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Internet Assisted Obesity Treatment (iReach)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00265954
First Posted: December 15, 2005
Last Update Posted: January 22, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of Arkansas
Information provided by:
University of Vermont
  Purpose
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.

Condition Intervention Phase
Overweight Obesity Behavioral: internet, in-person and internet+in-person Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Trial of an Internet Versus In-person Behavioral Weight Loss Treatment Program.

Resource links provided by NLM:


Further study details as provided by University of Vermont:

Primary Outcome Measures:
  • Body Mass Index or body weight change [ Time Frame: 0, 6, 12, 18 month time points ]

Secondary Outcome Measures:
  • Social support, diet, exercise, adherence to treatment components [ Time Frame: 0, 6, 12, 18 months ]

Estimated Enrollment: 488
Study Start Date: February 2006
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • pregnancy
  • major medical problems
  • inability to walk for exercise
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00265954


Locations
United States, Arkansas
University of Arkansas for the Medical Sciences
Little Rock, Arkansas, United States, 72205
United States, Vermont
University of Vermont
Burlington, Vermont, United States, 05405
Sponsors and Collaborators
University of Vermont
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of Arkansas
Investigators
Principal Investigator: Jean Harvey-Berino, PhD University of Vermont
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jean Harvey-Berino, PhD, RD; Professor, Chair, University of Vermont
ClinicalTrials.gov Identifier: NCT00265954     History of Changes
Other Study ID Numbers: DK56746
R01DK056746 ( U.S. NIH Grant/Contract )
First Submitted: December 14, 2005
First Posted: December 15, 2005
Last Update Posted: January 22, 2010
Last Verified: January 2010

Additional relevant MeSH terms:
Obesity
Overweight
Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms