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| Sponsors and Collaborators: |
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) University of Arkansas |
| Information provided by: | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
| ClinicalTrials.gov Identifier: | NCT00265954 |
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. We 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 III |
| MedlinePlus related topics: | Obesity Weight Control |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study |
| Official Title: | A Randomized Trial of an Internet Versus in-Person Behavioral Weight Loss Treatment Program. |
| Estimated Enrollment: | 488 |
| Study Start Date: | February 2006 |
| Estimated Study Completion Date: | December 2009 |
| Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|
1: Experimental
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.
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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.
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2: Experimental
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.
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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.
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3: Experimental
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.
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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.
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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
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and 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 | |||||
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
| University of Arkansas |
| Principal Investigator: | Jean Harvey-Berino, PhD | University of Vermont |
More Information
| Responsible Party: | University of Vermont ( Jean Harvey-Berino, PhD, RD; Professor, Chair ) |
| Study ID Numbers: | DK56746, R01DK056746 |
| First Received: | December 14, 2005 |
| Last Updated: | March 14, 2008 |
| ClinicalTrials.gov Identifier: | NCT00265954 |
| Health Authority: | United States: Federal Government |
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