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Clinical Trials/NCT00212238
NCT00212238
Completed
Not Applicable

Enhanced Internet Behavior Therapy for Treating Obesity

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)1 site in 1 country100 target enrollmentSeptember 2003
ConditionsObesity

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Obesity
Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Enrollment
100
Locations
1
Primary Endpoint
weight change from 0 to 12 months
Status
Completed
Last Updated
16 years ago

Overview

Brief Summary

The purpose of this study is to compare two Internet-based behavioral weight loss programs.

Detailed Description

Given the increasing prevalence of obesity and fact that many adults have a strong preference to lose weight without attending weekly treatment meetings, there is need to develop effective alternatives to behavioral lifestyle interventions requiring less face-to-face contact. The Internet offers exciting opportunities to deliver behavior change interventions that minimize face-to-face interaction. We have recently developed and tested an Internet behavioral weight loss program compared with an Internet educational program in a randomized trial and found the behavioral program produced significantly better weight losses (4.1 kg) at 6 months. Our study clearly establishes the potential for using the Internet to deliver alternative treatment programs; however, treatment efficacy research is needed to further develop an Internet approach that will promote longer-term weight loss. The objectives of the proposed study are I) to enhance our Internet program to develop a state of the art Internet Cognitive-Behavior Therapy (I-CBT) program for obesity treatment; and 2) to conduct a randomized trial comparing the enhanced program with a Minimal CBT program also delivered via the Internet. We propose to recruit 100 overweight adults and randomly assign them to Enhanced Internet CBT or Minimal Internet CBT programs. The Minimal I-CBT condition will be given links to weight loss websites, weekly structured cognitive-behavioral lessons for weight loss, weekly prompting, and an on-line bulletin board. The Enhanced I-CBT program will have these same features plus weekly on-line group therapy sessions, computer-aided self-monitoring diaries, and weekly individual e-mail feedback from a therapist. The primary outcome is weight loss from 0-12 months. Secondary outcomes will examine patterns of weight change and changes in waist, diet, physical activity, and social support. The proposed research has significant implications for expanding the audience served by obesity treatment program by using the Internet. This study utilizes an innovative approach and extends our programmatic research on the development of a cognitive-behavioral Internet treatment for obesity.

Registry
clinicaltrials.gov
Start Date
September 2003
End Date
October 2006
Last Updated
16 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • BMI 25 to 40

Exclusion Criteria

  • heart attack, stroke, cancer in the last 5 years, angina, diabetes that is treated with oral agents or insulin (people with type 2 diabetes whose disease is controlled through diet and exercise alone will be considered eligible), orthopedic or joint problems that would prohibit exercise;
  • major psychiatric diagnoses and organic brain syndromes;
  • pregnant, lactating, less than 6 months post-partum, or plan to become pregnant w/in 12 mos.
  • currently taking weight loss medications or lost \> 5% of body weight during the past 6 months;
  • intend to move to another city within the 12 month study duration;
  • have another family member living in the household enrolled in the study
  • heart problems, frequent chest pains, or faintness or dizziness

Outcomes

Primary Outcomes

weight change from 0 to 12 months

Secondary Outcomes

  • patterns of weight change (0-3, 3-6, 6-12 months)
  • change in waist circumference
  • change in physical activity
  • change in dietary intake
  • change in social support

Study Sites (1)

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