NCT07102797Recruiting
ActiveGirls: Physical Activity, Hormone Health, and Diabetes Risk in Early Adolescence
Source: ClinicalTrials.gov · Last updated 19 Mar 2026
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 30 Jul 2025
- Start date
- 24 Nov 2025
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- Massachusetts General Hospital
- NCT number
- NCT07102797
What you commit to
- Study type: Interventional
- Planned participants: 40
- From 24 Nov 2025 to the primary completion date, 31 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Medications at time of enrollment: Metformin, GLP-1R Agonist, Insulin, GnRH agonist
Other illness
- 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
- 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.
Other
- Hyperthyroidism or uncontrolled hypothyroidism (TSH \>7.0 mIU/mL)
- Growth Hormone Deficiency
Who the study is looking for
- 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
Age in the registry: 8 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Massachusetts General Hospital Coordinator of this site? Confirm its status | Somerville | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.