Evaluation of a SlimFast Internet Behavioral Weight Loss Program

This study has been completed.
Sponsor:
Information provided by:
The Miriam Hospital
ClinicalTrials.gov Identifier:
NCT00200304
First received: September 14, 2005
Last updated: April 23, 2013
Last verified: September 2005

September 14, 2005
April 23, 2013
January 2001
January 2003   (final data collection date for primary outcome measure)
Weight loss at 6 months
Same as current
Complete list of historical versions of study NCT00200304 on ClinicalTrials.gov Archive Site
Frequency of use of the Internet website
Same as current
Not Provided
Not Provided
 
Evaluation of a SlimFast Internet Behavioral Weight Loss Program
Development and Evaluation of a SlimFast Internet Behavioral Weight Loss Program

The Internet has been used effectively in behavioral weight loss programs. Most of these programs have involved a therapist who provides email counseling. The purpose of this study was to determine whether a computer-assisted weight loss program could be developed (that would use pre-programmed computer generated messages rather than human generated messages) and whether this program would be as effective as the therapist-assisted weight loss program.

Specific Aims Over 50% of Americans are overweight. These individuals are at increased risk of morbidity and mortality. Weight losses of 5-10% of body weight have been shown to lower these risks. The majority of individuals who lose weight do so on their own, without the help of formal programs. Developing ways to improve weight loss in such individuals is a major public health challenge. We believe that the Internet holds tremendous promise for reaching large numbers of overweight individuals and assisting them in their weight loss efforts. Our previous research has shown that a structured behavioral weight loss program offered via the Internet, with regular feedback from a therapist, can produce average weight losses of 9 lbs. at 6 months. The purpose of this project is to compare the weight losses achieved at 6 months using 3 different types of Internet programs, all of which are used in combination with SlimFast as the dietary component.Subject PopulationTwo hundred twenty-five overweight individuals will be recruited, aged 20-65 with a BMI of 27-40 who want to lose weight using SlimFast. Participants must be willing to attend an initial orientation and weigh-in session and follow-up weigh-in sessions and agree that they will not begin a second weight loss program within the next 12 months. Interested participants will be required to have access to a computer with Internet connection from their home or their workplace.Methods/DesignParticipants will be randomly assigned to one of three conditions: 1) SlimFast + Current SlimFast Website; 2) SlimFast + Current SlimFast Website + Computer-Generated E-mail feedback; or 3) SlimFast + Current SlimFast Website + Therapist-Assisted E-mail feedback. All 3 groups will be placed on a calorie-restricted diet (1200-1500 kcal/day) that utilizes SlimFast for 2 meals per day and a healthy evening meal. They will be encouraged to increase their exercise to 1000 kcal/week based on walking. Group 1 will receive all other input from the SlimFast website. Group 2 will receive weekly computer-generated feedback based on diet, physical activity and weight loss information. Group 3 will receive weekly e-mail messages from a trained therapist that will provide feedback based on diet, physical activity and weight loss information.Data AnalysisAll participants will be weighed at baseline, 3 months, and 6 months to document the weight changes they experience. The primary analysis will compare weight change from baseline to 6 months for the 3 conditions. An intent-to-treat analysis will be used, where dropouts are considered to have regained back to baseline weight. Secondary analyses will examine baseline predictors of weight loss and the association between use of the various Internet components and outcome.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind
Primary Purpose: Treatment
Obesity
  • Behavioral: Internet weight loss with SlimFast and human counseling
  • Behavioral: Internet weight loss with SlimFast and computer counseling
  • Behavioral: Internet weight loss program with SlimFast
Not Provided
Tate DF, Jackvony EH, Wing RR. A randomized trial comparing human e-mail counseling, computer-automated tailored counseling, and no counseling in an Internet weight loss program. Arch Intern Med. 2006 Aug 14-28;166(15):1620-5.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
225
January 2003
January 2003   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Overweight or obese

Exclusion Criteria:

  • heart disease
  • stroke
  • cancer
  • diabetes
  • orthopedic problems
  • pregnancy
Both
20 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00200304
2083-00
Not Provided
Not Provided
The Miriam Hospital
Not Provided
Principal Investigator: Rena R Wing, Ph.D. The Miriam Hospital
The Miriam Hospital
September 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP