Clinical trial NCT05396443: Telehealth Lifestyle Program for Black Adolescent Girls at Risk for Type 2 Diabetes
Official title: A Telehealth Lifestyle Intervention for Black Adolescent Girls at Risk for Type 2 Diabetes: A Pilot Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Obesity, Childhood
Type2Diabetes
Keywords: Adolescents
Telehealth Lifestyle Program
Diabetes prevention
Black girls
Obesity
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: Cornell University
name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2022-05-31
Enrollment: 19
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 telehealth lifestyle program.

Detailed 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.

Eligibility 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.

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 glucose levels
timeFrame: Baseline, 12 weeks [end of study]
measure: Change in fasting insulin levels
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: Brooklyn Methodist Hospital
state: New York
city: New York
country: United States
facility: Weill Cornell Medicine
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Tashara M Leak, PhD, RD
role: PRINCIPAL_INVESTIGATOR
References: