ActiveGirls physical activity program for hormone health and diabetes-risk prevention in girls ages 8–12
ActiveGirls: Physical Activity, Hormone Health, and Diabetes Risk in Early Adolescence
NA · Massachusetts General Hospital · NCT07102797
This study will test whether a 6-month ActiveGirls program with coaching and messages helps girls ages 8–12 improve hormone health and lower markers of diabetes risk compared with a lower-intensity, delayed program.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 8 Years and up |
| Sex | Female |
| Sponsor | Massachusetts General Hospital (other) |
| Locations | 1 site (Somerville, Massachusetts) |
| Trial ID | NCT07102797 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Girls ages 8–12 who are premenarchal and at increased risk for PCOS or insulin resistance (for example due to BMI ≥85th percentile, maternal PCOS/GDM, premature adrenarche, or being small for gestational age) and who have a caregiver able to participate are ideal candidates.
Not a fit: Girls who are post-menarche, have diagnosed type 1 or type 2 diabetes, other endocrine conditions that affect insulin or androgens, or who are taking medications such as metformin, GLP-1 receptor agonists, insulin, or GnRH agonists are unlikely to benefit from this program.
Why it matters
Potential benefit: If successful, the program could help at-risk girls increase physical activity, improve hormone balance, and reduce early markers of diabetes risk.
How similar studies have performed: Some family-based lifestyle and physical activity programs have improved weight and metabolic markers in youth, but interventions specifically targeting peripubertal prevention of PCOS and insulin resistance are limited and this pilot is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Somerville, Massachusetts
- Massachusetts General Hospital — Somerville, Massachusetts, United States (RECRUITING)
Study contacts
- Study coordinator: Rachel Whooten, MD MPH
- Email: rwhooten@mgh.harvard.edu
- Phone: 6176434585
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: PCOS, Puberty, Insulin Resistance, Physical Activity, Prevention