In-Person Lifestyle Program for Black Adolescent Girls at Risk for Type 2 Diabetes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Black Girls for Wellness In-Person.
- Who it may be relevant to
- Registry conditions: Behavior, Adolescent, Childhood Obesity, Diabetes Mellitus, Type 2, Pediatric Obesity. Basic parameters: 12 years — 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Interventions
- 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).
Primary outcome measures
- Change in diet quality of adolescent participants, as measured by the Healthy Eating Index Scores [Time frame: Baseline, 12 weeks [end of study]]
Secondary outcome measures (10)
- Change in dermal carotenoids level [Time frame: Baseline, 12 weeks [end of study]]
- Change in percent time sedentary [Time frame: Baseline, 12 weeks [end of study]]
- Change in percent time spent in light activity [Time frame: Baseline, 12 weeks [end of study]]
- Change in percent time spent in moderate to vigorous activity [Time frame: Baseline, 12 weeks [end of study]]
- Change in HbA1c [Time frame: Baseline, 12 weeks [end of study]]
- Change in lipid profile [Time frame: Baseline, 12 weeks [end of study]]
- Change in body mass index [Time frame: Baseline, 12 weeks [end of study]]
- Change in body fat percentage [Time frame: Baseline, 12 weeks [end of study]]
- Change in waist circumference [Time frame: Baseline, 12 weeks [end of study]]
- Change in high blood pressure status [Time frame: Baseline, 12 weeks [end of study]]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
United States · 1 center
- Brownsville Neighborhood Health Action Center — Brooklyn
Identifiers
NCT: NCT06557317 · 0148278