Recruiting

Lifestyle Program

Sponsor:

Cornell University

Code:

NCT06557317

Conditions

Behavior, Adolescent

Childhood Obesity

Diabetes Mellitus, Type 2

Pediatric Obesity

Glucose Metabolism Disorders

Eligibility Criteria

Sex: Female

Age: 12 - 18

Healthy Volunteers: Not accepted

Interventions

Black Girls for Wellness In-Person

Study Details

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 in-person lifestyle program.

Conditions

Behavior, Adolescent

Childhood Obesity

Diabetes Mellitus, Type 2

Pediatric Obesity

Glucose Metabolism Disorders

Study ID

NCT06557317

Start date

Aug, 2024

Status verified date

Aug, 2024

Completion date

Dec 31, 2024

Anticipated

Primary completion date

Dec 31, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 12 - 18

Healthy Volunteers: Not accepted

Inclusion Criteria for adolescent participants:

  • 12-18 years of age
  • self-identify as Black or African American
  • have obesity (>=95th percentile BMI)

Exclusion Criteria for 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 for 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 for caregiver participants:

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

Study Design

Enrollment

60 participants

Anticipated

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Intervention Adolescent/Caregiver Dyads

Adolescent/Caregiver dyads receive 12-week in-person lifestyle program consisting of a Wellness session, Dance Classes, and an at-home Cooking Experience.

Interventions

Black Girls for Wellness In-Person

Weekly for 12 weeks, adolescent/caregiver dyads will attend 1) an in-person Wellness Session (mindfulness, nutrition lesson, dance class, program reflection) (90 min/wk) and 2) a home cooking experience using ingredients provided at the Wellness Session (60 min/wk).

Primary outcome measure

  • Change in diet quality of adolescent participants, as measured by the Healthy Eating Index Scores [ Time Frame: Baseline, 12 weeks [end of study] ]

Central Contacts and Locations

Central contacts

Tashara M Leak, PhD, RD

607-255-7664tml226@cornell.edu

Locations

Brownsville Neighborhood Health Action Center

Recruiting

Brooklyn, New York, United States, 11212

Contacts

Elana Martins

718-312-6135emartin8@health.nyc.gov

More Information

Sponsor

Cornell University

Last update posted

Aug 16, 2024

Last verified

Aug, 2024

Keywords

  • Adolescents
  • In-Person Lifestyle Program
  • Diabetes prevention
  • Black girls
  • Obesity

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Cornell University on 2024-08-16.