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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Obesity, Childhood, Type2Diabetes

Intervention / Treatment
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* Behavioral: Black Girls for Wellness
* Behavioral: Black Girls for Wellness Caregivers


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>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<br>* 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.<br>|
| Experimental: Intervention-Caregiver<br>Caregiver of adolescents randomized to the Intervention group are encouraged to participate in the program. | Behavioral: Black Girls for Wellness Caregivers<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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] | 
| 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] | 
| 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] | 
| 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] | 
| 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] | 
| Change in fasting insulin levels | Insulin level will be assessed through blood draws on fasting participants. | Baseline, 12 weeks [end of study] | 
| Change in HbA1c | HbA1c will be assessed through blood draws on fasting participants. | Baseline, 12 weeks [end of study] | 
| 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] | 
| 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] | 
| Change in body fat percentage | Body fat percentage will be measured using a scale to the nearest decimal. | Baseline, 12 weeks [end of study] | 
| 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] | 
| 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] | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adolescents, Telehealth Lifestyle Program, Diabetes prevention, Black girls, Obesity