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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00265954
Other study ID # DK56746
Secondary ID R01DK056746
Status Completed
Phase N/A
First received
Last updated
Start date February 2006
Est. completion date October 2009

Study information

Verified date August 2019
Source University of Vermont
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 481
Est. completion date October 2009
Est. primary completion date October 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- >18 years old

- BMI>25

- Internet access

Exclusion Criteria:

- pregnancy

- major medical problems

- inability to walk for exercise

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States University of Vermont Burlington Vermont
United States University of Arkansas for the Medical Sciences Little Rock Arkansas

Sponsors (3)

Lead Sponsor Collaborator
University of Vermont National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of Arkansas

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Body Mass Index or body weight change 0, 6, 12, 18 month time points
Secondary Social support, diet, exercise, adherence to treatment components 0, 6, 12, 18 months
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