Actively Recruiting
ActiveGirls: Physical Activity, Hormone Health, and Diabetes Risk in Early Adolescence
Led by Massachusetts General Hospital · Updated on 2026-03-19
40
Participants Needed
1
Research Sites
105 weeks
Total Duration
On this page
Sponsors
M
Massachusetts General Hospital
Lead Sponsor
N
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
ActiveGirls: Physical Activity, Hormone Health, and Diabetes Risk in Early Adolescence
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Caregiver is English-speaking and has access to a device for receiving study emails or texts
- Child is English-speaking, female, and between 8 and 12 years old at enrollment
- Child is pre-menarchal at baseline visit
- Child is at risk for PCOS or insulin resistance, defined by at least one of: maternal history of PCOS or gestational diabetes, BMI at or above 85th percentile, history of premature adrenarche, or small for gestational age (below 10th percentile)
You will not qualify if you...
- Child is taking Metformin, GLP-1R agonist, insulin, or GnRH agonist at enrollment
- Child has endocrine conditions affecting insulin sensitivity, androgen levels, or growth
- Child has type 1 or type 2 diabetes or congenital hyperinsulinism
- Child has adrenal tumors or congenital adrenal hyperplasia
- Child has hyperthyroidism or uncontrolled hypothyroidism (TSH >7.0 mIU/mL)
- Child has growth hormone deficiency
- Child has medical conditions limiting physical activity participation such as cardiovascular, neurological, or musculoskeletal disorders
- Child has severe congenital heart disease, congenital anomalies, cystic fibrosis, cerebral palsy, or requires alternative feeding methods
- Child has undiagnosed conditions significantly affecting growth or development
- Child has significant cardiac, liver, cancerous, inflammatory, or psychiatric diseases
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Massachusetts General Hospital
Somerville, Massachusetts, United States, 02144
Actively Recruiting
Research Team
R
Rachel Whooten, MD MPH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
PREVENTION
Number of Arms
2
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