ActiveGirls physical activity program for hormone health and diabetes-risk prevention in girls ages 8–12

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a pilot randomized trial enrolling premenarchal girls ages 8–12 who are at elevated risk for PCOS or insulin resistance. Participants are randomized to a full-intensity intervention with health coaching plus educational texts/emails or a delayed, lower-intensity text-only intervention, with caregiver involvement to support at-home activity. Both groups complete objective measures of body composition, insulin dynamics, reproductive hormones, fitness, and continuous activity monitoring, plus surveys at baseline, 6 months, and 12 months. Baseline and 12-month visits are in person at the MGH Translational and Clinical Research Centers and the 6-month assessment is remote.

Why it matters

Who can join: the full rules

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.

Where it's running

• Massachusetts General Hospital
  Somerville, Massachusetts, United States Recruiting

Study contacts

• Study coordinator: Rachel Whooten, MD MPH
• Email: rwhooten@mgh.harvard.edu
• Phone: 6176434585

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.