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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05396443
Enrollment
19
Registered
2022-05-31
Start date
2022-08-15
Completion date
2025-02-08
Last updated
2026-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Childhood, Type2Diabetes

Keywords

Adolescents, Telehealth Lifestyle Program, Diabetes prevention, Black girls, Obesity

Brief summary

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.

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.

Interventions

BEHAVIORALBlack 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.

Sponsors

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

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
12 Years to 18 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in diet quality of adolescent participants, as measured by the Healthy Eating Index ScoresBaseline, 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.

Secondary

MeasureTime frameDescription
Change in body fat percentageBaseline, 12 weeks [end of study]Body fat percentage will be measured using a scale to the nearest decimal.
Change in dermal carotenoids levelBaseline, 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.
Change in percent time sedentaryBaseline, 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.
Change in percent time spent in light activityBaseline, 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.
Change in percent time spent in moderate to vigorous activityBaseline, 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.
Change in glucose levelsBaseline, 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).
Change in fasting insulin levelsBaseline, 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.
Change in HbA1cBaseline, 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.
Change in lipid profileBaseline, 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.
Change in waist circumferenceBaseline, 12 weeks [end of study]Waist circumference will be measured using a waist circumference tape to the nearest decimal in cm.
Change in body mass indexBaseline, 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.
Change in high blood pressure statusBaseline, 12 weeks [end of study]Blood pressure will be measured using blood pressure monitors. High blood pressure is considered as reading of \>=120/80.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORTashara M Leak, PhD, RD

Weill Medical College of Cornell University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026