Diabetes Prevention Through Genetics, Familial History and Behavior Change
Trial statusNot yet recruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorMorehouse School of Medicine
About this trial
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 CDC's 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
This trial accepts healthy volunteersQualifiers
Age ≥18 years.
Fasting HbA1c 5.7-6.4% confirmed by CLIA-waived point-of-care testing.
BMI ≥25 kg/m².
Able to provide informed consent.
Disqualifiers
Minors <18 years
Prior diagnosis of T1 or T2D.
HbA1c ≥6.5% at screening (Aim 1/2 curriculum eligibility)
Current glucose-lowering medication use
Trial design
Design model
Parallel
Treatments tested in this trial
LEGACY DPP
BehavioralThe index partner will participate in an adapted DPP as a dyad with a family member with family health history and family participation and skill building Participants will receive * family health history sessions * core behavioral weight loss group sessions * a family skill building segment covering cohesion and communication during core sessions
DPP
BehavioralThe index partner will participate in standard DPP Participants will receive \- core behavioral weight loss group sessions
Treatment groups
400 Participants
are divided into 2 treatment groupsGroup A: Lifestyle Engagement through Genetics and Collaborative familY DPP (LEGACY DPP)Experimental treatment 1 intervention
Group B: Diabetes Prevention Program (DPP)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Percent change in body weight
Body weight (kg) expressed as a continuous variable will be collected on a digital scale.
Time frame
Baseline, 6 months, 12 monthsSecondary outcomes
1
Mean Change in Blood Pressure
Blood Pressure measured after 5 minutes of rest and taken in the same position throughout the study.
Time frame
Baseline, 6 months, 12 months2
Change in HbA1c (fasting, CLIA-waived assay)
Blood (\~20 mL) will be collected to assess changes in glycosloated hemoglobin
Time frame
Baseline, 6 months, 12 months3
Change in Fasting lipid panel (total cholesterol, HDL, LDL, triglycerides)
Fasting lipid panel will measured to assess changes in total cholesterol, HDL, LDL, and triglycerides.
Time frame
Baseline, 6 months, 12 months4
Change in Skin carotenoids
Skin carotenoids will be assessed using a VeggieMeter as an indicator for fruit and vegetable intake.
Time frame
Baseline, 6 months, 12 monthsLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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