Back to resultsTelehealth Lifestyle Program for Black Adolescent Girls at Risk for Type 2 Diabetes
Primary Purpose
Obesity, Childhood, Type2Diabetes
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Black Girls for Wellness
Black Girls for Wellness Caregivers
Sponsored by
About this trial
This is an interventional prevention trial for Obesity, Childhood focused on measuring Adolescents, Telehealth Lifestyle Program, Diabetes prevention, Black girls, Obesity
Eligibility Criteria
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.
Inclusion criteria of caregiver participants:
- 18 years or older.
- proficiency in speaking English
Sites / Locations
- Weill Cornell MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Intervention
Intervention-Caregiver
Arm Description
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.
Caregiver of adolescents randomized to the Intervention group are encouraged to participate in the program.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
Change in glucose levels
Fasting glucose and 2 hour glucose levels will be collected through an oral glucose tolerance test.
Change in fasting insulin levels
Insulin level will be assessed through blood draws on fasting participants.
Change in HbA1c
HbA1c will be assessed through blood draws on fasting participants.
Change in lipid profile
Total, high-density, low-density cholesterol, and triglycerides will be assessed through blood draws on fasting participants.
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.
Change in body fat percentage
Body fat percentage will be measured using a scale to the nearest decimal.
Change in waist circumference
Waist circumference will be measured using a waist circumference tape to the nearest decimal in cm.
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.
Full Information
NCT ID
NCT05396443
First Posted
May 25, 2022
Last Updated
August 24, 2023
Sponsor
Weill Medical College of Cornell University
Collaborators
Cornell University, National Institute on Minority Health and Health Disparities (NIMHD)
1. Study Identification
Unique Protocol Identification Number
NCT05396443
Brief Title
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
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 15, 2022 (Actual)
Primary Completion Date
January 2025 (Anticipated)
Study Completion Date
January 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Weill Medical College of Cornell University
Collaborators
Cornell University, National Institute on Minority Health and Health Disparities (NIMHD)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Childhood, Type2Diabetes
Keywords
Adolescents, Telehealth Lifestyle Program, Diabetes prevention, Black girls, Obesity
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Intervention-Caregiver
Arm Type
Experimental
Arm Description
Caregiver of adolescents randomized to the Intervention group are encouraged to participate in the program.
Intervention Type
Behavioral
Intervention Name(s)
Black Girls for Wellness
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Black Girls for Wellness Caregivers
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in diet quality of adolescent participants, as measured by the Healthy Eating Index Scores
Description
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.
Time Frame
Baseline, 12 weeks [end of study]
Secondary Outcome Measure Information:
Title
Change in dermal carotenoids level
Description
Scores are measured using the Veggie Meter device, range from 0-800. Higher score acts as proxy for fruits and vegetables consumption.
Time Frame
Baseline, 12 weeks [end of study]
Title
Change in percent time sedentary
Description
Accelerometry data will be collected from wrist accelerometers worn by participants for 7 days. Percent time spent on sedentary will be calculated.
Time Frame
Baseline, 12 weeks [end of study]
Title
Change in percent time spent in light activity
Description
Accelerometry data will be collected from wrist accelerometers worn by participants for 7 days. Percent time spent in light activity will be calculated.
Time Frame
Baseline, 12 weeks [end of study]
Title
Change in percent time spent in moderate to vigorous activity
Description
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.
Time Frame
Baseline, 12 weeks [end of study]
Title
Change in glucose levels
Description
Fasting glucose and 2 hour glucose levels will be collected through an oral glucose tolerance test.
Time Frame
Baseline, 12 weeks [end of study]
Title
Change in fasting insulin levels
Description
Insulin level will be assessed through blood draws on fasting participants.
Time Frame
Baseline, 12 weeks [end of study]
Title
Change in HbA1c
Description
HbA1c will be assessed through blood draws on fasting participants.
Time Frame
Baseline, 12 weeks [end of study]
Title
Change in lipid profile
Description
Total, high-density, low-density cholesterol, and triglycerides will be assessed through blood draws on fasting participants.
Time Frame
Baseline, 12 weeks [end of study]
Title
Change in body mass index
Description
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.
Time Frame
Baseline, 12 weeks [end of study]
Title
Change in body fat percentage
Description
Body fat percentage will be measured using a scale to the nearest decimal.
Time Frame
Baseline, 12 weeks [end of study]
Title
Change in waist circumference
Description
Waist circumference will be measured using a waist circumference tape to the nearest decimal in cm.
Time Frame
Baseline, 12 weeks [end of study]
Title
Change in high blood pressure status
Description
Blood pressure will be measured using blood pressure monitors. High blood pressure is considered as reading of >=120/80.
Time Frame
Baseline, 12 weeks [end of study]
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tashara M Leak, PhD, RD
Phone
646-962-5941
Email
tml226@cornell.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tashara M Leak, PhD, RD
Organizational Affiliation
Weill Medical College of Cornell University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Weill Cornell Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tashara M Leak, PhD, RD
Phone
646-962-5941
Email
tml226@cornell.edu
First Name & Middle Initial & Last Name & Degree
Tashara M Leak, PhD, RD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Telehealth Lifestyle Program for Black Adolescent Girls at Risk for Type 2 Diabetes
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