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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age12-18
SponsorCornell University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

12-18 years of age

self-identify as Black or African American

have obesity (>=95th percentile BMI)

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • 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).

Treatment groups

60 Participants
are divided into 1 treatment group
Group A: Intervention Adolescent/Caregiver DyadsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline, 12 weeks [end of study]

Secondary outcomes

1

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.

Time frame
Baseline, 12 weeks [end of study]
2

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.

Time frame
Baseline, 12 weeks [end of study]
3

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.

Time frame
Baseline, 12 weeks [end of study]
4

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.

Time frame
Baseline, 12 weeks [end of study]

Other outcomes

Sponsors and contacts

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