Efficacy of a Web-based Tailored Weight Management Program
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The primary objective of this study is to assess the benefit of using online, tailored
      behavioral weight management materials (Balance), in combination with nutritional materials
      (Balance and Nourish), in conjunction with a goal setting tool (Balance and Achieve), or a
      combination of all three (Balance, Nourish and Achieve). This objective will be evaluated by
      measuring weight loss rates as reported by study participants at 3, 12, and 18 months
      post-enrollment. The hypothesis is that adding additional materials will increase the effect
      of the intervention over just using Balance alone.
    

Detailed description: 
      This will be a randomized control, web-based trial for weight management with four treatment
      arms. Participants will be assigned to receive tailored materials from either: 1) the Balance
      program, 2) the Balance and Nourish programs, 3) the Balance and Achieve programs, or 4) the
      Balance, Nourish and Achieve programs. Participants will be recruited directly through their
      health care organization. In order to participate, participants must visit the website to
      confirm their eligibility, e.g. valid e-mail address. Those who wish to participate will
      provide consent on the Web, and then will be presented with an online questionnaire. These
      questions will provide baseline data for each participant and will be the basis for the
      tailoring of the Balance materials each participant will receive. Within 24 hours of
      submitting the completed questionnaire, participants will be informed by e-mail that their
      tailored Balance plan is available on the website. They will receive follow-up materials by
      e-mail during the six-week period after they enroll. Participants who have been assigned to
      additional programs will be sent e-mails with links to the relevant programs. At 3, 12 and 18
      months, all participants will be assessed via an online survey. The assessment will include
      weight management parameters, psychosocial outcomes, and program utilization. This data will
      be self-reported.

      STUDY POPULATION The study sample will be drawn from members of three integrated delivery
      systems: Kaiser Permanente Colorado (KPCO), Kaiser Permanente Ohio (KPOH), and Group Health
      Cooperative (GHC) of Puget Sound. In order to participate, participants must access and
      enroll in the study on the Web. A total of 1,848 participants will be enrolled within a
      six-month period, with approximately 450 participants in each treatment arm. By 18-month
      follow-up, we assume successful data collection from at least 65 percent of the enrollees, or
      1200 participants, 300 in each treatment group. The study is open to those who meet the
      inclusion and exclusion criteria.
    

Intervention name(s): tailored web-based weight management intervention
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single
Keywords: tailored; web-based; weight management; obesity; efficacy