Recruiting

ActiveGirls

Sponsor:

Massachusetts General Hospital

Code:

NCT07102797

Conditions

PCOS (Polycystic Ovary Syndrome)

Puberty

Insulin Resistance

Physical Activity

Eligibility Criteria

Sex: Female

Age: 8+

Healthy Volunteers: Not accepted

Interventions

ActiveGirls Physical Activity Program (Full)

ActiveGirls Physical Activity Program (Delayed Lower Intensity)

Study Details

Brief summary:

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

PCOS (Polycystic Ovary Syndrome)

Puberty

Insulin Resistance

Physical Activity

Study ID

NCT07102797

Start date

Nov 24, 2025

Status verified date

Mar, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 8+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Full Intensity Intervention

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.

active comparator: Delayed lower intensity comparison group

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.

Interventions

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).

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 measure

  • Retention [ Time Frame: 12 months ]
  • Acceptability [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Rachel Whooten, MD MPH

6176434585rwhooten@mgh.harvard.edu

Locations

Massachusetts General Hospital

Recruiting

Somerville, Massachusetts, United States, 02144

Contacts

Rachel Whooten

rwhooten@mgh.harvard.edu

Principal Investigator:

Rachel Whooten

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Mar 19, 2026

Last verified

Mar, 2026

Keywords

  • PCOS
  • Prevention
  • Physical Activity

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2026-03-19.