ActiveGirls: Physical Activity, Hormone Health, and Diabetes Risk in Early Adolescence

NCT07102797 | Recruiting DMC

• 2 other identifiers: 2025P0013075K23DK131322
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Keywords

PCOS; Prevention; Physical Activity

Outcome Measures

Primary Outcomes (2)

• Retention

  Proportion of participants completing each study assessment point/coaching visit divided by total participants enrolled/eligible

  12 months

• Acceptability

  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

  12 months

Secondary Outcomes (3)

• Objectively Measured Physical Activity

  6 months, 12 months

• Insulin Sensitivity

  Change in HOMA-IR from baseline to 12-month follow-up

• Free Androgen Index

  Baseline to 12 month follow-up

Study Arms (2)

Full Intensity Intervention

EXPERIMENTAL

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.

Behavioral: ActiveGirls Physical Activity Program (Full)

Delayed lower intensity comparison group

ACTIVE COMPARATOR

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.

Behavioral: ActiveGirls Physical Activity Program (Delayed Lower Intensity)

Interventions

ActiveGirls Physical Activity Program (Full) BEHAVIORAL

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).

Full Intensity Intervention

ActiveGirls Physical Activity Program (Delayed Lower Intensity) BEHAVIORAL

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)

Delayed lower intensity comparison group

Eligibility Criteria

• Age: 8 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Massachusetts General Hospital

Somerville, Massachusetts, 02144, United States

RECRUITING

MeSH Terms

Conditions

Polycystic Ovary Syndrome; Insulin Resistance; Motor Activity

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Behavior

Central Study Contacts

Rachel Whooten, MD MPH

CONTACT

6176434585; rwhooten@mgh.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Participants will be assigned to the intensive intervention group with text messaging and health coaching versus a delayed lower intensity comparison group with a lower intensity text-only intervention.

Study Record Dates

• First Submitted: July 30, 2025
• First Posted: August 5, 2025
• Study Start: November 24, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 19, 2026

Record last verified: 2026-03

Locations

US (1)