What this study is
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
What's being tested
- ActiveGirls Physical Activity Program (Full)
Intervention · BEHAVIORAL
Participants in the ActiveGirls Full Intensity intervention group will receive a series of 6 health coaching visits delivered via telemedicine. These visits will address physical activity goal setting within the family. Participants will also receive the ActiveGirls education messaging which will include 3-4 text messages per week (Months 1-6 of their study participation).
- ActiveGirls Physical Activity Program (Delayed Lower Intensity)
Intervention · BEHAVIORAL
Participants in this group will only receive the ActiveGirls education messaging which will include 3-4 text messages per week (Months 7-12 of their study participation)
Study details
- Sponsor
- Massachusetts General Hospital
- Conditions
- PCOS (Polycystic Ovary Syndrome) · Puberty · Insulin Resistance · Physical Activity
- Enrolling
- 40 people
- Starts
- 2025-11-24
- Est. completion
- 2027-12
- Design
- Open-label, randomized, crossover
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 8 Years and overSex FEMALEHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openMassachusetts General Hospital
Somerville, Massachusetts, United States
- Rachel Whooten · Contactrwhooten@mgh.harvard.edu
- Rachel Whooten · Principal investigator
Recruiting
Study team
Sponsor
Massachusetts General Hospital
Study ID 2025P001307
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.