NCT07102797

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: Female
• Age: 8 Years
• Healthy volunteers: Not accepted

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

Detailed description

This study is a pilot randomized trial to assess the preliminary feasibility and efficacy of a physical activity intervention enrolling peripubertal females. Participants will be assigned to the intensive intervention group with text messaging and health coaching versus delayed lower intensity comparison group with a lower intensity text-only intervention. Participants in both arms will complete objective measures of body composition, insulin dynamics, reproductive hormones, physical activity and fitness over a one-year period. Participants as well as a caregiver proxy will complete survey measures addressing lifestyle behaviors and social-emotional wellness. Given evidence suggesting increased effectiveness of whole-family lifestyle interventions, a parent/caregiver will assist with child participation in the ActiveGirls program, including facilitating health coaching visits and at-home physical activity sessions. assist in intervention delivery and outcomes assessment. After the baseline visit, there are 2 more study assessment points at 6-months and 12-months. The baseline and 12-month assessments require in-person visits to the MGH Translational and Clinical Research Centers (TCRC); the 6-month assessment is performed remotely. All study visits will occur at MGH.

Conditions

• PCOS (Polycystic Ovary Syndrome)
• Puberty
• Insulin Resistance
• Physical Activity

Interventions

Type	Name	Description
BEHAVIORAL	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).
BEHAVIORAL	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)

Timeline

• Start date: 2025-11-24
• Primary completion: 2027-12-01
• Completion: 2027-12-01
• First posted: 2025-08-05
• Last updated: 2026-03-19

Locations

1 site across 1 country: United States