NCT07441655

Brief Summary

This study will provide evidence for the utility of using a community-engaged research approach to implement a tailored, family-oriented adaptation of the Diabetes Prevention Program that will have positive effects on risk factors associated with type 2 diabetes morbidity and mortality among Black families in a Southwest Georgia community.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P25-P50 for not_applicable diabetes

Timeline
23mo left

Started Feb 2026

Typical duration for not_applicable diabetes

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 Progress16%
Feb 2026Apr 2028

Study Start

First participant enrolled

February 1, 2026

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

February 24, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 2, 2026

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2028

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2028

Last Updated

March 2, 2026

Status Verified

February 1, 2026

Enrollment Period

2.2 years

First QC Date

February 24, 2026

Last Update Submit

February 24, 2026

Conditions

Keywords

diabetesruraltype 2 diabetesnutritionphysical activitydiabetes preventionfamily researchfamily and householdchronic diseasesedentary behavior

Outcome Measures

Primary Outcomes (1)

  • Improvement in Weight

    Parents enrolled in the family intervention will demonstrate a 4% reduction in weight at the end of the intervention.

    10 months

Study Arms (1)

Families Implementing Good Health Traditions for Life

OTHER

Seven cohorts with a total of seventy families (10 families per cohort) will be enrolled in the study. Families will meet for weekly for 16 weeks and be administered child and adult specific curriculums to encourage healthy lifestyle changes. The adults will received the initial 16-week curriculum of the CDC's Diabetes Prevention Program, and the children will receive an aligned DPP-adapted curriculum.

Behavioral: Families Implementing Good Health Traditions for Life

Interventions

The 16-session weekly curriculum will have five components: 1) strategies for monitoring food intake and reducing calories; 2) identifying and controlling both personal and social cues for unhealthy eating behaviors; 3) the role of stress in unhealthy eating and relapse prevention; 4) strategies for monitoring and improving physical activity and sedentary behaviors; and 5) strategies to improve family support and cohesion. Parents and children will be divided into separate, 2-hour sessions most weeks. The sessions will be co-facilitated by trained CHWs and research staff members. As children of different ages will be participating, we will ensure enough staff are present to keep youth sessions well-coordinated in order to engage all ages. All sessions will be held in community locations convenient to the families, such as YMCAs, faith-based institutions, federally qualified health centers, etc.

Also known as: FIGHT of Life
Families Implementing Good Health Traditions for Life

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Family 1.a.) Black Parent/Guardian: age 18 years or older residing in the same household with child (i.e., biological or have legal guardianship for child) 1.b.) Child: age 8-15 years old
  • Parent/Guardian have HbA1c level 5.7-6.4% (prediabetes)
  • Parent/Guardian willing to commit to participation in a 20-month research study and have no plans to move from the area over the next 20-months
  • Parent/child are ambulatory and able to participate in physical activity

You may not qualify if:

  • Individuals with 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, or recent (\<12 months) cardiovascular events such as myocardial infarction or stroke;
  • Person taking medications that may affect endpoint analyses
  • Persons with co-morbid contraindications to physical activity or dietary changes.
  • Currently pregnant or planning to become pregnant in the next year.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Morehouse School of Medicine

Albany, Georgia, 31705, United States

RECRUITING

MeSH Terms

Conditions

Diabetes MellitusChronic DiseaseDiabetes Mellitus, Type 2Sedentary BehaviorMotor Activity

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBehavior

Central Study Contacts

Asia K Rivers, MPH

CONTACT

Rakale C Quarells, PhD

CONTACT

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

February 24, 2026

First Posted

March 2, 2026

Study Start

February 1, 2026

Primary Completion (Estimated)

March 31, 2028

Study Completion (Estimated)

April 30, 2028

Last Updated

March 2, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Individual Participant Data (IPD) collected during this study will not be shared with external researchers. The decision not to share IPD is based on considerations including participant confidentiality, informed consent limitations, and institutional data protection policies. All data will be reported in aggregate form in publications and presentations to ensure that no individual participant can be identified. Qualified researchers may contact the study sponsor or principal investigator with specific inquiries; however, access to raw individual-level data will not be provided.

Locations