Clinical Trial

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

Recruiting
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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
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2025-07-30; most recent amendment 2026-03-17.
Status change: Not Yet Recruiting → Recruiting 2025-11-20
Trial Details
NCT Number NCT07102797
Lead Sponsor Massachusetts General Hospital
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions PCOS (Polycystic Ovary Syndrome), Puberty, Insulin Resistance, Physical Activity
Enrollment 40 participants
Start Date 2025-11-24
Primary Completion 2027-12 (estimated)
Study Completion 2027-12 (estimated)
Updated on ClinicalTrials.gov 2026-03-19