Clinical trial NCT00212238: Enhanced Internet Behavior Therapy for Treating Obesity
Official title: Enhanced Internet Behavior Therapy for Treating Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: 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
Lead sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Sponsor class: NIH
First posted: 2005-09-21
Enrollment: 100
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: weight change from 0 to 12 months
Secondary outcomes:
measure: patterns of weight change (0-3, 3-6, 6-12 months)
measure: change in waist circumference
measure: change in physical activity
measure: change in dietary intake
measure: change in social support
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Deborah F. Tate, PhD
role: PRINCIPAL_INVESTIGATOR
References: