ActiveGirls: Physical Activity, Hormone Health, and Diabetes Risk in Early Adolescence

This study, called ActiveGirls, is looking at how a physical activity program can help girls aged 8-12 who might be at higher risk for Polycystic Ovary Syndrome (PCOS) and insulin resistance (a condition where your body doesn't use insulin properly, which can lead to type 2 diabetes). Researchers want to see if the 'ActiveGirls' program helps families get more active and how physical activity affects hormones and diabetes risk over one year. You would either join a group that gets health coaching and educational messages, or a group that gets educational messages later on. The study is currently unclear on its status and plans to enroll 40 participants.

Study design
This is a pilot randomized trial with 40 participants. You would be assigned to one of two groups: an intensive intervention group or a delayed lower intensity comparison group.
What's involved
You would have in-person visits at MGH at the start and after 12 months, and a remote visit after 6 months. A caregiver would also help with your participation.
Compensation
Not stated in the trial record.
Follow-up
Your progress will be assessed at 6 months and 12 months after the start of the study.

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NCT07102797

ActiveGirls: Physical Activity, Hormone Health, and Diabetes Risk in Early Adolescence

Recruiting
NAAges 8+InterventionalPrevention
Massachusetts General Hospital
~40 participants
Updated 2026-03-19 on ClinicalTrials.gov
What's tested:ActiveGirls Physical Activity Program (Full)ActiveGirls Physical Activity Program (Delayed Lower Intensity)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Retention
Measured over 12 months
+1 more outcome measured
PCOS (Polycystic Ovary Syndrome)
Puberty
Insulin Resistance
Physical Activity
1 sites across 1 states
Massachusetts1

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Eligibility criteria

Inclusion

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

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.
  • Retention12 months

    Proportion of participants completing each study assessment point/coaching visit divided by total participants enrolled/eligible

  • Acceptability12 months

    Intervention rating as acceptable by parent-child dyads using validated measure (Acceptability of Intervention Measure (AIM)); The AIM score is reported on a scale of 0-4. 0 is the minimum and 4 is the maximum. Higher scores mean greater intervention acceptability