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| ID | Type | Description | Link |
|---|---|---|---|
| 1R21MD016986-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Weill Medical College of Cornell University | OTHER |
| National Institute on Minority Health and Health Disparities (NIMHD) | NIH |
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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 and their primary female caregiver after both participating in a 12-week telehealth lifestyle program.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Adolescents-Caregiver Dyads | Experimental | Adolescent-caregiver dyads receive 12 week telehealth lifestyle program consisting of a Wellness session, Cooking Experience, and Dance Classes. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Black Girls for Wellness Telehealth | Behavioral | Weekly for 12 weeks, adolescent-caregiver dyads will attend 1) a live stream group Wellness (mindfulness, nutrition lesson, dance class, program reflection) session (90 min/wk) and 2) a home cooking experience using ingredients sent to participants' homes (60 min/wk) with their caregiver. Others in the home (e.g., siblings) will be encouraged to participate in activities as well. |
| 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] |
| 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 |
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Inclusion Criteria for adolescent participants:
Exclusion Criteria of adolescent participants:
Inclusion criteria of caregiver participants:
Exclusion Criteria of caregiver participants:
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| Name | Affiliation | Role |
|---|---|---|
| Tashara M Leak, PhD, RD | Weill Medical College of Cornell University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brooklyn Methodist Hospital | Brooklyn | New York | 11215 | United States | ||
| Weill Cornell Medicine |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 30, 2026 | |
| Unrelease | Mar 31, 2026 | |
| Release | Mar 31, 2026 | |
| Reset | Apr 20, 2026 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | May 13, 2024 | Feb 26, 2025 | ICF_000.pdf |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 30, 2026 | Mar 31, 2026 | |||
| Mar 31, 2026 |
| ID | Term |
|---|---|
| D063766 | Pediatric Obesity |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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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. Subjects enrolled after May 13 2024 will not complete this test to address recruitment barriers (e.g., availability/ time needed for 2 hour test). | Baseline, 12 weeks [end of study] |
| Change in fasting insulin levels | Insulin level will be assessed through blood draws on fasting participants. Subjects enrolled after May 13 2024 will not be required to fast for this test to address recruitment barriers (e.g., availability for morning appointment) and reduce participant burden. | Baseline, 12 weeks [end of study] |
| Change in HbA1c | HbA1c will be assessed through blood draws on fasting participants. Subjects enrolled after May 13 2024 will not be required to fast for this test to address recruitment barriers (e.g., availability for morning appointment) and reduce participant burden. | 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. Subjects enrolled after May 13 2024 will not be required to fast for this test to address recruitment barriers (e.g., availability for morning appointment) and reduce participant burden. | 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] |
| New York |
| New York |
| 10021 |
| United States |
| Apr 20, 2026 |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |