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

NCT07102797 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-03-19

No results posted yet for this study

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

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)

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH

  • Massachusetts General Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
8 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-24
Primary Completion
2027-12-31
Completion
2027-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07102797 on ClinicalTrials.gov