In-Person Lifestyle Program for Black Adolescent Girls at Risk for Type 2 Diabetes
NCT Number: NCT06557317
Acronym: BGW In-Person
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
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
Interventions: BEHAVIORAL: Black Girls for Wellness In-Person
Sponsor: Cornell University
Sex: FEMALE
Age: CHILD, ADULT
Enrollment: 60
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-08
Completion Date: 2024-12-31
Locations: Brownsville Neighborhood Health Action Center, Brooklyn, New York, 11212, United States

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.

Primary Outcome Measures: 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: 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 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]|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]