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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 8
Healthy Volunteers: f
View:

• 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

Locations
United States
Massachusetts
Massachusetts General Hospital
RECRUITING
Somerville
Contact Information
Primary
Rachel Whooten, MD MPH
rwhooten@mgh.harvard.edu
6176434585
Time Frame
Start Date: 2025-12
Estimated Completion Date: 2027-12
Participants
Target number of participants: 40
Treatments
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.
Sponsors
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Leads: Massachusetts General Hospital

This content was sourced from clinicaltrials.gov

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