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Telehealth Lifestyle Program for Type 2 Diabetes Risk in Adolescents

N/A
Recruiting
Led By Tashara M Leak, PhD, RD
Research Sponsored by Weill Medical College of Cornell University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adolescent participants must have obesity
Caregiver participants must be 18 years or older
Must not have
Adolescent participants must not be currently taking medications or diagnosed with a condition known to influence metabolism, physical activity ability, or cognitive function
Adolescent participants must not have previously undergone bariatric surgery
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 12 weeks [end of study]
Awards & highlights
No Placebo-Only Group

Summary

This trial looks at how a 12-week lifestyle program affects diabetes-related risk factors in black adolescent girls who are at risk for type 2 diabetes.

Who is the study for?
This trial is for Black adolescent girls aged 12-18 with obesity, at risk for type 2 diabetes, and their caregivers. Girls must not be on metabolism-affecting meds or have conditions impacting metabolism or cognitive function. They also shouldn't be pregnant/postpartum recently, in a weight program recently, have communication issues due to developmental conditions, have type 2 diabetes already, or had bariatric surgery.
What is being tested?
The study tests a telehealth lifestyle program tailored for Black adolescent girls at risk of developing type 2 diabetes. It involves the participants and their caregivers over a period of 12 weeks to observe changes in diabetes-related risk factors.
What are the potential side effects?
Since this is a lifestyle intervention rather than medication-based treatment, typical drug side effects are not expected. However, participants may experience stress or discomfort from new diet/exercise routines.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a teenager and I am obese.
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I am a caregiver and I am 18 years old or older.
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I am between 12 and 18 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not on medication or diagnosed with a condition that affects my metabolism, physical activity, or thinking.
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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 pregnant or within 3 months after giving birth.

Timeline

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
+9 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 Adolescents-Caregiver DyadsExperimental Treatment1 Intervention
Adolescent-caregiver dyads receive 12 week telehealth lifestyle program consisting of a Wellness session, Cooking Experience, and Dance Classes.

Find a Location

Who is running the clinical trial?

National Institute on Minority Health and Health Disparities (NIMHD)NIH
434 Previous Clinical Trials
1,378,713 Total Patients Enrolled
16 Trials studying Diabetes
15,963 Patients Enrolled for Diabetes
Weill Medical College of Cornell UniversityLead Sponsor
1,088 Previous Clinical Trials
1,154,877 Total Patients Enrolled
5 Trials studying Diabetes
36,398 Patients Enrolled for Diabetes
Cornell UniversityOTHER
171 Previous Clinical Trials
14,088,662 Total Patients Enrolled
1 Trials studying Diabetes
167 Patients Enrolled for Diabetes

Media Library

Black Girls for Wellness Clinical Trial Eligibility Overview. Trial Name: NCT05396443 — N/A
Diabetes Research Study Groups: Intervention Adolescents-Caregiver Dyads
Diabetes Clinical Trial 2023: Black Girls for Wellness Highlights & Side Effects. Trial Name: NCT05396443 — N/A
Black Girls for Wellness 2023 Treatment Timeline for Medical Study. Trial Name: NCT05396443 — N/A
~4 spots leftby Jan 2025
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