Keep It Off: A Weight Loss Maintenance Study
Condition: Weight Loss Maintenance
MeSH terms: Body Weight; Weight Loss
Study type: Interventional

Summary: 
      The goal of this project is to test whether a phone and mail-based program designed to help
      people who have recently lost weight helps them keep the weight off over a 2 year period.
    

Detailed description: 
      Obesity is a major public health problem in the United States. Increases in obesity
      prevalence over the last four decades have been dramatic in all age and social groups,
      heightening concern about health risks for children, adolescents, and adults. Currently, over
      half of US adults are overweight and upward trends in prevalence show no sign of slowing. A
      continuation of current trends seems quite likely to lead to substantial increases in the
      number of people affected by obesity-related health conditions and in premature mortality.
      The primary treatment for obesity continues to be behavioral weight loss therapy, an approach
      that uses behavioral strategies (e.g., self-monitoring, stimulus control, problem-solving) to
      help participants adhere to dietary and physical activity recommendations. Significant
      progress has been made with respect to short term weight loss research over the past twenty
      years, with short term weight losses approximately doubling during this time period.
      Unfortunately, long term weight losses remain disappointing. The typical pattern is for
      maximum weight loss to occur at 6 months, with weight regain following. During the year
      following treatment, participants typically regain 30% to 50% of their initial weight loss.
      Follow-up beyond 1 year indicates a pattern of continued weight gain.

      Though long term weight loss maintenance remains a critical challenge for obesity treatment,
      important information regarding successful weight loss maintenance (e.g., high levels of
      physical activity, self-weighing, maintenance of a low-fat, low-calorie diet) has been
      derived from the National Weight Control Registry led by Drs Wing and Hill. Treatment studies
      have incorporated such strategies to enhance maintenance; however, the most intensive
      treatment phase typically occurs during weight loss initiation with the maintenance phase
      occurring after treatment novelty has faded. Although increasing treatment duration improves
      weight loss, there is a point of diminishing returns as people eventually stop attending
      intervention sessions. An alternative strategy to provide the critical support necessary for
      weight loss maintenance may be to recruit people who have recently lost weight to a
      maintenance-focused intervention

      We will recruit up to 400 adult men and women who have recently lost at least 10% of their
      body weight and randomize them to either a Self-Directed Intervention or a Guided
      Intervention . Self- Directed participants will receive a core set of print materials
      describing key behaviors and skills necessary for successful weight loss maintenance and will
      review these materials with an intervention coach during two phone sessions. Guided
      participants will take part in a set of ten core phone sessions addressing key factors
      relevant to weight maintenance (e.g., high levels of physical activity). After completing
      these sessions, Guided participants will receive 8 monthly check in calls and then bimonthly
      calls for the rest of the study. Guided participants are also asked to report their weight
      weekly, either via the Keep It Off website, email or voicemail. Those who experience weight
      gain will receive outreach calls to assist them in reversing their recent weight gain. They
      will also receive bi-monthly tailored feedback reports based on whether they are maintaining,
      losing or gaining weight. We hypothesize that those in the Guided arm of the study will
      regain less weight than those in the self-directed arm.
    

Intervention name(s): Self-Directed (weight loss maintenance); Guided (weight loss maintenance)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Self- Directed participants will receive a core set of print materials describing key behaviors and skills necessary for successful weight loss maintenance and will review these materials with an intervention coach in two sessions.; Guided participants will receive 8 monthly check in calls and then bimonthly calls for the rest of the study. Guided participants are also asked to report their weight weekly, either via the Keep It Off website, email or voicemail. Those who experience weight gain will receive outreach calls to assist them in reversing their weight gain.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Weight loss maintenance.; Interactive phone and mail-based intervention.