Clinical trial · Interventional
ActiveGirls: Physical Activity, Hormone Health, and Diabetes Risk in Early Adolescence
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Insulin Resistance | — | UNRESOLVED | — |
| PCOS (Polycystic Ovary Syndrome) | — | UNRESOLVED | — |
| Physical Activity | — | UNRESOLVED | — |
| Puberty | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ActiveGirls Physical Activity Program (Delayed Lower Intensity) | Behavioral | — | UNRESOLVED |
| ActiveGirls Physical Activity Program (Full) | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Full Intensity Intervention
- description
- Participants in this arm will receive the 'full' intensive ActiveGirls intervention, which will include educational messaging (3-4/week, via email or text message) as well as a series of 6 health coaching visits for physical activity goal setting. Participants in this arm will receive the intervention in months 1-6 of their study participation.
- interventionNames
- Behavioral: ActiveGirls Physical Activity Program (Full)
- type
- ACTIVE_COMPARATOR
- label
- Delayed lower intensity comparison group
- description
- Participants in this arm will receive a lower intensity educational messaging only intervention in months 7-12 of their study participation. This group will not receive health coaching.
- interventionNames
- Behavioral: ActiveGirls Physical Activity Program (Delayed Lower Intensity)
Primary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 8 Years
Show eligibility criteria text
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 (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 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.
References
Publications (0)
Data not yet available