Telehealth Lifestyle Program for Type 2 Diabetes Risk in Adolescents

No longer recruiting at 1 trial location

Overseen By Tashara M Leak, PhD, RD

Age: < 65

Sex: Female

Trial Phase: Academic

Sponsor: Weill Medical College of Cornell University

Must not be taking: Metabolism drugs

Disqualifiers: Pregnancy, Bariatric surgery, Type 2 diabetes, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a 12-week telehealth lifestyle program, called Black Girls for Wellness, can reduce type 2 diabetes risk factors in Black adolescent girls and their female caregivers. Participants will engage in online wellness sessions, cooking experiences, and dance classes. The trial seeks Black girls aged 12-18 with obesity and a female caregiver who lives with them and prepares most of the meals. As an unphased trial, this study provides a unique opportunity to contribute to important research that could benefit the community.

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 telehealth lifestyle program is safe for adolescents and their caregivers?

Research shows that lifestyle programs like Black Girls for Wellness are generally safe for participants. These programs help people adopt healthy habits, such as exercising and eating better, to lower the risk of diabetes. Studies have found that participants handle these programs well.

For online versions of these programs, like the one being tested, evidence also supports their safety. Past participants reported no major problems, suggesting a safe experience for both the girls and their caregivers.

Online lifestyle programs aim to help people live healthier lives. They do not involve taking medicine or undergoing medical procedures, which further reduces the risk of side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Telehealth Lifestyle Program for Type 2 Diabetes risk in adolescents because it offers a fresh approach by focusing on both adolescents and their caregivers in a holistic lifestyle intervention. Unlike traditional treatments that might center on medication or dietary changes alone, this program integrates wellness sessions, cooking experiences, and dance classes delivered through telehealth. This unique combination aims to foster healthier habits in a supportive environment, potentially leading to more sustainable lifestyle changes and better outcomes for managing diabetes risk.

What evidence suggests that this telehealth lifestyle program is effective for reducing type 2 diabetes risk in adolescents?

Research shows that diet and exercise can help lower the risk of type 2 diabetes. However, Black adolescent girls at risk for this condition often don't follow these guidelines. A small study found that programs like the Black Girls for Wellness initiative, which participants in this trial may receive, could help bridge this gap. Additionally, a mobile health program improved blood sugar levels in African American communities. These findings suggest that using telehealth to encourage healthy lifestyle changes might effectively reduce diabetes risk factors in Black adolescent girls and their families. ^{1 6 7 8 9}

Who Is on the Research Team?

Tashara M Leak, PhD, RD

Principal Investigator

Weill Medical College of Cornell University

Are You a Good Fit for This Trial?

This trial is for Black adolescent girls aged 12-18 with obesity, at risk for type 2 diabetes, and their caregivers. Girls must not be on metabolism-affecting meds or have conditions impacting metabolism or cognitive function. They also shouldn't be pregnant/postpartum recently, in a weight program recently, have communication issues due to developmental conditions, have type 2 diabetes already, or had bariatric surgery.

Inclusion Criteria

Caregiver participants must have proficiency in speaking English

Adolescent participants must self-identify as Black or African American

I am a teenager and I am obese.

Exclusion Criteria

Adolescent participants must not have participated in a formal weight management program within 6 months prior to the study

I am not on medication or diagnosed with a condition that affects my metabolism, physical activity, or thinking.

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

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 telehealth lifestyle program including Wellness Sessions, Cooking Experiences, and Dance Classes

12 weeks

Weekly virtual sessions

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
• Black Girls for Wellness Caregivers
• Control
• Control Caregivers

Trial Overview The study tests a telehealth lifestyle program tailored for Black adolescent girls at risk of developing type 2 diabetes. It involves the participants and their caregivers over a period of 12 weeks to observe changes in diabetes-related risk factors.

How Is the Trial Designed?

Group I: Intervention Adolescents-Caregiver Dyads Experimental Treatment 1 Intervention

Adolescent-caregiver dyads receive 12 week telehealth lifestyle program consisting of a Wellness session, Cooking Experience, and Dance Classes.

Who Is Running the Clinical Trial?

Weill Medical College of Cornell University

Lead Sponsor

Trials

1,103

Recruited

1,157,000+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Recruited

1,374,000+

Cornell University

Collaborator

Trials

179

Recruited

14,090,000+

Citations

1. reporter.nih.gov reporter.nih.gov/search/14E9CE024F8FC5D27598B8961CAA4A01A2FFCEB861BF/project-details/10552602

a pilot randomized controlled trial Diet and physical activity are shown to reduce T2DM risk, but Black adolescent girls with T2DM are not meeting recommendations for either. Lifestyle ...

2. 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 ...

3. 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.

4. researchgate.net researchgate.net/publication/369156727_Effectiveness_of_an_immersive_telemedicine_platform_for_delivering_diabetes_medical_group_visits_for_African_American_Black_and_Hispanic_Latina_women_with_uncontrolled_diabetes_The_Women_in_Control_20

(PDF) Effectiveness of an immersive telemedicine platform ... Secondary outcomes included changes in diabetes distress and depressive symptoms. Results: Of 309 female participants (mean age 55, SD 10.6 ...

5. publichealth.jmir.org publichealth.jmir.org/2022/2/e25890/

Effectiveness of Mobile Phone and Web-Based Interventions ... This paper reviews the evidence for mHealth and web-based interventions for diabetes and obesity in African American and Hispanic adults.

6. pediatrics.weill.cornell.edu pediatrics.weill.cornell.edu/news/taking-action-adolescents-prediabetes-lifestyle-interventions

Taking Action for Adolescents with Prediabetes: Lifestyle ... The Black Girls for Wellness Program is enrolling Black adolescent girls who have a body mass index >95th percentile, as well as a female ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6125024/

Lifestyle and the Prevention of Type 2 Diabetes: A Status ... In the IDPP, participants randomized to receive monthly in-person advice on physical activity and diet to prevent diabetes achieved a 28.5% relative risk ...

8. cms.gov cms.gov/files/document/culturally-and-linguistically-tailored-type-2-diabetes-prevention-resource.pdf

Diabetes Prevention Programs: Equity Tailored Resources Below, we summarize key strategies researchers used when developing materials and programs to address type 2 diabetes risk factors among minority populations. ...

9. telehealthcoe.org telehealthcoe.org/wp-content/uploads/2023/10/Implementation-of-a-Telehealth-Lifestyle-Intervention-to-Prevent-Diabetes-in-Black-Parent%E2%80%90Child-Dyads.pdf

Implementation-of-a-Telehealth-Lifestyle-Intervention-to- ... Background: Obesity and family history increase the risk for youth‐onset type 2 diabetes mellitus (T2DM) disproportionately in Black youth. Critical ...