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
N/A
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
Researchers are investigating how a physical activity program affects hormone health and diabetes risk in girls aged 8 to 12 who may be at higher risk for conditions like Polycystic Ovary Syndrome (PCOS) and insulin resistance. This pilot randomized trial aims to evaluate whether the ActiveGirls program effectively engages girls and their families to increase physical activity and to track changes in markers of diabetes risk and puberty hormones over one year. Participants are randomly assigned to either a full intensity intervention group or a delayed lower intensity comparison group. The full intensity group receives 3-4 educational messages per week via text or email and six health coaching visits via telemedicine during the first six months. The delayed lower intensity group receives only the educational messages during months 7 to 12. Both groups complete at-home activity monitoring and participate in study visits for health assessments. Participants will have baseline and 12-month in-person visits at the research center, with a remote assessment at 6 months. These visits include checks on body composition, insulin sensitivity, reproductive hormones, and physical fitness. Surveys about lifestyle behaviors and social-emotional wellness are completed by both participants and a caregiver. The study measures retention, acceptability, physical activity levels, insulin sensitivity changes, and hormone levels over the year-long participation period.
CONDITIONS
Brief Title
ActiveGirls: Physical Activity, Hormone Health, and Diabetes Risk in Early Adolescence
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Caregiver is an English-speaking parent or legal guardian with access to a device for study emails or texts
- Child is an English-speaking female aged 8 to 12 years at enrollment
- Child is pre-menarchal at baseline visit
- Child is at risk for PCOS or insulin resistance, defined by one or more of: maternal PCOS or gestational diabetes history, BMI at or above 85th percentile, premature adrenarche history, or small size for gestational age (below 10th percentile)
You will not qualify if you...
- Child is taking Metformin, GLP-1R agonists, 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, congenital hyperinsulinism, adrenal tumor, 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, including cardiovascular, neurological, or musculoskeletal disorders
- Child has other serious medical conditions such as severe congenital heart disease, congenital anomalies, cystic fibrosis, cerebral palsy, need for alternative feeding methods, undiagnosed growth-impacting conditions, or significant cardiac, hepatic, oncologic, inflammatory, or psychiatric diseases
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants complete baseline measures of body composition, insulin dynamics, reproductive hormones, physical activity, fitness, and surveys on lifestyle and social-emotional wellness. A caregiver assists in the assessments and intervention facilitation.
1 visit (in-person)
Duration - 12 months
Participants receive either the full intensity ActiveGirls physical activity program with 6 health coaching visits via telemedicine and educational messaging (3-4 texts per week) during months 1-6, or a delayed lower intensity educational messaging intervention during months 7-12.
6 health coaching visits via telemedicine (months 1-6) and ongoing text messages; caregiver assists with participation
Duration - 1 day
Participants complete study assessments remotely, including objective physical activity and survey measures.
1 remote visit
Duration - 1 day
Participants complete final in-person assessments of body composition, insulin dynamics, reproductive hormones, physical activity, fitness, and surveys with caregiver assistance.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
Massachusetts General Hospital
Somerville, Massachusetts, United States, 02144
Actively Recruiting
Research Team
R
Rachel Whooten, MD MPH
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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