In-person lifestyle program for Black adolescent girls at risk for type 2 diabetes
Examining the Preliminary Efficacy of an In-Person Lifestyle Intervention for Black Female Adolescent/Caregiver Dyads at Risk for Type 2 Diabetes Mellitus
NA · Cornell University · NCT06557317
This study tests if a 12-week in-person program can help Black adolescent girls and their caregivers improve their eating habits and activity levels to lower their risk of type 2 diabetes.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 12 Years to 18 Years |
| Sex | Female |
| Sponsor | Cornell University (other) |
| Locations | 1 site (Brooklyn, New York) |
| Trial ID | NCT06557317 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the impact of a 12-week in-person lifestyle program on diabetes-related risk factors in Black adolescent girls and their primary female caregivers. Participants will engage in weekly Wellness Sessions and at-home cooking experiences to improve diet quality and physical activity. The study will measure changes in diet, body composition, and glycemic levels before and after the program. The goal is to enhance overall health and reduce the risk of type 2 diabetes in this at-risk population.
Who should consider this trial
Good fit: Ideal candidates include Black adolescent girls aged 12-18 with obesity and their primary female caregivers who prepare most meals in the household.
Not a fit: Patients who are pregnant, have type 2 diabetes, or have conditions affecting metabolism or physical activity may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly reduce the risk of type 2 diabetes among Black adolescent girls and improve their overall health.
How similar studies have performed: Other studies focusing on lifestyle interventions for obesity and diabetes prevention in adolescents have shown promising results, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria for adolescent participants: * 12-18 years of age * self-identify as Black or African American * have obesity (\>=95th percentile BMI) Exclusion Criteria for adolescent participants: * pregnant or within 3 months postpartum. * participated in a formal weight management program within 6 months prior to study. * currently taking medications or diagnosed with a condition known to influence metabolism, physical activity ability, or cognitive function. * have previously undergone bariatric surgery. * have type 2 diabetes. * unable to speak English or have developmental conditions that interfere with ability to communicate. Inclusion Criteria for caregiver participants: * 18 years or older. * proficiency in speaking English. * live in the same household as the adolescent who will also be enrolled. * prepares the majority (\>50%) of meals in the household. Exclusion Criteria for caregiver participants: * pregnant or within 3 months postpartum. * unable to speak English or have developmental conditions that interfere with ability to communicate.
Where this trial is running
Brooklyn, New York
- Brownsville Neighborhood Health Action Center — Brooklyn, New York, United States (RECRUITING)
Study contacts
- Principal investigator: Tashara M Leak, PhD, RD — Cornell University
- Study coordinator: Tashara M Leak, PhD, RD
- Email: tml226@cornell.edu
- Phone: 607-255-7664
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Behavior, Adolescent, Childhood Obesity, Diabetes Mellitus, Type 2, Pediatric Obesity, Glucose Metabolism Disorders, Metabolic Disease, Endocrine System Diseases, Overweight