Enhanced Internet Behavior Therapy for Treating Obesity

This study has been completed.
Sponsor:
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:
NCT00212238
First received: September 19, 2005
Last updated: March 17, 2010
Last verified: March 2010
  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

Resource links provided by NLM:


Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Primary Outcome Measures:
  • weight change from 0 to 12 months

Secondary Outcome Measures:
  • 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
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.

  Eligibility

Ages Eligible for Study:   21 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00212238

Locations
United States, North Carolina
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
Investigators
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
Body Weight
Nutrition Disorders
Overnutrition
Overweight
Signs and Symptoms

ClinicalTrials.gov processed this record on October 21, 2014