Family PALS (PArtners in Lifestyle Support)
Condition: Diabetes Mellitus
Study type: Interventional

Summary: 
      NOTE: This study is in the trial-phase of a 5-year study that included a formative research
      phase (Phase 1 - IRB study # 07-1765 "Family-based Diabetes Self-management Training for
      African American Adults"). During the first phase, eight focus groups were conducted with 68
      participants and a validation study with 215 African American patients with type 2 diabetes.
      The data gathered in Phase 1 informs the refinement of the intervention in this phase.

      Purpose: The overall goal of this research is to evaluate, in a randomized controlled trial,
      a family-based diabetes self-management intervention for overweight/obese African American
      adults with type 2 diabetes (the "index participants") and a paired overweight family member
      (co-participant) who does not have diabetes. The primary outcome is weight change in the
      index participant.
    

Detailed description: 
      Type 2 diabetes disproportionately burdens African Americans, and already excessive rates of
      diabetes are expected to increase even further as rates of obesity rise. While there is
      evidence that diabetes self-management training is effective in improving metabolic control,
      and modest weight loss can delay the onset of diabetes, the investigators have limited
      knowledge of the best approach to self-management training from a family perspective in high
      risk groups such as African Americans. Family remains a valued dimension of African American
      life and may be an important behavioral context for interventions to improve disease
      management and health outcomes. Nonetheless, there are no trials of family-based
      interventions to improve diabetes self-care and achieve weight loss that have involved adult
      families.

      Participants: A total of 80 pairs (index participant + family member) or 160 adults will
      participate in this trial where a 20-session behavioral weight loss intervention will be
      tested. Participants include overweight or obese African Americans with type 2 diabetes and a
      paired co-participant identified as an overweight or obese adult family member without type 2
      diabetes. Family members may self-describe as non-African Americans.

      Procedures (methods): Study participants will be enrolled in a randomized controlled trial
      using a 2:1 random allocation to the special intervention (a 20-session family-based
      behavioral weight loss intervention) or a usual care group (controls). Following the trial,
      participants in the usual care group will receive a 6-session weight management intervention
      (over a 2-month period) based on the 20-session special intervention.
    

Intervention name(s): Adult diabetes family-based weight loss intervention
Intervention type(s): Behavioral
Intervention description(s): Participants assigned to the experimental group will begin the 2o-week weight loss intervention, while delayed intervention controls will wait until the end of this period to begin their program. The weight loss intervention includes 20 weekly group-based sessions facilitated by a registered dietitian. Each group session will last about 120 minutes and include: weight check, group sharing and problem-solving, discussion of a weight control topics (nutrition, physical activity, or behavior change), physical activity and/or taste-testing. Ten sessions will include a brief component, focused on improving family relationships for better diabetes self-care. The study weight loss goal is ≥10 pounds (minimum rate-0.5 lb/week; maximum-2 lbs/week). While the control group waits, they will receive 1 newsletter with study updates and general health or diabetes information. The delayed intervention includes 6 sessions (4 weekly + 2 bi-weekly) following the same format as the experimental group.
Other intervention name(s): intense weight loss intervention; family-based lifestyle intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment