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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 12 weeks [end of study]
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in diet quality of adolescent participants, as measured by the Healthy Eating Index Scores
Secondary outcome measures
Change in HbA1c
Change in body fat percentage
Change in body mass index
+9 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Intervention-CaregiverExperimental Treatment1 Intervention
Caregiver of adolescents randomized to the Intervention group are encouraged to participate in the program.
Group II: InterventionExperimental Treatment1 Intervention
Adolescent participants receive 12 week telehealth lifestyle program consisting of a Wellness session, Cooking Experience, and Dance Classes. Caregiver participants are encouraged to participate in the program.

Find a Location

Who is running the clinical trial?

National Institute on Minority Health and Health Disparities (NIMHD)NIH
380 Previous Clinical Trials
1,215,534 Total Patients Enrolled
Weill Medical College of Cornell UniversityLead Sponsor
1,054 Previous Clinical Trials
1,316,408 Total Patients Enrolled
Cornell UniversityOTHER
166 Previous Clinical Trials
14,089,740 Total Patients Enrolled

Media Library

Black Girls for Wellness Clinical Trial Eligibility Overview. Trial Name: NCT05396443 — N/A
Childhood Obesity Research Study Groups: Intervention, Intervention-Caregiver
Childhood Obesity 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still availabilities for prospective participants in this clinical experiment?

"Current information on clinicaltrials.gov shows this research is actively enlisting participants, with the initial post being made on August 15th 2022 and the most recent update from 8/22/2022."

Answered by AI

What is the highest capacity of participants in this clinical trial?

"Affirmative, the clinicaltrial.gov webpage conveys that this trial is actively enrolling participants. This study was initially launched on August 15th 2022 and its parameters were most recently adjusted on August 22nd of the same year. Presently it requires 120 patients to be recruited at a single location."

Answered by AI

Who meets the eligibility requirements for participation in this research?

"This clinical study is welcoming 120 participants with type 2 diabetes mellitus between the ages of 12 and 18."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Telehealth Lifestyle Program for Black Adolescent Girls at Risk for Type 2 Diabetes
2022. "Telehealth Lifestyle Program for Black Adolescent Girls at Risk for Type 2 Diabetes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05396443.
~34 spots leftby Jan 2025
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