Diabetes Mellitus Clinical Trial
Official title:
Family Diabetes Study (Family PALS (PArtners in Lifestyle Support)
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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