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

Recruiting now · Not applicable

Conditions studied: PCOS (Polycystic Ovary Syndrome), Puberty, Insulin Resistance, Physical Activity

In brief

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

Key facts

Study ID

NCT07102797

Run by

Massachusetts General Hospital

People needed

40

Starts

2025-11-24

Expected to finish

2027-12-01

Last updated by the study team

2026-03-19

Who can join

Age: 8 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify 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 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.

Where it is running

• Massachusetts General Hospital — Somerville, Massachusetts, United States (enrolling)

Full record on ClinicalTrials.gov

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