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Evaluation of a SlimFast Internet Behavioral Weight Loss Program

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00200304
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : April 24, 2013
Information provided by:
The Miriam Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
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 Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 225 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: Development and Evaluation of a SlimFast Internet Behavioral Weight Loss Program
Study Start Date : January 2001
Actual Primary Completion Date : January 2003
Actual Study Completion Date : January 2003

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Weight loss at 6 months

Secondary Outcome Measures :
  1. Frequency of use of the Internet website

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Overweight or obese

Exclusion Criteria:

  • heart disease
  • stroke
  • cancer
  • diabetes
  • orthopedic problems
  • pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00200304

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United States, Rhode Island
The Miriam Hospital
Providence, Rhode Island, United States, 02903
Sponsors and Collaborators
The Miriam Hospital
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Principal Investigator: Rena R Wing, Ph.D. The Miriam Hospital
Publications of Results:
Layout table for additonal information Identifier: NCT00200304    
Other Study ID Numbers: 2083-00
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: April 24, 2013
Last Verified: September 2005
Keywords provided by The Miriam Hospital:
Weight loss
Additional relevant MeSH terms:
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Weight Loss
Body Weight
Body Weight Changes