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New treatment option for PCOS (Polycystic Ovary Syndrome)
Official title ActiveGirls: Physical Activity, Hormone Health, and Diabetes Risk in Early Adolescence
ClinicalTrials.gov ID: NCT07102797
What this study is testing
- What it's testing
- This study explores how a physical activity program can affect hormone health and diabetes risk in girls ages 8-12 who may be at higher risk. The study aims to address: Does the 'ActiveGirls' program meet the needs of girls and families in engaging them to increase physical activity?
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 8 and older, women only
You may be able to join if
- Caregiver: Caregiver of child (ie mother, father, or other legal guardian), English-speaking, Access to a device where they are able to receive study...
- Child: English-speaking, Female, ages 8-12 years old at time of enrollment, Pre-menarchal at time of baseline visit, at risk for Polycystic Ovary...
You likely can't join if
- (Child):
- Medications at time of enrollment: Metformin, GLP-1R Agonist, Insulin, GnRH agonist
- Endocrine conditions that would impact either insulin sensitivity, androgen concentrations, or growth
- Insulin dynamics: Type 1 diabetes, Type 2 diabetes, Congenital Hyperinsulinism
- Androgen Conditions: Adrenal tumor, Congenital Adrenal Hyperplasia
- Hyperthyroidism or uncontrolled hypothyroidism (TSH \>7.0 mIU/mL)
See the full eligibility criteria
- Caregiver: Caregiver of child (ie mother, father, or other legal guardian), English-speaking, Access to a device where they are able to receive study e-mails or texts
- Child: English-speaking, Female, ages 8-12 years old at time of enrollment, Pre-menarchal at time of baseline visit, at risk for Polycystic Ovary Syndrome (PCOS)/insulin resistance, as defined by (1) History of maternal...
- (Child):
- Medications at time of enrollment: Metformin, GLP-1R Agonist, Insulin, GnRH agonist
- Endocrine conditions that would impact either insulin sensitivity, androgen concentrations, or growth
- Insulin dynamics: Type 1 diabetes, Type 2 diabetes, Congenital Hyperinsulinism
- Androgen Conditions: Adrenal tumor, Congenital Adrenal Hyperplasia
- Hyperthyroidism or uncontrolled hypothyroidism (TSH \>7.0 mIU/mL)
- Growth Hormone Deficiency
- Medical conditions that would impact PA participation: Type 1 diabetes; Cardiovascular, neurologic, and/or musculoskeletal conditions limiting ability to participate in physical activity.
- Other medical comorbidities that would limit generalizability of findings, including: Severe congenital heart disease, Congenital anomalies, Cystic fibrosis, Cerebral palsy, Condition requiring use of nasogastric...
The study team makes the final eligibility decision.
Where it's taking place
- Somerville, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 8 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Somerville, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.