Clinical Trial: Internet Assisted Obesity Treatment
This study is not yet open for patient recruitment.
Verified by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) December 2005
| Sponsored by: | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | | 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
| Behavior: Behavioral weight loss therapy
| Phase III
|
MedlinePlus related topics: Obesity
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.
Further study details as provided by National Institute of
Diabetes and Digestive and
Kidney Diseases (NIDDK):
Primary Outcomes: Body Mass Index or body weight change measured at 0, 6, 12, and 18 month timepoints
Secondary Outcomes: Social support, diet, exercise, adherence to treatment components
Expected Total Enrollment: 488
Study start: February 2006; Expected completion: March 2010
Last follow-up: December 2009; Data entry closure: December 2009
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 above, Genders Eligible for Study: Both
Accepts Healthy Volunteers
Criteria
Inclusion Criteria:
>18 years old BMI<25 Internet access -
Exclusion Criteria:
pregnancy major medical problems inability to walk for exercise
-
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00265954
Beth Gold (802) 656-1960 egold@uvm.edu
Arkansas University of Arkansas for the Medical Sciences, Little Rock, Arkansas, 72205, United States
Delia Smith West, PhD 501-526-6623 dswest1@uams.edu
Study chairs or principal investigators
Jean Harvey-Berino, PhD, Principal Investigator, University of Vermont
More Information
Study ID Numbers: DK56746
Last Updated: December 14, 2005
Record first received: December 14, 2005
ClinicalTrials.gov Identifier: NCT00265954
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2006-01-10
Source: ClinicalTrials.gov
Cache Date: January 11, 2006