Recruiting

Diabetes Prevention Program

Sponsor:

Morehouse School of Medicine

Code:

NCT07441655

Conditions

Diabetes

Chronic Disease

Type 2 Diabetes

Healthy Lifestyle

Nutrition, Healthy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Families Implementing Good Health Traditions for Life

Study Details

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.

Conditions

Diabetes

Chronic Disease

Type 2 Diabetes

Healthy Lifestyle

Nutrition, Healthy

Study ID

NCT07441655

Start date

Feb 1, 2026

Status verified date

Jun, 2026

Completion date

Jul 31, 2028

Anticipated

Primary completion date

Mar 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. 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
2. Parent/Guardian have HbA1c level 5.7-6.4% (prediabetes)
3. 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
4. Parent/child are ambulatory and able to participate in physical activity

Exclusion Criteria:

1. Individuals with severe psychological disorders that may prevent/interfere with study participation
2. Physical impairments that may prevent participation in moderate intensity physical activity;
3. Previous diagnosis of diabetes
4. History of congestive heart failure, renal failure, or recent (<12 months) cardiovascular events such as myocardial infarction or stroke;
5. Person taking medications that may affect endpoint analyses
6. Persons with co-morbid contraindications to physical activity or dietary changes.
7. Currently pregnant or planning to become pregnant in the next year.

Study Design

Enrollment

70 participants

Anticipated

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

other: Families Implementing Good Health Traditions for Life

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.

Interventions

Families Implementing Good Health Traditions for Life

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, enough staff will be 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.

Primary outcome measure

  • Change in weight from baseline to post-intervention at 4 months [ Time Frame: 4 months ]

Central Contacts and Locations

Central contacts

Locations

Morehouse School of Medicine

Recruiting

Albany, Georgia, United States, 31705

Contacts

More Information

Sponsor

Morehouse School of Medicine

Last update posted

Aug 5, 2026

Last verified

Jun, 2026

Keywords

  • diabetes
  • rural
  • type 2 diabetes
  • nutrition
  • physical activity
  • diabetes prevention
  • family research
  • family and household
  • chronic disease
  • sedentary behavior

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Morehouse School of Medicine on 2026-08-05.