ActiveGirls: Physical Activity, Hormone Health, and Diabetes Risk in Early Adolescence
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age8+
SponsorMassachusetts General Hospital
About this trial
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
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- ActiveGirls Physical Activity Program (Full)
- ActiveGirls Physical Activity Program (Delayed Lower Intensity)
Treatment groups
40 Participants
are divided into 2 treatment groupsSponsors and collaborators
Massachusetts General Hospital
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
Source ClinicalTrials.gov