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PCOS (Polycystic Ovary Syndrome)Exercise and fitnessDigital healthBehavioralChildren's healthBehavioral

What this study is

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

What's being tested

  • ActiveGirls Physical Activity Program (Full)

    Intervention · BEHAVIORAL

    Participants in the ActiveGirls Full Intensity intervention group will receive a series of 6 health coaching visits delivered via telemedicine. These visits will address physical activity goal setting within the family. Participants will also receive the ActiveGirls education messaging which will include 3-4 text messages per week (Months 1-6 of their study participation).

  • ActiveGirls Physical Activity Program (Delayed Lower Intensity)

    Intervention · BEHAVIORAL

    Participants in this group will only receive the ActiveGirls education messaging which will include 3-4 text messages per week (Months 7-12 of their study participation)

Study details

Sponsor
Massachusetts General Hospital
Conditions
PCOS (Polycystic Ovary Syndrome) · Puberty · Insulin Resistance · Physical Activity
Enrolling
40 people
Starts
2025-11-24
Est. completion
2027-12
Design
Open-label, randomized, crossover
Record
View on ClinicalTrials.gov ↗