NCT07808723

Brief Summary

The goal of this clinical trial is to determine whether a family-based lifestyle intervention reduces the risk of type 2 diabetes (T2D) among parents and their children. The intervention will also evaluate how well the program supports healthy lifestyle behaviors and family engagement. The primary outcome of this study is weight loss in parents. Researchers will evaluate changes in participants' weight and lifestyle behaviors before the study compared to the end of the study (12 weeks post intervention) and 3 months after participation in the program.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
17mo left

Started Aug 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress7%
Aug 2026Mar 2028

Study Start

First participant enrolled

August 29, 2026

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

September 2, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 9, 2026

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2028

Last Updated

September 18, 2026

Status Verified

September 1, 2026

Enrollment Period

1.5 years

First QC Date

September 2, 2026

Last Update Submit

September 15, 2026

Conditions

Weight ReductionPrediabetes

Keywords

Family-based diabetes prevention interventionCardiovascular Disease Prevention

Outcome Measures

Primary Outcomes (1)

  • Weight Reduction

    Weight at 12 weeks (post intervention) and three month follow up

    From enrollment to the end of intervention at 6 months

Study Arms (1)

Single arm pre/post study

EXPERIMENTAL
Behavioral: Family Diabetes Prevention

Interventions

Family Diabetes PreventionBEHAVIORAL

A weekly lifestyle modification program for families with at least one parent at high risk of developing diabetes.

Also known as: Family DPP+
Single arm pre/post study

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Parent/guardian must identify as African American or Hispanic
  • Parent/guardian must be 18+ years residing in the same household as the child (i.e., biological or have legal guardianship for child)
  • Parent/guardian must have prediabetes (HbA1c level 5.7-6.4%) or be at risk of developing Type 2 diabetes using CDC's Pre-Diabetes Risk Test
  • Participant is willing to commit to participation in a 12-week, in-person, intervention study
  • No plans to move over the next 9-months
  • Parent/guardian should be ambulatory and able to participate in physical activity
  • Children must be between the ages of 12-17 years old
  • Child should be ambulatory and able to participate in physical activity

You may not qualify if:

  • Severe psychological disorders that may prevent/interfere with study -participation
  • Physical impairments that may prevent participation in moderate intensity physical activity
  • Previous diagnosis of diabetes
  • History of congestive heart failure
  • Renal failure
  • Recent (\<12 months) cardiovascular events such as myocardial infarction (heart attack) or stroke
  • Taking medications that may affect endpoint analyses
  • Have co-morbid contraindications to physical activity or dietary changes
  • Currently pregnant or planning to become pregnant in the next year
  • Family lives outside of Georgia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Morehouse School of Medicine

Atlanta, Georgia, 30310, United States

RECRUITING

MeSH Terms

Conditions

Weight LossPrediabetic State

Condition Hierarchy (Ancestors)

Body Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Rakale C Quarells, PhD

    Morehouse School of Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Katrina M Brantley, DrPH

CONTACT

470-670-7840kbrantley@msm.edu

Danielle M Duvernay, MSHI

CONTACT

404-756-1224dduvernay@msm.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 2, 2026

First Posted

September 9, 2026

Study Start

August 29, 2026

Primary Completion (Estimated)

March 1, 2028

Study Completion (Estimated)

March 1, 2028

Last Updated

September 18, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will share

De-identified individual data will be shared with the NIH CEAL National Network.

Shared Documents
STUDY PROTOCOL
Time Frame
Data are shared with the NIH CEAL Network biannually.
Access Criteria
Members of the NIH CEAL Network will have access based on the data use agreements in place.
More information

Locations

US(1)