An interventional study of Black Girls for Wellness In-Person in Behavior, Adolescent, Childhood Obesity and Diabetes Mellitus, Type 2, sponsored by Cornell University. Recruiting at 1 site in United States. Open to female participants aged 12 Years to 18 Years. Per ClinicalTrials.gov, last updated 2024-08-16.
Sponsored by Cornell University · Not applicable, Interventional, and Prevention
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.
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.
305 studies on the registry are indexed under Adolescent Behavior; 47 are open to participants now.
This study's planned enrollment of 60 is below the median of 172 across 256 interventional studies indexed under Adolescent Behavior.
Browse Adolescent Behavior studies →Cornell University is the lead sponsor of 103 studies on the registry; 16 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria for adolescent participants:
Exclusion Criteria for adolescent participants:
Inclusion Criteria for caregiver participants:
Exclusion Criteria for caregiver participants:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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).
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.
Time frame: Baseline, 12 weeks [end of study]
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, 12 weeks [end of study]
Change in HbA1c
HbA1c will be assessed through a blood draw.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, 12 weeks [end of study]
Change in body fat percentage
Body fat percentage will be measured using a scale to the nearest decimal.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, 12 weeks [end of study]
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Aug 2024; primary completion for Dec 2024, 4 months later.
Of 195 non-industry interventional studies with no phase under Adolescent Behavior, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 43. This study's planned 4 months is below that.
Counting every sponsor, half of 198 studies reached it within 20 months; a quarter within 8 and three quarters within 40.
How these figures are worked out, and which studies are left out of them.
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