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RECRUITING
NCT07102797
NA

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

Sponsor: Massachusetts General Hospital

View on ClinicalTrials.gov

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

Key Details

Gender

FEMALE

Age Range

8 Years - Any

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2025-11-24

Completion Date

2027-12

Last Updated

2026-03-19

Healthy Volunteers

No

Interventions

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)

Locations (1)

Massachusetts General Hospital

Somerville, Massachusetts, United States