

Interventional

Enrollment (Actual)

481

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • University of Arkansas for the Medical Sciences
    • Vermont
      • Burlington, Vermont, United States, 05405
        • University of Vermont

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • >18 years old
  • BMI>25
  • Internet access

Exclusion Criteria:

  • pregnancy
  • major medical problems
  • inability to walk for exercise

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: 1
Individuals in this arm receive a 6 month behavioral weight loss intervention delivered on-line. Groups meet via a web chat weekly for 24 weeks and monthly for the following 12 months.
Behavioral: internet, in-person and internet+in-person
All participants receive an 18 month behavioral weight loss program that meets weekly for the first 6 months and monthly for the next year.
Experimental: 2
In-person; Individuals in the in-person condition attend weekly group behavioral weight loss sessions for 24 weeks and then monthly sessions for the following 12 months.
Behavioral: internet, in-person and internet+in-person
All participants receive an 18 month behavioral weight loss program that meets weekly for the first 6 months and monthly for the next year.
Experimental: 3
In-person+internet; Individuals in this condition receive a behavioral weight loss intervention over the internet weekly for 24 weeks and monthly for the following 12 months. Every month during the first 24 weeks and every third month during the following year they have an in-person meeting.
Behavioral: internet, in-person and internet+in-person
All participants receive an 18 month behavioral weight loss program that meets weekly for the first 6 months and monthly for the next year.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Body Mass Index or body weight change
Time Frame: 0, 6, 12, 18 month time points
0, 6, 12, 18 month time points

Secondary Outcome Measures

Outcome Measure
Time Frame
Social support, diet, exercise, adherence to treatment components
Time Frame: 0, 6, 12, 18 months
0, 6, 12, 18 months

Collaborators and Investigators

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

Sponsor

University of Vermont

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of Arkansas

Investigators

  • Principal Investigator: Jean Harvey-Berino, PhD, University of Vermont

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

February 1, 2006

Primary Completion (Actual)

October 1, 2009

Study Completion (Actual)

October 1, 2009

Study Registration Dates

First Submitted

December 14, 2005

First Submitted That Met QC Criteria

December 14, 2005

First Posted (Estimate)

December 15, 2005

Study Record Updates

Last Update Posted (Actual)

August 6, 2019

Last Update Submitted That Met QC Criteria

August 2, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DK56746
  • R01DK056746 (U.S. NIH Grant/Contract)

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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