Clinical trial NCT06557317: In-Person Lifestyle Program for Black Adolescent Girls at Risk for Type 2 Diabetes
Official title: Examining the Preliminary Efficacy of an In-Person Lifestyle Intervention for Black Female Adolescent/Caregiver Dyads at Risk for Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: 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
Keywords: Adolescents
In-Person Lifestyle Program
Diabetes prevention
Black girls
Obesity
Lead sponsor: Cornell University
Sponsor class: OTHER
First posted: 2024-08-16
Enrollment: 60
Sex: FEMALE
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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 in-person lifestyle program.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in diet quality of adolescent participants, as measured by the Healthy Eating Index Scores
timeFrame: Baseline, 12 weeks [end of study]
Secondary outcomes:
measure: Change in dermal carotenoids level
timeFrame: Baseline, 12 weeks [end of study]
measure: Change in percent time sedentary
timeFrame: Baseline, 12 weeks [end of study]
measure: Change in percent time spent in light activity
timeFrame: Baseline, 12 weeks [end of study]
measure: Change in percent time spent in moderate to vigorous activity
timeFrame: Baseline, 12 weeks [end of study]
measure: Change in HbA1c
timeFrame: Baseline, 12 weeks [end of study]
measure: Change in lipid profile
timeFrame: Baseline, 12 weeks [end of study]
measure: Change in body mass index
timeFrame: Baseline, 12 weeks [end of study]
measure: Change in body fat percentage
timeFrame: Baseline, 12 weeks [end of study]
measure: Change in waist circumference
timeFrame: Baseline, 12 weeks [end of study]
measure: Change in high blood pressure status
timeFrame: Baseline, 12 weeks [end of study]
Other outcomes:
Locations:
city: Brooklyn
country: United States
facility: Brownsville Neighborhood Health Action Center
state: New York
Study officials:
affiliation: Cornell University
name: Tashara M Leak, PhD, RD
role: PRINCIPAL_INVESTIGATOR
References: