Evaluation of a SlimFast Internet Behavioral Weight Loss Program
Condition: Obesity
MeSH terms: Weight Loss
Study type: Interventional

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.
    

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.
    

Intervention name(s): Internet weight loss with SlimFast and human counseling; Internet weight loss with SlimFast and computer counseling; Internet weight loss program with SlimFast
Intervention type(s): Behavioral; Behavioral; Behavioral
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single
Primary purpose: Treatment
Keywords: Obesity; Weight loss; Internet