Enhanced Internet Behavior Therapy for Treating Obesity

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

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Behavioral: internet behavioral weight loss program

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.

• Study Type: Interventional
• Enrollment: 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina at Chapel Hill

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
weight change from 0 to 12 months

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

• Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: Deborah F. Tate, PhD, University of North Carolina, Chapel Hill

Study record dates

Study Major Dates

• Study Start: September 1, 2003
• Study Completion: October 1, 2006

Study Registration Dates

• First Submitted: September 19, 2005
• First Submitted That Met QC Criteria: September 19, 2005
• First Posted (Estimate): September 21, 2005

Study Record Updates

• Last Update Posted (Estimate): March 18, 2010
• Last Update Submitted That Met QC Criteria: March 17, 2010
• Last Verified: March 1, 2010

More Information

Terms related to this study

• Keywords: physical activity; obesity; cognitive behavior therapy; clinical trial; weight loss; outcomes research; questionnaire; Internet; human therapy evaluation; clinical research; human subject; self care; weight control; reinforcer; computer assisted patient care; behavioral /social science research tag; social support network; nutrient intake activity; personal log /diary
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: R03 DK60058 (completed 2007)