Polycystic Ovary SyndromeCBS002NCT02117063
Go Girls! Fitness Support Group Intervention Effectiveness Study
A study testing Go Girls! Fitness Support Group in people with Polycystic Ovary Syndrome and Abnormal Weight Gain, run by University of Virginia at 1 site in United States.
Trial summary
The main purpose of this study is to determine if the Go Girls! program to take place at the Kluge Children's Rehabilitation Center Therapeutic Recreation Gymnasium, intended to introduce girls to a fun, non-threatening environment of exercise with peer support, improves scores on a physical activity enjoyment scale… Read more about this study
- Who is it for?
- Ages 10 to 18 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome, Abnormal Weight Gain, Excess Weight
- What is being tested?
- Go Girls! Fitness Support Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2012to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 18 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Female
- Ages 10-18 yr
- Participating in the Go Girls! program
- With diagnoses of abnormal weight gain, excess weight, insulin resistance, PCOS, premature adrenarche, or type 2 diabetes mellitus
Who cannot join
- Known pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Center for Research in Reproduction, University of Virginia
Charlottesville, Virginia, 22908
Melissa Gilrain, 434-243-6911, pcos@virginia.edu
Christine M Burt Solorzano, MD, 434-924-9084, pcos@virginia.edu
About this study
The main purpose of this study is to determine if the Go Girls! program to take place at the Kluge Children's Rehabilitation Center Therapeutic Recreation Gymnasium, intended to introduce girls to a fun, non-threatening environment of exercise with peer support, improves scores on a physical activity enjoyment scale (PACES). Information regarding enjoyment of physical activity before and after the program will allow objective evaluation of whether the program is achieving its mission. Qualitative responses to the questionnaires will give program leaders a better sense of potential attitudes and barriers to regular exercise for teen girls. These responses will be used to shape activities during this or future programs for teens. Anthropometric (e.g. body weight, blood pressure, waist circumference) and biochemical (bloodwork) data will allow us to determine whether any change in metabolic risk factors can be seen from this 6-month once weekly intervention.
Read the detailed description
Adolescent girls have low participation in physical activity compared to boys at all ages. Interventions to improve physical activity levels in children have shown greatest success when targeted to low-active adolescent girls and employ strategies to enhance adolescents' enjoyment of physical activity. Go Girls! is a new dance-based patient fitness support group being offered via the Pediatric Endocrinology division in conjunction with the Center for Research in Reproduction and the Children's Fitness Clinic for girls at-risk for weight-related medical complications, particularly those with excess weight, polycystic ovary syndrome (PCOS), diabetes mellitus, or insulin resistance. The goals of the program are to introduce girls to exercise in a fun, non-threatening environment, meet other girls with similar health concerns, enable girls to discover and develop a personal enjoyment of exercise, and enable low-pressure interactions with medical care providers. The primary aim of this study is to determine changes in girls' enjoyment of exercise. Our hypothesis is that introducing girls to a fun, non-threatening environment of exercise with peer support will modify scores on a physical activity enjoyment scale. Secondary aims will assess for changes in weekly exercise, attitudes about exercise, and metabolic parameters and evidence for androgen (male hormone) excess (a precursor to PCOS). Subjects will be recruited from girls already participating in the Go Girls! program. Go Girls! is open to girls ages 10-18 yr with diagnoses of abnormal weight gain, excess weight, insulin resistance, PCOS, premature adrenarche, or type 2 diabetes mellitus previously cared for by the Pediatric Endocrinology or Children's Fitness Clinics. Questionnaire, anthropometric, and optional fasting biochemical information will be collected from girls at the beginning (first month), middle (third month), and end of a 6-month exercise/support group intervention. Assessment of the primary aim will be by comparing scores on the validated Physical Activity Enjoyment Scale (PACES) compared before, during and after the intervention. Secondary aims will be assessed via self-reported estimates of weekly exercise, qualitative written assessments of attitudes towards exercise, and changes in biochemical data. Data obtained from the questionnaire will be used to assess the primary aim of this protocol. The biochemical information, obtained via optional blood draws at the beginning, middle, and end of the 6-month exercise/support group intervention will be used to address one of the secondary aims. These blood draws are optional so as not to deter subjects from participating in the main part of the study. Data from the questionnaire and anthropometric measurements will be useful for testing the primary and some of the secondary aims of this study, regardless of whether or not fasting biochemical information is obtained.
- Conditions
- Polycystic Ovary Syndrome, Abnormal Weight Gain, Excess Weight, Insulin Resistance, Premature Adrenarche, Type 2 Diabetes Mellitus
- Being tested
- Go Girls! Fitness Support Group
- Medical subject headings
- Polycystic Ovary Syndrome, Insulin Resistance, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Go Girls! Fitness Support GroupBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Go Girls! Fitness Support Group | Experimental | Not described Receives: Behavioral: Go Girls! Fitness Support Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in mean score for the PACES scale after 6-months of intervention
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.
Measured: Baseline and 6 months
Secondary outcomes (5)
Change in mean score for the PACES scale after 3-months of intervention
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.
Measured: Baseline and 3 months
Change in amounts of average daily moderate-vigorous exercise
Amounts of average daily moderate-vigorous exercise will be assessed by recall of previous week's exercise amounts spent doing moderate-vigorous physical activity.
Measured: Baseline, 3 months, and 6 months
Change in amounts of average daily vigorous exercise
Amounts of average daily vigorous exercise will be assessed by recall of previous week's exercise amounts spent doing vigorous physical activity
Measured: Baseline, 3 months, and 6 months
Changes in attitudes about exercise
Responses will be compiled into descriptive summaries/themes of girls' attitudes before, during, and after the intervention
Measured: Baseline, 3 months, 6 months
Changes in anthropometric and biochemical indices of metabolism and possible PCOS
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)
Measured: Baseline, 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2014 (estimated)
- Study startApr 2012
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Christine Burt Solorzano, University of Virginia
- Investigators
- Christine Burt Solorzano, MD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02117063
- Sponsor's protocol ID
- 16132
- Other IDs
- U54HD028934-18
- Acronym
- CBS002
- Status last verified
- Oct 2023
- First submitted
- 15 Apr 2014
- Last updated
- 27 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Go Girls! Fitness Support Group Intervention Effectiveness Study
- ClinicalTrials.gov ID
- NCT02117063
- Acronym / sponsor ID
- CBS002 / 16132
- Conditions
- Polycystic Ovary Syndrome, Abnormal Weight Gain, Excess Weight, Insulin Resistance, Premature Adrenarche, Type 2 Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Apr 2012
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 17 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main purpose of this study is to determine if the Go Girls! program to take place at the Kluge Children's Rehabilitation Center Therapeutic Recreation Gymnasium, intended to introduce girls to a fun, non-threatening environment of exercise with peer support, improves scores on a physical activity enjoyment scale (PACES). Information regarding enjoyment of physical activity before and after the program will allow objective evaluation of whether the program is achieving its mission. Qualitative responses to the questionnaires will give program leaders a better sense of potential attitudes and barriers to regular exercise for teen girls. These responses will be used to shape activities during this or future programs for teens. Anthropometric (e.g. body weight, blood pressure, waist circumference) and biochemical (bloodwork) data will allow us to determine whether any change in metabolic risk factors can be seen from this 6-month once weekly intervention.
Detailed description
Adolescent girls have low participation in physical activity compared to boys at all ages. Interventions to improve physical activity levels in children have shown greatest success when targeted to low-active adolescent girls and employ strategies to enhance adolescents' enjoyment of physical activity. Go Girls! is a new dance-based patient fitness support group being offered via the Pediatric Endocrinology division in conjunction with the Center for Research in Reproduction and the Children's Fitness Clinic for girls at-risk for weight-related medical complications, particularly those with excess weight, polycystic ovary syndrome (PCOS), diabetes mellitus, or insulin resistance. The goals of the program are to introduce girls to exercise in a fun, non-threatening environment, meet other girls with similar health concerns, enable girls to discover and develop a personal enjoyment of exercise, and enable low-pressure interactions with medical care providers. The primary aim of this study is to determine changes in girls' enjoyment of exercise. Our hypothesis is that introducing girls to a fun, non-threatening environment of exercise with peer support will modify scores on a physical activity enjoyment scale. Secondary aims will assess for changes in weekly exercise, attitudes about exercise, and metabolic parameters and evidence for androgen (male hormone) excess (a precursor to PCOS). Subjects will be recruited from girls already participating in the Go Girls! program. Go Girls! is open to girls ages 10-18 yr with diagnoses of abnormal weight gain, excess weight, insulin resistance, PCOS, premature adrenarche, or type 2 diabetes mellitus previously cared for by the Pediatric Endocrinology or Children's Fitness Clinics. Questionnaire, anthropometric, and optional fasting biochemical information will be collected from girls at the beginning (first month), middle (third month), and end of a 6-month exercise/support group intervention. Assessment of the primary aim will be by comparing scores on the validated Physical Activity Enjoyment Scale (PACES) compared before, during and after the intervention. Secondary aims will be assessed via self-reported estimates of weekly exercise, qualitative written assessments of attitudes towards exercise, and changes in biochemical data. Data obtained from the questionnaire will be used to assess the primary aim of this protocol. The biochemical information, obtained via optional blood draws at the beginning, middle, and end of the 6-month exercise/support group intervention will be used to address one of the secondary aims. These blood draws are optional so as not to deter subjects from participating in the main part of the study. Data from the questionnaire and anthropometric measurements will be useful for testing the primary and some of the secondary aims of this study, regardless of whether or not fasting biochemical information is obtained.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Go Girls! Fitness Support Group | Experimental | Behavioral: Go Girls! Fitness Support Group |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Female
- Ages 10-18 yr
- Participating in the Go Girls! program
- With diagnoses of abnormal weight gain, excess weight, insulin resistance, PCOS, premature adrenarche, or type 2 diabetes mellitus
Key exclusion criteria (1 listed)
- Known pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Go Girls! Fitness Support GroupGo 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. | Behavioural | Go Girls! Fitness Support Group |
Primary outcome
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.
5 secondary outcomes
Change in mean score for the PACES scale after 3-months of intervention
Time frame: Baseline and 3 months
Change in amounts of average daily moderate-vigorous exercise
Time frame: Baseline, 3 months, and 6 months
Change in amounts of average daily vigorous exercise
Time frame: Baseline, 3 months, and 6 months
Changes in attitudes about exercise
Time frame: Baseline, 3 months, 6 months
Changes in anthropometric and biochemical indices of metabolism and possible PCOS
Time frame: Baseline, 3 months, 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christine Burt Solorzano, MD principal investigator
University of Virginia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Go Girls! Fitness Support Group in people with Polycystic Ovary Syndrome and Abnormal Weight Gain, run by University of Virginia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Melissa Gilrain (434-243-6911, pcos@virginia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in mean score for the PACES scale after 6-months of intervention (time frame: Baseline and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2023.