Telehealth Lifestyle Program for Type 2 Diabetes Risk in Adolescents

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

19 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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 female caregiver after both participating in a 12-week telehealth lifestyle program.

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+