Status:

RECRUITING

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

Lead Sponsor:

Massachusetts General Hospital

Collaborating Sponsors:

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Conditions:

PCOS (Polycystic Ovary Syndrome)

Puberty

Eligibility:

FEMALE

8+ years

Phase:

NA

Brief 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' progr...

Detailed Description

This study is a pilot randomized trial to assess the preliminary feasibility and efficacy of a physical activity intervention enrolling peripubertal females. Participants will be assigned to the inte...

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.

Key Trial Info

Start Date :

November 24 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 1 2027

Estimated Enrollment :

40 Patients enrolled

Trial Details

Trial ID

NCT07102797

Start Date

November 24 2025

End Date

December 1 2027

Last Update

March 19 2026

Active Locations (1)

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1

Massachusetts General Hospital

Somerville, Massachusetts, United States, 02144