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

Obesity, Childhood Clinical Trial

Official title:

A Telehealth Lifestyle Intervention for Black Adolescent Girls at Risk for Type 2 Diabetes: A Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05396443
• Other study ID #: 21-04023546
• Secondary ID: 1R21MD016986-01
• Status: Recruiting
• Phase: N/A
• Start date: August 15, 2022
• Est. completion date: January 2025

Study information

• Verified date: August 2023
• Source: Weill Medical College of Cornell University
• Contact: Tashara M Leak, PhD, RD
• Phone: 646-962-5941
• Email: tml226[@]cornell.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 after participating in a 12-wk telehealth lifestyle program.

Description:

Participants will be divided into 2 groups; the first group will take part in the program, the second group will not. Adolescents' caregivers will also be invited to participate in the program (e.g., attend lessons). The investigators hypothesize that after the program, adolescents' diet will be higher in quality than before, and higher than adolescents who did not receive the program.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: January 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 12 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Obesity, Childhood
• Pediatric Obesity

Intervention

Behavioral:
• Black Girls for Wellness
Weekly for 12 weeks, adolescent participants will attend 1) a live stream group Wellness session (90 min/wk), 2) a home cooking experience using ingredients sent to participants' home (60 min/wk), and 3) one live stream group dance classes via Zoom (60 min/wk); participants will also be encouraged to attend 2 other dance classes during the week at their own convenience. Enrolled caregivers and others in the home (e.g., siblings) will be encouraged to participate in activities.
• Black Girls for Wellness Caregivers
Caregivers of adolescents participating in Black Girls for Wellness will be encouraged to participate in the program's activities with their child. For example, they may help adolescent cook, or participate in the dance classes along with their child.

Locations

Country	Name	City	State
United States	Weill Cornell Medicine	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University	Cornell University, National Institute on Minority Health and Health Disparities (NIMHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in diet quality of adolescent participants, as measured by the Healthy Eating Index Scores	Scores are calculated from three 24-hour diet records, range from 0-100. Higher score reflects that higher alignment between one's diet and dietary recommendations from the Dietary Guidelines for Americans.	Baseline, 12 weeks [end of study]
Secondary	Change in dermal carotenoids level	Scores are measured using the Veggie Meter device, range from 0-800. Higher score acts as proxy for fruits and vegetables consumption.	Baseline, 12 weeks [end of study]
Secondary	Change in percent time sedentary	Accelerometry data will be collected from wrist accelerometers worn by participants for 7 days. Percent time spent on sedentary will be calculated.	Baseline, 12 weeks [end of study]
Secondary	Change in percent time spent in light activity	Accelerometry data will be collected from wrist accelerometers worn by participants for 7 days. Percent time spent in light activity will be calculated.	Baseline, 12 weeks [end of study]
Secondary	Change in percent time spent in moderate to vigorous activity	Accelerometry data will be collected from wrist accelerometers worn by participants for 7 days. Percent time spent in moderate and vigorous activity will be calculated.	Baseline, 12 weeks [end of study]
Secondary	Change in glucose levels	Fasting glucose and 2 hour glucose levels will be collected through an oral glucose tolerance test.	Baseline, 12 weeks [end of study]
Secondary	Change in fasting insulin levels	Insulin level will be assessed through blood draws on fasting participants.	Baseline, 12 weeks [end of study]
Secondary	Change in HbA1c	HbA1c will be assessed through blood draws on fasting participants.	Baseline, 12 weeks [end of study]
Secondary	Change in lipid profile	Total, high-density, low-density cholesterol, and triglycerides will be assessed through blood draws on fasting participants.	Baseline, 12 weeks [end of study]
Secondary	Change in body mass index	Height will be measured using a stadiometer to the nearest decimal point in cm. Weight will be measured using a scale to the nearest decimal in kg. Body mass index will be calculated using kg/m^2.	Baseline, 12 weeks [end of study]
Secondary	Change in body fat percentage	Body fat percentage will be measured using a scale to the nearest decimal.	Baseline, 12 weeks [end of study]
Secondary	Change in waist circumference	Waist circumference will be measured using a waist circumference tape to the nearest decimal in cm.	Baseline, 12 weeks [end of study]
Secondary	Change in high blood pressure status	Blood pressure will be measured using blood pressure monitors. High blood pressure is considered as reading of >=120/80.	Baseline, 12 weeks [end of study]