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

NCT ID: NCT05396443

Last Updated: 2026-02-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-15

Study Completion Date

2025-02-08

Brief Summary

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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

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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.

Conditions

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Obesity, Childhood Type2Diabetes

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Intervention Adolescents-Caregiver Dyads

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

Group Type EXPERIMENTAL

Black Girls for Wellness Telehealth

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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


* 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

* 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.


* pregnant or within 3 months postpartum.
* unable to speak English or have developmental conditions that interfere with ability to communicate.
Minimum Eligible Age

12 Years

Maximum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Weill Medical College of Cornell University

OTHER

Sponsor Role collaborator

National Institute on Minority Health and Health Disparities (NIMHD)

NIH

Sponsor Role collaborator

Cornell University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tashara M Leak, PhD, RD

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Locations

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Brooklyn Methodist Hospital

Brooklyn, New York, United States

Site Status

Weill Cornell Medicine

New York, New York, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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1R21MD016986-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

21-04023546

Identifier Type: -

Identifier Source: org_study_id

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