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NCT Number: NCT06557317

In-Person Lifestyle Program for Black Adolescent Girls at Risk for Type 2 Diabetes

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 in-person lifestyle program.

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Key information

Age range

12 year–18 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Brownsville Neighborhood Health Action Center

Brooklyn, New York, 11212, United States

Location status: Recruiting

Location contact

Elana Martins

CONTACT

[email protected]

718-312-6135

About this study

Enrolled adolescent/caregiver dyads will participate in the 12-week program. Each week, participants will engage in 2 activities: an in-person Wellness Session and an at-home cooking experience using ingredients provided at the Wellness Session.

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

for adolescent participants:

  • 12-18 years of age
  • self-identify as Black or African American
  • have obesity (>=95th percentile BMI)

Exclusion criteria

for 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

for caregiver participants:

  • 18 years or older.
  • proficiency in speaking English.
  • live in the same household as the adolescent who will also be enrolled.
  • prepares the majority (>50%) of meals in the household.

Exclusion criteria

for caregiver participants:

  • pregnant or within 3 months postpartum.
  • unable to speak English or have developmental conditions that interfere with ability to communicate.

Treatment and study plan

Black Girls for Wellness In-Person

Behavioral

Weekly for 12 weeks, adolescent/caregiver dyads will attend 1) an in-person Wellness Session (mindfulness, nutrition lesson, dance class, program reflection) (90 min/wk) and 2) a home cooking experience using ingredients provided at the Wellness Session (60 min/wk).

Primary outcomes

  1. Change in diet quality of adolescent participants, as measured by the Healthy Eating Index Scores

    Time frame: 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 outcomes

  1. Change in dermal carotenoids level

    Time frame: 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.

  2. Change in percent time sedentary

    Time frame: 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.

  3. Change in percent time spent in light activity

    Time frame: 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.

  4. Change in percent time spent in moderate to vigorous activity

    Time frame: 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.

  5. Change in HbA1c

    Time frame: Baseline, 12 weeks [end of study]

    HbA1c will be assessed through a blood draw.

  6. Change in lipid profile

    Time frame: Baseline, 12 weeks [end of study]

    Total, high-density, low-density cholesterol, and triglycerides will be assessed through a blood draws.

  7. Change in body mass index

    Time frame: 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.

  8. Change in body fat percentage

    Time frame: Baseline, 12 weeks [end of study]

    Body fat percentage will be measured using a scale to the nearest decimal.

  9. Change in waist circumference

    Time frame: Baseline, 12 weeks [end of study]

    Waist circumference will be measured using a waist circumference tape to the nearest decimal in cm.

  10. Change in high blood pressure status

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Tashara M Leak, PhD, RD

CONTACT

[email protected]

607-255-7664

Sponsors and collaborators

Lead sponsor

Cornell University

Other

Registry information

Official study title

Examining the Preliminary Efficacy of an In-Person Lifestyle Intervention for Black Female Adolescent/Caregiver Dyads at Risk for Type 2 Diabetes Mellitus

Acronym: BGW In-Person

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Aug 16, 2024
Registry last updated
Aug 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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