In-Person Lifestyle Program for Black Adolescent Girls at Risk for Type 2 Diabetes (BGW In-Person)

Cornell University

Status: Enrolling

Conditions: Nutrition Disorders; Diabetes Mellitus; Body Weight; Pediatric Obesity; Diabetes Mellitus, Type 2; Endocrine System Diseases; Overweight; Glucose Metabolism Disorders; Childhood Obesity; Overnutrition; Metabolic Disease; Behavior, Adolescent

Treatments: Behavioral: Black Girls for Wellness In-Person

Study type: Interventional

Funder types: Other

Identifiers

NCT06557317

0148278

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: Female

Ages: 12 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

Intervention Adolescent/Caregiver Dyads

Experimental group

Description:

Adolescent/Caregiver dyads receive 12-week in-person lifestyle program consisting of a Wellness session, Dance Classes, and an at-home Cooking Experience.

Treatment:

Behavioral: Black Girls for Wellness In-Person