Adaptation of the Diabetes Prevention Program for Primary Care
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      The study has two primary aims. The first aim is to assess the efficacy of adding in-person
      visits to the use of portion-controlled foods for long-term weight loss. The second aim is to
      assess the use of trained lay counselors for the maintenance of weight loss. The primary
      endpoint of the study will be changes in weight. Secondary endpoints will include changes in
      body mass index (BMI), cardiovascular risk factors, health-related quality of life, and
      cost-effectiveness. The addition of in-person visits with the weight loss counselor is
      predicted to lead to greater long-term weight loss than the use of portion-controlled foods
      alone.
    

Detailed description: 
      This study will be a randomized trial of a weight control intervention, with participants
      recruited primarily from primary care practices at the University of Colorado. Study
      treatment will be delivered at the Center for Human Nutrition, an inter-disciplinary research
      clinic which is part of the University of Colorado School of Medicine. If needed,
      administrative study visits, such as for informed consent and for completion of
      questionnaires, may take place at offices in the Division of General Internal Medicine. Up to
      200 patients will be enrolled, of which up to 125 will be provided with 6 months of
      high-intensity weight loss counseling. During the first 6 months, each participant will be
      seen for 12 counseling visits. These visits will take place at weeks 1, 2, 3, 4, 6, 8, 10,
      12, 15, 18, 21, and 24. We estimate that between 10% and 20% of these patients will drop out
      prior to 6 months. After the first 6 months, the remaining participants will be randomly
      assigned to a treatment condition: Standard Maintenance or Intensified Maintenance. During
      months 7 to 18, individuals in the Standard Maintenance condition will receive informational
      handouts by mail (or e-mail) regarding weight maintenance, while those in the Intensified
      Maintenance condition will continue to have monthly in-person visits with the weight loss
      counselor ("Weight Coach").

      All participants will use portion-controlled foods to replace 2 meals per day during the
      first 6 months of treatment and to replace 1 meal per day during months 7 to 18. Participants
      will purchase their own portion-controlled foods, although in-kind contributions from private
      industry will be sought to offset participants' food costs. The study consent form will
      explicitly describe estimated food costs for study participants. The cost of the meal plan, a
      "partial meal replacement" diet (replacement of 2 out of 3 meals per day) is not expected to
      increase food costs. Many participants should observe a decrease in food costs while
      following the meal plan.
    

Intervention name(s): Standard maintenance; Intensified maintenance
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants will receive written materials in months 7-18; Participants will continue with in-person counseling visits in months 7-18
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: obesity; weight loss