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Behavioral Intervention

Lifestyle Program for Type 2 Diabetes Risk in Black Adolescent Girls (BGW In-Person Trial)

N/A

Recruiting

Led By Tashara M Leak, PhD, RD

Research Sponsored by Cornell University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adolescent participants must be 12-18 years of age

Caregiver participants must prepare the majority (>50%) of meals in the household

Must not have

Adolescent participants must not have previously undergone bariatric surgery

Adolescent participants must not have type 2 diabetes

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 12 weeks [end of study]

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to see how a 12-week lifestyle program affects diabetes-related risk factors in Black adolescent girls at risk for type 2 diabetes and their female caregivers.

Who is the study for?

This trial is for Black adolescent girls at risk for type 2 diabetes and their primary female caregivers. Participants will engage in a 12-week in-person lifestyle program designed to address diabetes-related risk factors.

What is being tested?

The study tests the effectiveness of the 'Black Girls for Wellness In-Person' program on reducing diabetes-related risk factors among participants through lifestyle changes over a period of 12 weeks.

What are the potential side effects?

Since this is a lifestyle intervention program, there are no direct medical side effects like those from medication. However, participants may experience fatigue or muscle soreness from increased physical activity.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 12 and 18 years old.

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I prepare most of the meals at home.

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My BMI is in the 95th percentile or higher, indicating obesity.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am a teenager and have not had weight loss surgery.

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I am a teenager and I do not have type 2 diabetes.

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I am not on medication nor have conditions affecting my metabolism, physical, or mental abilities.

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I am not pregnant or within 3 months after giving birth.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 12 weeks [end of study]

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 12 weeks [end of study]

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 12 weeks [end of study] for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

Change in HbA1c

Change in body fat percentage

Change in body mass index

+7 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Intervention Adolescent/Caregiver DyadsExperimental Treatment1 Intervention

Adolescent/Caregiver dyads receive 12-week in-person lifestyle program consisting of a Wellness session, Dance Classes, and an at-home Cooking Experience.

0 / 7Eligibility criteria met