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

Sponsor

Weill Medical College of Cornell University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05396443

Collaborator

Cornell University (Other), National Institute on Minority Health and Health Disparities (NIMHD) (NIH)

120

Enrollment

Location

Arms

11.5

Anticipated Duration (Months)

10.4

Patients Per Site Per Month

Study Details

Study Description

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 after participating in a 12-wk telehealth lifestyle program.

Condition or Disease	Intervention/Treatment	Phase
Obesity, Childhood Type2Diabetes	Behavioral: Black Girls for Wellness Behavioral: Control Behavioral: Black Girls for Wellness Caregivers Behavioral: Control Caregivers	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Aug 15, 2022

Anticipated Primary Completion Date :

Aug 1, 2023

Anticipated Study Completion Date :

Aug 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention Adolescent participants receive 12 week telehealth lifestyle program consisting of a Wellness session, Cooking Experience, and Dance Classes. Caregiver participants are encouraged to participate in the program.	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.
Placebo Comparator: Control Adolescent participants receive weekly newsletter to attend public events. The control group will receive a simplified version of the intervention post endpoint data collection. Caregiver participants are encouraged to attend events with the adolescent.	Behavioral: Control Weekly newsletter for adolescent and caregiver participants to attend public events in New York City for 12 weeks. After post endpoint data collection: recording of Black Girls for Wellness lessons, weekly groceries sent to home to create program's recipes, access to dance classes for 12 weeks.
Experimental: Intervention-Caregiver Caregiver of adolescents randomized to the Intervention group are encouraged to participate in the program.	Behavioral: 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.
Placebo Comparator: Control caregiver Caregivers of adolescents in the control group receive weekly newsletter to attend public events. Caregiver participants are encouraged to attend events with the adolescent.	Behavioral: Control Caregivers Weekly newsletter for adolescent and caregiver participants to attend public events in New York City for 12 weeks. Caregivers of adolescents in control group are encouraged to take their children to said events.

Outcome Measures

Primary Outcome Measures

Change in diet quality of adolescent participants, as measured by the Healthy Eating Index Scores [Baseline, 12 weeks [end of study]]
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.

Secondary Outcome Measures

Change in dermal carotenoids level [Baseline, 12 weeks [end of study]]
Scores are measured using the Veggie Meter device, range from 0-800. Higher score acts as proxy for fruits and vegetables consumption.
Change in percent time sedentary [Baseline, 12 weeks [end of study]]
Accelerometry data will be collected from wrist accelerometers worn by participants for 7 days. Percent time spent on sedentary will be calculated.
Change in percent time spent in light activity [Baseline, 12 weeks [end of study]]
Accelerometry data will be collected from wrist accelerometers worn by participants for 7 days. Percent time spent in light activity will be calculated.
Change in percent time spent in moderate to vigorous activity [Baseline, 12 weeks [end of study]]
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.
Change in glucose levels [Baseline, 12 weeks [end of study]]
Fasting glucose and 2 hour glucose levels will be collected through an oral glucose tolerance test.
Change in fasting insulin levels [Baseline, 12 weeks [end of study]]
Insulin level will be assessed through blood draws on fasting participants.
Change in HbA1c [Baseline, 12 weeks [end of study]]
HbA1c will be assessed through blood draws on fasting participants.
Change in lipid profile [Baseline, 12 weeks [end of study]]
Total, high-density, low-density cholesterol, and triglycerides will be assessed through blood draws on fasting participants.
Change in body mass index [Baseline, 12 weeks [end of study]]
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.
Change in body fat percentage [Baseline, 12 weeks [end of study]]
Body fat percentage will be measured using a scale to the nearest decimal.
Change in waist circumference [Baseline, 12 weeks [end of study]]
Waist circumference will be measured using a waist circumference tape to the nearest decimal in cm.
Change in high blood pressure status [Baseline, 12 weeks [end of study]]
Blood pressure will be measured using blood pressure monitors. High blood pressure is considered as reading of >=120/80.

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years to 18 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria for adolescent participants:

12-18 years of age
self-identify as Black or African American
have obesity
have at least one of the following: A) mother has history of diabetes B) first or second degree relatives has history of diabetes (other than mother) C) have signs of insulin resistance, e.g., diagnosis of insulin resistance, metabolic resistance, hyperinsulinemia, or high values fasting insulin levels D) prediabetes diagnosis E) insulin-related conditions e.g., diagnosis of hypertension, dyslipidemia, polycystic ovary syndrome, small or gestational age birth weight, or acanthosis nigricans.

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.