Enhanced Internet Behavior Therapy for Treating Obesity
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Purpose
The purpose of this study is to compare two Internet-based behavioral weight loss programs.
| Condition | Intervention |
|---|---|
|
Obesity |
Behavioral: internet behavioral weight loss program |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Enhanced Internet Behavior Therapy for Treating Obesity |
- weight change from 0 to 12 months
- 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
| Estimated Enrollment: | 100 |
| Study Start Date: | September 2003 |
| Estimated Study Completion Date: | October 2006 |
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.
Eligibility| Ages Eligible for Study: | 21 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations| United States, North Carolina | |
| University of North Carolina at Chapel Hill | |
| Chapel Hill, North Carolina, United States, 27599 | |
| Principal Investigator: | Deborah F. Tate, PhD | University of North Carolina, Chapel Hill |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00212238 History of Changes |
| Other Study ID Numbers: | R03 DK60058 (completed 2007) |
| Study First Received: | September 19, 2005 |
| Last Updated: | March 17, 2010 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
|
obesity weight loss Internet cognitive behavior therapy computer assisted patient care human therapy evaluation physical activity clinical trial nutrient intake activity outcomes research |
personal log /diary reinforcer self care social support network weight control behavioral /social science research tag clinical research human subject questionnaire |
Additional relevant MeSH terms:
|
Obesity Overnutrition Nutrition Disorders |
Overweight Body Weight Signs and Symptoms |
ClinicalTrials.gov processed this record on May 16, 2013