Diabetes Prevention Through Genetics, Familial History and Behavior Change

StatusNot Yet Recruiting
PhasePhase 2/3
Started

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Trial flagged as At Risk
Primary endpoint reworded 1 of 1 changed
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Record History

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  1. Notable Start date pushed from Nov 1, 2026 to Jan 1, 2027
    • Primary endpoint(s) modified
    • Secondary endpoints revised (15)
    • Eligibility criteria expanded, about 5 words
  2. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
The goal of this clinical trial is to learn if adding a family engagement component to the standard Diabetes Prevention Program (DPP) improves outcomes for adults with prediabetes. It will also learn about the effects of this approach on family members' health. The main questions it aims to answer are: * Does adding family health history collection and family participation to the DPP improve session attendance compared to standard DPP? * Does this family-centered approach lead to greater weight loss and HbA1c (blood sugar) reduction compared to standard DPP? * Do health improvements extend to participants' family members, and what factors explain differences in family-level outcomes? Researchers will compare an adapted DPP with a family component to the standard DPP (individual-focused) to see if involving family members improves diabetes prevention outcomes. Participants will: * Be assigned to one of two groups: adapted DPP with family sessions, or standard DPP * If assigned to the adapted DPP, complete a family health history using the Center for Disease Control and Prevention's (CDC) My Family Health Portrait tool and attend 6 additional sessions with family members focused on personalized risk communication * Attend regular checkups to measure weight and HbA1c at 6 and 12 months * Have session attendance tracked throughout the program * Family members of participants may also be asked to complete health assessments to measure any changes in their own health behaviors
Trial Details
NCT Number NCT07815236
Lead Sponsor Morehouse School of Medicine
Conditions
(from sponsor)
Prediabetes, Weight Loss
Related terms Diabetes Mellitus, Prediabetic State, Weight Loss
Enrollment 400 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov