Trial NCT07102797
ActiveGirls: Physical Activity, Hormone Health, and Diabetes Risk in Early Adolescence
- Phase
- Not given
- Sponsor
- Massachusetts General Hospital
- Conditions
- PCOS (Polycystic Ovary Syndrome); Puberty; Insulin Resistance; Physical Activity
- Ages
- 8+ years
Eligibility criteria
Highlighted: restrictions our model extracted, each a verbatim quote (pink = excludes outright, blue = only under conditions).
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 textsLanguage
* Child: English-speaking, Female, ages 8-12 years old at time of enrollmentAge, 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 percentileBMI, (3) History of premature adrenarche, or (4) Small (<10th %ile) for gestational age
Exclusion Criteria (Child):
* 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 HyperinsulinismDiabetes
* 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.Cardiac · Hepatic
Restrictions found (6)
- AgeOutrightinclusion
age 8-12 years
Show in the text - BMIConditionalinclusion
BMI >= 85th percentile
Show in the text - CardiacOutrightexclusionShow in the text
- DiabetesOutrightexclusionShow in the text
- HepaticOutrightexclusionShow in the text
- LanguageOutrightinclusionShow in the text
Recruiting in Massachusetts
- Massachusetts General Hospital · Somerville, Middlesex County