ActiveGirls Study Increasing Physical Activity to Support Hormone Health and Reduce Diabetes Risk in Girls Ages 8 to 12

What this Trial Is About

Researchers are investigating how a physical activity program affects hormone health and diabetes risk in girls aged 8 to 12 who may be at higher risk for conditions like Polycystic Ovary Syndrome PCOS and insulin resistance. This pilot randomized trial aims to evaluate whether the ActiveGirls program effectively engages girls and their families to increase physical activity and to track changes in markers of diabetes risk and puberty hormones over one year. Participants are randomly assigned to either a full intensity intervention group or a delayed lower intensity comparison group. The full intensity group receives 3-4 educational messages per week via text or email and six health coaching visits via telemedicine during the first six months. The delayed lower intensity group receives only the educational messages during months 7 to 12. Both groups complete at-home activity monitoring and participate in study visits for health assessments. Participants will have baseline and 12-month in-person visits at the research center, with a remote assessment at 6 months. These visits include checks on body composition, insulin sensitivity, reproductive hormones, and physical fitness. Surveys about lifestyle behaviors and social-emotional wellness are completed by both participants and a caregiver. The study measures retention, acceptability, physical activity levels, insulin sensitivity changes, and hormone levels over the year-long participation period.

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