In-Person Lifestyle Program for Black Adolescent Girls at Risk for Type 2 Diabetes

NCT06557317 | Recruiting

• 1 other identifier: 0148278
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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; Metabolic Disease; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Diabetes Mellitus

Keywords

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

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 (10)

• 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 HbA1c

  Baseline, 12 weeks [end of study]

Study Arms (1)

Intervention Adolescent/Caregiver Dyads

EXPERIMENTAL

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

Behavioral: Black Girls for Wellness In-Person

Interventions

Black Girls for Wellness In-Person BEHAVIORAL

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).

Intervention Adolescent/Caregiver Dyads

Eligibility Criteria

• Age: 12 Years - 18 Years
• Gender Eligibility Details: Inclusion Criteria for all participants includes biological sex female.
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

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.

Sponsors & Collaborators

• Cornell University: lead

Study Sites (1)

Brownsville Neighborhood Health Action Center

Brooklyn, New York, 11212, United States

RECRUITING

MeSH Terms

Conditions

Adolescent Behavior; Pediatric Obesity; Diabetes Mellitus, Type 2; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Diabetes Mellitus; Obesity

Condition Hierarchy (Ancestors)

Behavior; Nutritional and Metabolic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Tashara M Leak, PhD, RD

  Cornell University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tashara M Leak, PhD, RD

CONTACT

607-255-7664; tml226@cornell.edu

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: August 14, 2024
• First Posted: August 16, 2024
• Study Start: August 1, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: August 16, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)