NCT Number: NCT05396443
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.
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Notify Me12 year–18 year
Female
Interventional
Not applicable
Brooklyn Methodist Hospital, Brooklyn, New York, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
for adolescent participants:
Exclusion criteria
of adolescent participants:
Inclusion criteria
of caregiver participants:
Exclusion criteria
of caregiver participants:
Weekly for 12 weeks, adolescent-caregiver dyads will attend 1) a live stream group Wellness (mindfulness, nutrition lesson, dance class, program reflection) session (90 min/wk) and 2) a home cooking experience using ingredients sent to participants' homes (60 min/wk) with their caregiver. Others in the home (e.g., siblings) will be encouraged to participate in activities as well.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, 12 weeks [end of study]
Body fat percentage will be measured using a scale to the nearest decimal.
Time frame: Baseline, 12 weeks [end of study]
Waist circumference will be measured using a waist circumference tape to the nearest decimal in cm.
Time frame: 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.
Cornell University
Other
A Telehealth Lifestyle Intervention for Black Adolescent Girls at Risk for Type 2 Diabetes: A Pilot Study
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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