Telehealth Lifestyle Program for Black Adolescent Girls at Risk for Type 2 Diabetes
- Conditions
- Type2DiabetesObesity, Childhood
- Interventions
- Behavioral: Black Girls for Wellness Telehealth
- Registration Number
- NCT05396443
- Lead Sponsor
- Weill Medical College of Cornell University
- 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.
- Detailed Description
Enrolled adolescent/caregiver dyads will participate in the 12-week program. Each week, participants will engage in 2 activities: a live virtual Wellness Session and an at-home cooking experience using ingredients sent to them via grocery delivery service.
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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 19
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Intervention Adolescents-Caregiver Dyads Black Girls for Wellness Telehealth Adolescent-caregiver dyads receive 12 week telehealth lifestyle program consisting of a Wellness session, Cooking Experience, and Dance Classes.
- Primary Outcome Measures
Name Time Method Change in diet quality of adolescent participants, as measured by the Healthy Eating Index Scores Baseline, 12 weeks [end of study] 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.
- Secondary Outcome Measures
Name Time Method Change in dermal carotenoids level Baseline, 12 weeks [end of study] Scores are measured using the Veggie Meter device, range from 0-800. Higher score acts as proxy for fruits and vegetables consumption.
Change in glucose levels Baseline, 12 weeks [end of study] Fasting glucose and 2 hour glucose levels will be collected through an oral glucose tolerance test.
Subjects enrolled after May 13 2024 will not complete this test to address recruitment barriers (e.g., availability/ time needed for 2 hour test).Change in percent time spent in light activity Baseline, 12 weeks [end of study] Accelerometry data will be collected from wrist accelerometers worn by participants for 7 days. Percent time spent in light activity will be calculated.
Change in HbA1c Baseline, 12 weeks [end of study] HbA1c will be assessed through blood draws on fasting participants.
Subjects enrolled after May 13 2024 will not be required to fast for this test to address recruitment barriers (e.g., availability for morning appointment) and reduce participant burden.Change in high blood pressure status Baseline, 12 weeks [end of study] Blood pressure will be measured using blood pressure monitors. High blood pressure is considered as reading of \>=120/80.
Change in percent time spent in moderate to vigorous activity Baseline, 12 weeks [end of study] 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.
Change in percent time sedentary Baseline, 12 weeks [end of study] Accelerometry data will be collected from wrist accelerometers worn by participants for 7 days. Percent time spent on sedentary will be calculated.
Change in lipid profile Baseline, 12 weeks [end of study] Total, high-density, low-density cholesterol, and triglycerides will be assessed through blood draws on fasting participants.
Subjects enrolled after May 13 2024 will not be required to fast for this test to address recruitment barriers (e.g., availability for morning appointment) and reduce participant burden.Change in waist circumference Baseline, 12 weeks [end of study] Waist circumference will be measured using a waist circumference tape to the nearest decimal in cm.
Change in body fat percentage Baseline, 12 weeks [end of study] Body fat percentage will be measured using a scale to the nearest decimal.
Change in fasting insulin levels Baseline, 12 weeks [end of study] Insulin level will be assessed through blood draws on fasting participants.
Subjects enrolled after May 13 2024 will not be required to fast for this test to address recruitment barriers (e.g., availability for morning appointment) and reduce participant burden.Change in body mass index Baseline, 12 weeks [end of study] 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.
Trial Locations
- Locations (2)
Brooklyn Methodist Hospital
🇺🇸Brooklyn, New York, United States
Weill Cornell Medicine
🇺🇸New York, New York, United States