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Search / Trial NCT07102797

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

Launched by MASSACHUSETTS GENERAL HOSPITAL · Jul 30, 2025

Trial Information

Current as of August 19, 2025

Not yet recruiting

Keywords

Pcos Prevention Physical Activity

ClinConnect Summary

This study, called ActiveGirls, is looking at how a special physical activity program might help girls aged 8 to 12 who are at higher risk for a condition called Polycystic Ovary Syndrome (PCOS) and early signs of diabetes. The researchers want to see if this program can encourage girls to be more active and if being active can positively affect hormones related to puberty and the risk of developing diabetes over the course of a year.

Girls who join the study will either take part in a more involved program that includes health coaching and supportive messages for six months, or they will receive just the educational messages and start the coaching later. All participants will wear activity monitors at home, visit the study team twice for check-ups and tests, and complete surveys. To join, girls need to be between 8 and 12 years old, not yet started their periods, and have certain risk factors like a family history of PCOS or higher body weight. Caregivers must be able to receive emails or texts in English. The study excludes girls with certain health conditions or on specific medications. This research aims to better understand how physical activity can support hormone health and reduce diabetes risk during early adolescence.

Gender

FEMALE

Eligibility criteria

  • 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.

About Massachusetts General Hospital

Massachusetts General Hospital (MGH) is a leading academic medical center located in Boston, Massachusetts, renowned for its commitment to advancing medical research and patient care. As a prominent teaching hospital affiliated with Harvard Medical School, MGH plays a pivotal role in clinical trials across a wide range of disciplines, including cardiology, oncology, neurology, and more. The institution is dedicated to fostering innovative research that translates into effective therapies and improved health outcomes. MGH's Clinical Trials Office provides comprehensive support to facilitate the design, implementation, and management of clinical studies, ensuring adherence to the highest ethical standards and regulatory compliance. With a focus on collaboration and patient-centered care, MGH strives to enhance medical knowledge and contribute to the future of healthcare.

Locations

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported