NCT07102797 · Massachusetts General Hospital
ActiveGirls: Physical Activity, Hormone Health, and Diabetes Risk in Early Adolescence
What this study 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.
View original scientific description
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.
Interventions
BEHAVIORAL
ActiveGirls Physical Activity Program (Full)
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).
BEHAVIORAL
ActiveGirls Physical Activity Program (Delayed Lower Intensity)
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)
Primary outcome measures
Retention
Time frame: 12 months
Proportion of participants completing each study assessment point/coaching visit divided by total participants enrolled/eligible
Acceptability
Time frame: 12 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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 criteria
- 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.
Where
- Somerville, Massachusetts
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 19, 2026 · Source of record for eligibility and locations