NCT05396443

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2022

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 25, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 31, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

August 15, 2022

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 6, 2025

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 8, 2025

Completed
Last Updated

February 3, 2026

Status Verified

January 1, 2026

Enrollment Period

2.5 years

First QC Date

May 25, 2022

Last Update Submit

January 30, 2026

Conditions

Obesity, ChildhoodType2Diabetes

Keywords

AdolescentsTelehealth Lifestyle ProgramDiabetes preventionBlack girlsObesity

Outcome Measures

Primary Outcomes (1)

  • Change in diet quality of adolescent participants, as measured by the Healthy Eating Index Scores

    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 Outcomes (12)

  • Change in dermal carotenoids level

    Baseline, 12 weeks [end of study]

  • Change in percent time sedentary

    Baseline, 12 weeks [end of study]

  • Change in percent time spent in light activity

    Baseline, 12 weeks [end of study]

  • Change in percent time spent in moderate to vigorous activity

    Baseline, 12 weeks [end of study]

  • Change in glucose levels

    Baseline, 12 weeks [end of study]

  • +7 more secondary outcomes

Study Arms (1)

Intervention Adolescents-Caregiver Dyads

EXPERIMENTAL

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

Interventions

Black Girls for Wellness TelehealthBEHAVIORAL

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 Adolescents-Caregiver Dyads

Eligibility Criteria

Age12 Years - 18 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Brooklyn Methodist Hospital

Brooklyn, New York, 11215, United States

Location

Weill Cornell Medicine

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Pediatric ObesityObesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Tashara M Leak, PhD, RD

    Weill Medical College of Cornell University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 25, 2022

First Posted

May 31, 2022

Study Start

August 15, 2022

Primary Completion

February 6, 2025

Study Completion

February 8, 2025

Last Updated

February 3, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

US(2)