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

Part of paid clinical trials in Somerville, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT07102797
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
FEMALE
Age
8 Years - N/A
Healthy Volunteers
Not accepted

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).
  • 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)

Study Details

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 Dates

Start date
Nov 24, 2025
Status verified
Mar 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION

Arms

  • 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.

Primary Outcome Measure

Retention [ Time Frame: 12 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Massachusetts General HospitalSomervilleMassachusetts02144
Rachel Whooten
[email protected]
Rachel Whooten (PRINCIPAL_INVESTIGATOR)

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Massachusetts General Hospital· Somerville, MA

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