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

NCT ID: NCT07102797

Last Updated: 2025-11-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-31
• Study Completion Date: 2027-12-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

ActiveGirls Physical Activity Program (Full)

Intervention Type: 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).

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.

Group Type: ACTIVE_COMPARATOR

ActiveGirls Physical Activity Program (Delayed Lower Intensity)

Intervention Type: 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)

Interventions

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).

Intervention Type: 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)

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• Medications at time of enrollment: Metformin, GLP-1R Agonist, Insulin, GnRH agonist
• Endocrine conditions that would impact either insulin sensitivity, androgen concentrations, or growth
• Insulin dynamics: Type 1 diabetes, Type 2 diabetes, Congenital Hyperinsulinism
• Androgen Conditions: Adrenal tumor, Congenital Adrenal Hyperplasia
• Hyperthyroidism or uncontrolled hypothyroidism (TSH >7.0 mIU/mL)
• Growth Hormone Deficiency
• Medical conditions that would impact PA participation: Type 1 diabetes; Cardiovascular, neurologic, and/or musculoskeletal conditions limiting ability to participate in physical activity.
• Other medical comorbidities that would limit generalizability of findings, including: Severe congenital heart disease, Congenital anomalies, Cystic fibrosis, Cerebral palsy, Condition requiring use of nasogastric, gastric tube, or other alternative method of feeding, Undiagnosed conditions with significant impact on child's growth and development; Significant cardiac, hepatic, oncologic, inflammatory, or psychiatric disease.

• Minimum Eligible Age: 8 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

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

NIH

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Rachel Clare Whooten

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Massachusetts General Hospital

Somerville, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Rachel Whooten, MD MPH

Role: CONTACT

rwhooten@mgh.harvard.edu

6176434585

Facility Contacts

Rachel Whooten

Role: primary

rwhooten@mgh.harvard.edu

Other Identifiers

5K23DK131322

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2025P001307

Identifier Type: -

Identifier Source: org_study_id