Lifestyle Program for Type 2 Diabetes Risk in Black Adolescent Girls

(BGW In-Person Trial)

Overseen By Tashara M Leak, PhD, RD

Age: < 65

Sex: Female

Trial Phase: Academic

Sponsor: Cornell University

Must not be taking: Metabolism, Cognitive, Physical activity

Disqualifiers: Pregnancy, Bariatric surgery, Diabetes, others

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

Compensation: Varies

Number of Visits: 12

Duration: 12 weeks

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a 12-week lifestyle program, called Black Girls for Wellness In-Person, can change diabetes-related risk factors in Black adolescent girls at risk for type 2 diabetes and their primary female caregivers. The program includes wellness sessions, dance classes, and cooking experiences at home. It suits Black or African American girls aged 12-18 who have obesity. Participants should not be pregnant, have diabetes, or be on certain medications affecting metabolism or physical activity. Caregivers must live with the adolescent and prepare most of the household meals.

As an unphased study, this trial offers a unique opportunity to contribute to research that could improve wellness programs for Black adolescent girls and their families.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you are taking medications that affect metabolism, physical activity, or cognitive function, you may not be eligible to participate.

What prior data suggests that this lifestyle program is safe for Black adolescent girls?

Research shows that lifestyle programs for managing diabetes risk are generally safe and well-received. The Black Girls for Wellness In-Person program aims to help Black adolescent girls and their caregivers lower their diabetes risk through activities like wellness sessions, dance classes, and cooking experiences. Although specific safety data for this program is not available, similar programs, such as the Diabetes Prevention Program, have shown no major safety issues. These programs usually focus on lifestyle changes, which tend to have few risks. Since this trial does not involve medication, it is unlikely to cause health problems. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Black Girls for Wellness In-Person program because it offers a holistic and culturally tailored approach to reducing Type 2 diabetes risk in Black adolescent girls. Unlike standard treatments that typically focus on medication and dietary changes, this program includes engaging elements like dance classes and at-home cooking experiences, making healthy lifestyle changes more relatable and fun. By involving both adolescents and their caregivers in a 12-week program, it fosters a supportive environment, encouraging long-term healthy habits and family involvement. This unique approach could empower participants to take control of their health in a way that feels personal and sustainable.

What evidence suggests that this lifestyle program is effective for reducing type 2 diabetes risk in Black adolescent girls?

Research shows that lifestyle programs can help lower the risk of developing type 2 diabetes. One study found that these programs reduced diabetes cases by 59% in adults aged 45 to 59. This trial will evaluate the Black Girls for Wellness program, which aims to decrease the risk of diabetes in Black adolescent girls through lifestyle changes. Feedback from Black women has enhanced the effectiveness and cultural relevance of these programs. These findings suggest that similar programs could also benefit Black adolescent girls. ^{1 2 3 6 7}

Who Is on the Research Team?

Tashara M Leak, PhD, RD

Principal Investigator

Cornell University

Are You a Good Fit for This Trial?

This trial is for Black adolescent girls at risk for type 2 diabetes and their primary female caregivers. Participants will engage in a 12-week in-person lifestyle program designed to address diabetes-related risk factors.

Inclusion Criteria

Adolescent participants must self-identify as Black or African American

Caregiver participants must live in the same household as the enrolled adolescent

I prepare most of the meals at home.

Exclusion Criteria

I am a teenager and have not had weight loss surgery.

I am a teenager and I do not have type 2 diabetes.

I am not on medication nor have conditions affecting my metabolism, physical, or mental abilities.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in a 12-week in-person lifestyle program including Wellness Sessions, Dance Classes, and at-home Cooking Experiences

12 weeks

12 visits (in-person)

Follow-up

Participants are monitored for changes in diabetes-related risk factors such as diet quality, physical activity, and body composition

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Black Girls for Wellness In-Person

Trial Overview The study tests the effectiveness of the 'Black Girls for Wellness In-Person' program on reducing diabetes-related risk factors among participants through lifestyle changes over a period of 12 weeks.

How Is the Trial Designed?

Group I: Intervention Adolescent/Caregiver Dyads Experimental Treatment 1 Intervention

Adolescent/Caregiver dyads receive 12-week in-person lifestyle program consisting of a Wellness session, Dance Classes, and an at-home Cooking Experience.

Who Is Running the Clinical Trial?

Cornell University

Lead Sponsor

Trials

179

Recruited

14,090,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06557317

In-Person Lifestyle Program for Black Adolescent Girls at ... The aim of this study is to look at changes in diabetes-related risk factors in Black adolescent girls who are at risk for type 2 diabetes and their primary ...

2. trialx.com trialx.com/clinical-trials/listings/304127/in-person-lifestyle-program-for-black-adolescent-girls-at-risk-for-type-2-diabetes/?&radius=50

In-Person Lifestyle Program for Black Adolescent Girls at ... The aim of this study is to look at changes in diabetes-related risk factors in Black adolescent girls who are at risk for type 2 diabetes and ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5484429/

Black Women's Recommendations for Developing Effective ... The purpose of this study was to learn from 29 Black women how to develop effective Type 2 diabetes programming.

4. journals.sagepub.com journals.sagepub.com/doi/10.1177/20552076231173524

Diabetes prevention program outcomes by in-person ... Results showed a 59% reduction in the incidence of type 2 diabetes versus placebo for those 45 to 59 years and a 71% reduction for those ...

5. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2809969

Mobile Health Intervention in Patients With Type 2 Diabetes A clinical pharmacist and health coach–delivered mobile health intervention can improve blood glucose levels in African American and Latinx populations.

6. bwwla.org bwwla.org/programs/sistersinmotion/diabetes-prevention-program/

Diabetes Prevention Program (DPP) It helps people who are pre-diabetic and who are at high risk for developing type 2 diabetes prevent or delay the onset of the disease.

7. sciencedirect.com sciencedirect.com/science/article/pii/S2773065425000021

Advancing Equity in Diabetes Prevention for Both Black ... Both Black and Hispanic patients experience high rates of Type 2 diabetes and related health complications. Non-Hispanic Black women are 2.3 ...