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

Examining the Preliminary Efficacy of an In-Person Lifestyle Intervention for Black Female Adolescent/Caregiver Dyads at Risk for Type 2 Diabetes Mellitus

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.

Study Overview

• Status: Recruiting
• Conditions: Glucose Metabolism Disorders; Diabetes Mellitus, Type 2; Diabetes Mellitus; Endocrine System Diseases; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Pediatric Obesity; Childhood Obesity; Metabolic Disease; Behavior, Adolescent
• Intervention / Treatment: Behavioral: Black Girls for Wellness In-Person

Detailed Description

Enrolled adolescent/caregiver dyads will participate in the 12-week program. Each week, participants will engage in 2 activities: an in-person Wellness Session and an at-home cooking experience using ingredients provided at the Wellness Session.

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tashara M Leak, PhD, RD; Phone Number: 607-255-7664; Email: tml226@cornell.edu

Study Locations

• United States
  • New York
    • Brooklyn, New York, United States, 11212
      • Recruiting
      • Brownsville Neighborhood Health Action Center
      • Contact: Elana Martins; Phone Number: 718-312-6135; Email: emartin8@health.nyc.gov

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Behavioral: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in dermal carotenoids level	Scores are measured using the Veggie Meter device, range from 0-800. Higher score acts as proxy for fruits and vegetables consumption.	Baseline, 12 weeks [end of study]
Change in percent time sedentary	Accelerometry data will be collected from wrist accelerometers worn by participants for 7 days. Percent time spent on sedentary will be calculated.	Baseline, 12 weeks [end of study]
Change in percent time spent in light activity	Accelerometry data will be collected from wrist accelerometers worn by participants for 7 days. Percent time spent in light activity will be calculated.	Baseline, 12 weeks [end of study]
Change in percent time spent in moderate to vigorous activity	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.	Baseline, 12 weeks [end of study]
Change in body mass index	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.	Baseline, 12 weeks [end of study]
Change in body fat percentage	Body fat percentage will be measured using a scale to the nearest decimal.	Baseline, 12 weeks [end of study]
Change in waist circumference	Waist circumference will be measured using a waist circumference tape to the nearest decimal in cm.	Baseline, 12 weeks [end of study]
Change in high blood pressure status	Blood pressure will be measured using blood pressure monitors. High blood pressure is considered as reading of >=120/80.	Baseline, 12 weeks [end of study]
Change in HbA1c	HbA1c will be assessed through a blood draw.	Baseline, 12 weeks [end of study]
Change in lipid profile	Total, high-density, low-density cholesterol, and triglycerides will be assessed through a blood draws.	Baseline, 12 weeks [end of study]

Collaborators and Investigators

• Sponsor: Cornell University
• Investigators: Principal Investigator: Tashara M Leak, PhD, RD, Cornell University

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2024
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: August 14, 2024
• First Submitted That Met QC Criteria: August 14, 2024
• First Posted (Actual): August 16, 2024

Study Record Updates

• Last Update Posted (Actual): August 16, 2024
• Last Update Submitted That Met QC Criteria: August 14, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Adolescents; Obesity; Diabetes prevention; Black girls; In-Person Lifestyle Program
• Additional Relevant MeSH Terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Obesity; Pediatric Obesity; Overweight; Body Weight; Nutrition Disorders; Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Overnutrition
• Other Study ID Numbers: 0148278

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No