Family Health Traditions for Type 2 Diabetes

(FIGHT for Life Trial)

Overseen By Rakale C Quarells, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Morehouse School of Medicine

Must not be taking: Endpoint affecting drugs

Disqualifiers: Severe psychological disorders, Diabetes, Congestive heart failure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 16

Duration: 16 weeks

70 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

Inclusion Criteria

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

I am able to walk and take part in physical activities.

Exclusion Criteria

I am taking medications that could affect the study results.

Persons with co-morbid contraindications to physical activity or dietary changes

Currently pregnant or planning to become pregnant in the next year

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Families participate in a 16-week tailored Diabetes Prevention Program with weekly sessions

16 weeks

16 visits (in-person)

Follow-up

Participants are monitored for weight reduction and other health indicators after the intervention

24 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Families Implementing Good Health Traditions for Life

How Is the Trial Designed?

Group I: Families Implementing Good Health Traditions for Life Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Morehouse School of Medicine

Lead Sponsor

Trials

22

Recruited

16,300+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Recruited

1,374,000+