Diabetes Prevention Through Genetics, Familial History and Behavior Change

NCT07815236 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: 1R01MD021606
• Study Type: interventional
• Target: 400
• Locations: 0 countries
• Sites: N/A

Brief 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 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

Conditions

Prediabetes; Weight Loss

Keywords

Prediabetic State; Diabetes Mellitus, Type 2, Prevention and Control; Family Health; Health Status Disparities; Rural Health

Outcome Measures

Primary Outcomes (1)

• Percent change in body weight

  Body weight (kg) expressed as a continuous variable will be collected on a digital scale.

  Baseline, 6 months, 12 months

Secondary Outcomes (15)

• Mean Change in Blood Pressure

  Baseline, 6 months, 12 months

• Change in HbA1c (fasting, CLIA-waived assay)

  Baseline, 6 months, 12 months

• Change in Fasting lipid panel (total cholesterol, HDL, LDL, triglycerides)

  Baseline, 6 months, 12 months

• Change in Skin carotenoids

  Baseline, 6 months, 12 months

• Change in Physical activity steps

  Baseline, 6 months, 12 months

Study Arms (2)

Lifestyle Engagement through Genetics and Collaborative familY DPP (LEGACY DPP)

EXPERIMENTAL

Participants will receive the LEGACY DPP intervention

Behavioral: LEGACY DPP

Diabetes Prevention Program (DPP)

ACTIVE COMPARATOR

Participants will receive the DPP intervention

Behavioral: DPP

Interventions

LEGACY DPP BEHAVIORAL

The 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

Lifestyle Engagement through Genetics and Collaborative familY DPP (LEGACY DPP)

DPP BEHAVIORAL

The index partner will participate in standard DPP Participants will receive \- core behavioral weight loss group sessions

Diabetes Prevention Program (DPP)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Has an adult household/family or framily (fictive kin) member willing to enroll as a paired participant.
• Willing to attend in-person sessions

You may not qualify if:

• Minors \<18 years
• Prior diagnosis of T1 or T2D.
• HbA1c ≥6.5% at screening (Aim 1/2 curriculum eligibility)
• Current glucose-lowering medication use
• Pregnancy
• Physical-activity contraindications
• Individuals unable to speak or understand English

Sponsors & Collaborators

• Morehouse School of Medicine: lead

MeSH Terms

Conditions

Prediabetic State; Weight Loss; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Candice L Alick, PhD

  Morehouse School of Medicine

  PRINCIPAL INVESTIGATOR

• Tennille Leak-Johnson, PhD

  Morehouse School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Candice L Alick, PhD

CONTACT

404-752-1009; calick@msm.edu

Tennille Leak-Johnson, PhD

CONTACT

404-756-5225; tleakjohnson@msm.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 6, 2026
• First Posted: September 11, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): January 31, 2031
• Study Completion (Estimated): January 31, 2031
• Last Updated: September 11, 2026

Record last verified: 2026-09