Telehealth Lifestyle Program for Black Adolescent Girls at Risk for Type 2 Diabetes

Cornell University

Status: Completed

Conditions: Type2Diabetes; Obesity, Childhood

Treatments: Behavioral: Black Girls for Wellness Telehealth

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05396443

21-04023546

1R21MD016986-01 (U.S. NIH Grant/Contract)

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 telehealth lifestyle program.

Full description

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.

Enrollment: 19 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

Exclusion Criteria of 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 of 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 of 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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19 participants in 1 patient group

Intervention Adolescents-Caregiver Dyads

Experimental group

Description:

Adolescent-caregiver dyads receive 12 week telehealth lifestyle program consisting of a Wellness session, Cooking Experience, and Dance Classes.

Treatment:

Behavioral: Black Girls for Wellness Telehealth