Telehealth Lifestyle Program for Black Adolescent Girls at Risk for Type 2 Diabetes

January 30, 2026 updated by: Cornell University

A Telehealth Lifestyle Intervention for Black Adolescent Girls at Risk for Type 2 Diabetes: A Pilot Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Enrolled adolescent/caregiver dyads will participate in the 12-week program. Each week, participants will engage in 2 activities: a live virtual Wellness Session and an at-home cooking experience using ingredients sent to them via grocery delivery service.

The study will examine the pre-post difference in overall diet quality, dermal carotenoid levels, physical activity, body composition, and glycemic measures among at-risk black adolescent girls and their caregivers. Investigators hypothesize that after the program, participants' diets will be higher in quality than before.

Study Type

Interventional

Enrollment (Actual)

19

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Brooklyn, New York, United States, 11215
        • Brooklyn Methodist Hospital
      • New York, New York, United States, 10021
        • Weill Cornell Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria for adolescent participants:

  • 12-18 years of age
  • self-identify as Black or African American
  • have obesity

Exclusion Criteria of 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 of 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 of caregiver participants:

  • pregnant or within 3 months postpartum.
  • unable to speak English or have developmental conditions that interfere with ability to communicate.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Adolescents-Caregiver Dyads
Adolescent-caregiver dyads receive 12 week telehealth lifestyle program consisting of a Wellness session, Cooking Experience, and Dance Classes.
Behavioral: Black Girls for Wellness Telehealth
Weekly for 12 weeks, adolescent-caregiver dyads will attend 1) a live stream group Wellness (mindfulness, nutrition lesson, dance class, program reflection) session (90 min/wk) and 2) a home cooking experience using ingredients sent to participants' homes (60 min/wk) with their caregiver. Others in the home (e.g., siblings) will be encouraged to participate in activities as well.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in diet quality of adolescent participants, as measured by the Healthy Eating Index Scores
Time Frame: Baseline, 12 weeks [end of study]
Scores are calculated from three 24-hour diet records, range from 0-100. Higher score reflects that higher alignment between one's diet and dietary recommendations from the Dietary Guidelines for Americans.
Baseline, 12 weeks [end of study]

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in dermal carotenoids level
Time Frame: Baseline, 12 weeks [end of study]
Scores are measured using the Veggie Meter device, range from 0-800. Higher score acts as proxy for fruits and vegetables consumption.
Baseline, 12 weeks [end of study]
Change in percent time sedentary
Time Frame: Baseline, 12 weeks [end of study]
Accelerometry data will be collected from wrist accelerometers worn by participants for 7 days. Percent time spent on sedentary will be calculated.
Baseline, 12 weeks [end of study]
Change in percent time spent in light activity
Time Frame: Baseline, 12 weeks [end of study]
Accelerometry data will be collected from wrist accelerometers worn by participants for 7 days. Percent time spent in light activity will be calculated.
Baseline, 12 weeks [end of study]
Change in percent time spent in moderate to vigorous activity
Time Frame: Baseline, 12 weeks [end of study]
Accelerometry data will be collected from wrist accelerometers worn by participants for 7 days. Percent time spent in moderate and vigorous activity will be calculated.
Baseline, 12 weeks [end of study]
Change in body mass index
Time Frame: Baseline, 12 weeks [end of study]
Height will be measured using a stadiometer to the nearest decimal point in cm. Weight will be measured using a scale to the nearest decimal in kg. Body mass index will be calculated using kg/m^2.
Baseline, 12 weeks [end of study]
Change in body fat percentage
Time Frame: Baseline, 12 weeks [end of study]
Body fat percentage will be measured using a scale to the nearest decimal.
Baseline, 12 weeks [end of study]
Change in waist circumference
Time Frame: Baseline, 12 weeks [end of study]
Waist circumference will be measured using a waist circumference tape to the nearest decimal in cm.
Baseline, 12 weeks [end of study]
Change in high blood pressure status
Time Frame: Baseline, 12 weeks [end of study]
Blood pressure will be measured using blood pressure monitors. High blood pressure is considered as reading of >=120/80.
Baseline, 12 weeks [end of study]
Change in glucose levels
Time Frame: Baseline, 12 weeks [end of study]

Fasting glucose and 2 hour glucose levels will be collected through an oral glucose tolerance test.

Subjects enrolled after May 13 2024 will not complete this test to address recruitment barriers (e.g., availability/ time needed for 2 hour test).
Baseline, 12 weeks [end of study]
Change in fasting insulin levels
Time Frame: Baseline, 12 weeks [end of study]

Insulin level will be assessed through blood draws on fasting participants.

Subjects enrolled after May 13 2024 will not be required to fast for this test to address recruitment barriers (e.g., availability for morning appointment) and reduce participant burden.
Baseline, 12 weeks [end of study]
Change in HbA1c
Time Frame: Baseline, 12 weeks [end of study]

HbA1c will be assessed through blood draws on fasting participants.

Subjects enrolled after May 13 2024 will not be required to fast for this test to address recruitment barriers (e.g., availability for morning appointment) and reduce participant burden.
Baseline, 12 weeks [end of study]
Change in lipid profile
Time Frame: Baseline, 12 weeks [end of study]

Total, high-density, low-density cholesterol, and triglycerides will be assessed through blood draws on fasting participants.

Subjects enrolled after May 13 2024 will not be required to fast for this test to address recruitment barriers (e.g., availability for morning appointment) and reduce participant burden.
Baseline, 12 weeks [end of study]

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cornell University

Collaborators

National Institute on Minority Health and Health Disparities (NIMHD)
Weill Medical College of Cornell University

Investigators

  • Principal Investigator: Tashara M Leak, PhD, RD, Weill Medical College of Cornell University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 15, 2022

Primary Completion (Actual)

February 6, 2025

Study Completion (Actual)

February 8, 2025

Study Registration Dates

First Submitted

May 25, 2022

First Submitted That Met QC Criteria

May 25, 2022

First Posted (Actual)

May 31, 2022

Study Record Updates

Last Update Posted (Actual)

February 3, 2026

Last Update Submitted That Met QC Criteria

January 30, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21-04023546
  • 1R21MD016986-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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