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Not Yet Recruiting NCT07815236

Diabetes Prevention Through Genetics, Familial History and Behavior Change

Conditions: Prediabetes, Weight Loss

Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: Yes
Phase: PHASE2, PHASE3
Enrollment: 400
Sponsor: Morehouse School of Medicine

Summary

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

Eligibility Criteria

Inclusion Criteria: * Age ≥18 years. * Fasting HbA1c 5.7-6.4% confirmed by CLIA-waived point-of-care testing. * Body Mass Index ≥25 kg/m². * Able to provide informed consent. * Has an adult household/family or framily (fictive kin) member willing to enroll as a paired participant. * Willing to attend in-person sessions Exclusion Criteria: * Minors \

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07815236). StuddyBuddy aggregates publicly available trial information.