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Fitness Support Group Program for Obesity (CBS002 Trial)

N/A
Recruiting
Led By Christine Burt Solorzano, MD
Research Sponsored by University of Virginia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Female
Ages 10-18 yr
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 3 months, 6 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a program to get girls to exercise more and enjoy it more. They will do this by measuring how much they enjoy it before and after the program, as well as how it affects their risk for diseases.

Who is the study for?
This trial is for girls aged 10-18 with conditions like obesity, insulin resistance, PCOS, premature adrenarche, or type 2 diabetes. They should be participating in the Go Girls! program but not be pregnant.
What is being tested?
The study tests if the Go Girls! Fitness Support Group at Kluge Children's Rehabilitation Center helps improve enjoyment of physical activity and impacts health markers like body weight and bloodwork over a six-month period.
What are the potential side effects?
Since this intervention involves exercise and peer support without medical or pharmaceutical treatments, side effects are minimal but may include typical exercise-related discomforts such as muscle soreness.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am female.
Select...
I am between 10 and 18 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 3 months, 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 3 months, 6 months 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 mean score for the PACES scale after 6-months of intervention
Secondary study objectives
Change in amounts of average daily moderate-vigorous exercise
Change in amounts of average daily vigorous exercise
Change in mean score for the PACES scale after 3-months of intervention
+2 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: Go Girls! Fitness Support GroupExperimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
2,055 Previous Clinical Trials
2,731,859 Total Patients Enrolled
35 Trials studying Polycystic Ovary Syndrome
5,812 Patients Enrolled for Polycystic Ovary Syndrome
University of VirginiaLead Sponsor
782 Previous Clinical Trials
1,315,667 Total Patients Enrolled
27 Trials studying Polycystic Ovary Syndrome
1,256 Patients Enrolled for Polycystic Ovary Syndrome
Christine Burt Solorzano, MDPrincipal Investigator - University of Virginia
UVA Child Development & Rehabilitation Center, University of Virginia Medical Center
University Of Virginia School Of Medicine (Medical School)
Children'S Hosp Of L A (Residency)
7 Previous Clinical Trials
260 Total Patients Enrolled
7 Trials studying Polycystic Ovary Syndrome
260 Patients Enrolled for Polycystic Ovary Syndrome
~0 spots leftby Dec 2024
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