|

ActiveGirls: Physical Activity, Hormone Health, and Diabetes Risk in Early Adolescence

RECRUITINGN/ASponsored by Massachusetts General Hospital
Actively Recruiting
PhaseN/A
SponsorMassachusetts General Hospital
Started2025-12
Est. completion2027-12
Eligibility
Age8 Years+
SexFEMALE
Healthy vol.Accepted
Locations1 site

Summary

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? * What is the trend of markers of diabetes risk and puberty hormones over a 1-year period and how are these levels related to physical activity levels? Participants in this study will either: * Participate in a 'full' intensity intervention that includes educational messages (text/email) as well as health coaching visits to support physical activity over a 6 month period * Participate in a delayed 'lower intensity' intervention that includes only educational messages (text/email) * Participants in both groups will complete at-home activity monitoring, two study visits for check-ups and tests, and surveys

Eligibility

Age: 8 Years+Sex: FEMALEHealthy volunteers accepted
Inclusion 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 PCOS/maternal GDM, (2) BMI \>/= 85th percentile, (3) History of premature adrenarche, or (4) Small (\<10th %ile) for gestational age

Exclusion Criteria (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, gastric tube, or other alternative method of feeding, Undiagnosed conditions with significant impact on child's growth and development; Significant cardiac, hepatic, oncologic, inflammatory, or psychiatric disease.

Conditions6

CancerDiabetesInsulin ResistancePCOS (Polycystic Ovary Syndrome)Physical ActivityPuberty

Locations1 site

Massachusetts General Hospital
Somerville, Massachusetts, 02144

Browse More Trials

Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

This site does not provide medical advice. Always consult your doctor before considering enrollment in a clinical trial. Learn more on our About page.