Go Girls! Fitness Support Group Intervention Effectiveness Study (CBS002)
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|ClinicalTrials.gov Identifier: NCT02117063|
Recruitment Status : Recruiting
First Posted : April 17, 2014
Last Update Posted : November 19, 2020
|Condition or disease||Intervention/treatment||Phase|
|Polycystic Ovary Syndrome Abnormal Weight Gain Excess Weight Insulin Resistance Premature Adrenarche Type 2 Diabetes Mellitus||Behavioral: Go Girls! Fitness Support Group||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||35 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Go Girls! Fitness Support Group Intervention Effectiveness Study|
|Study Start Date :||April 2012|
|Estimated Primary Completion Date :||December 2022|
|Estimated Study Completion Date :||December 2022|
|Experimental: Go Girls! Fitness Support Group||
Behavioral: Go Girls! Fitness Support Group
Go Girls! is a dance-based patient fitness support group offered by the University of Virginia Pediatric Endocrinology division in conjunction with the Center for Research in Reproduction and the Children's Fitness Clinic at the University of Virginia for girls. The goals of the program are to introduce girls to exercise in a fun, non-threatening environment, meet other girls, enable girls to discover and develop a personal enjoyment of exercise, and enable low-pressure interactions with medical care providers.
- Change in mean score for the PACES scale after 6-months of intervention [ Time Frame: Baseline and 6 months ]Enjoyment of exercise will be assessed by scores on the PACES modified for adolescent girls, which is scored on a scale of 1 to 5.
- Change in mean score for the PACES scale after 3-months of intervention [ Time Frame: Baseline and 3 months ]Enjoyment of exercise will be assessed by scores on the PACES modified for adolescent girls, which is scored on a scale of 1 to 5.
- Change in amounts of average daily moderate-vigorous exercise [ Time Frame: Baseline, 3 months, and 6 months ]Amounts of average daily moderate-vigorous exercise will be assessed by recall of previous week's exercise amounts spent doing moderate-vigorous physical activity.
- Change in amounts of average daily vigorous exercise [ Time Frame: Baseline, 3 months, and 6 months ]Amounts of average daily vigorous exercise will be assessed by recall of previous week's exercise amounts spent doing vigorous physical activity
- Changes in attitudes about exercise [ Time Frame: Baseline, 3 months, 6 months ]Responses will be compiled into descriptive summaries/themes of girls' attitudes before, during, and after the intervention
- Changes in anthropometric and biochemical indices of metabolism and possible PCOS [ Time Frame: Baseline, 3 months, 6 months ]We will be assessing changes in blood pressure, body mass index total and percentile-for-age, waist circumference, serum markers of androgen excess and/or PCOS (free testosterone calculated from total testosterone and sex hormone binding globulin, dehydroepiandrosterone sulfate, and luteinizing hormone: follicle stimulation hormone ratio), serum markers of insulin resistance (insulin, glucose, HbA1c), and lipid abnormalities (HDL, LDL, triglycerides)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02117063
|Contact: Melissa Gilrainemail@example.com|
|Contact: Christine Burt Solorzano, MDfirstname.lastname@example.org|
|United States, Virginia|
|Center for Research in Reproduction, University of Virginia||Recruiting|
|Charlottesville, Virginia, United States, 22908|
|Contact: Melissa Gilrain 434-243-6911 email@example.com|
|Contact: Christine M Burt Solorzano, MD 434-924-9084 firstname.lastname@example.org|
|Principal Investigator: Christine M Burt Solorzano, MD|
|Principal Investigator:||Christine Burt Solorzano, MD||University of Virginia|