PCOS (Polycystic Ovary Syndrome)NCT07102797
ActiveGirls: Physical Activity, Hormone Health, and Diabetes Risk in Early Adolescence
A study testing ActiveGirls Physical Activity Program (Full) and ActiveGirls Physical Activity Program (Delayed Lower Intensity) in people with PCOS (Polycystic Ovary Syndrome) and Puberty, run by Massachusetts General Hospital at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 8 years and older, women only
- Conditions the study is for
- PCOS (Polycystic Ovary Syndrome), Puberty, Insulin Resistance
- What is being tested?
- ActiveGirls Physical Activity Program (Full) and ActiveGirls Physical Activity Program (Delayed Lower Intensity)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Nov 2025to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Massachusetts General Hospital
Somerville, Massachusetts, 02144
Rachel Whooten, rwhooten@mgh.harvard.edu
Rachel Whooten
About this study
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?
Read more
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
Read the 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.
- Being tested
- ActiveGirls Physical Activity Program (Full), ActiveGirls Physical Activity Program (Delayed Lower Intensity)
- Keywords
- PCOS, Prevention, Physical Activity
- Medical subject headings
- Polycystic Ovary Syndrome, Insulin Resistance, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ActiveGirls Physical Activity Program (Full)Behavioural
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)Behavioural
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 group | Role | What they receive |
|---|---|---|
| Full Intensity Intervention | Experimental | 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. Receives: Behavioral: ActiveGirls Physical Activity Program (Full) |
| Delayed lower intensity comparison group | Active comparator | 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. Receives: Behavioral: ActiveGirls Physical Activity Program (Delayed Lower Intensity) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention
Proportion of participants completing each study assessment point/coaching visit divided by total participants enrolled/eligible
Measured: 12 months
Acceptability
Intervention rating as acceptable by parent-child dyads using validated measure (Acceptability of Intervention Measure (AIM)); The AIM score is reported on a scale of 0-4. 0 is the minimum and 4 is the maximum. Higher scores mean greater intervention acceptability
Measured: 12 months
Secondary outcomes (3)
Objectively Measured Physical Activity
Change in MVPA (minutes/day) from baseline to 6-month and 12-month follow-up
Measured: 6 months, 12 months
Insulin Sensitivity
As measured by HOMA-IR (unitless; calculated based on product of fasting insulin and fasting glucose using standardized formula)
Measured: Change in HOMA-IR from baseline to 12-month follow-up
Free Androgen Index
Calculated using Total Testosterone and SHBG
Measured: Baseline to 12 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2025
- Study start24 Nov 2025
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PCOS (Polycystic Ovary Syndrome)Studies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Participants will be assigned to the intensive intervention group with text messaging and health coaching versus a delayed lower intensity comparison group with a lower intensity text-only intervention.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rachel Clare Whooten, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07102797
- Sponsor's protocol ID
- 2025P001307
- Other IDs
- 5K23DK131322
- Status last verified
- Mar 2026
- First submitted
- 30 Jul 2025
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ActiveGirls: Physical Activity, Hormone Health, and Diabetes Risk in Early Adolescence
- ClinicalTrials.gov ID
- NCT07102797
- Acronym / sponsor ID
- 2025P001307
- Keywords
- PCOS, Prevention, Physical Activity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 24 Nov 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 5 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be assigned to the intensive intervention group with text messaging and health coaching versus a delayed lower intensity comparison group with a lower intensity text-only intervention.
| Arm | Type | Receives |
|---|---|---|
| Full Intensity Intervention | Experimental | Behavioral: ActiveGirls Physical Activity Program (Full)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. |
| Delayed lower intensity comparison group | Active comparator | Behavioral: ActiveGirls Physical Activity Program (Delayed Lower Intensity)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. |
Who may qualify
- Ages
- 8 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Behavioural | Full Intensity Intervention |
| 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) | Behavioural | Delayed lower intensity comparison group |
Primary outcome
Retention
Time frame: 12 months
Proportion of participants completing each study assessment point/coaching visit divided by total participants enrolled/eligible
Acceptability
Time frame: 12 months
Intervention rating as acceptable by parent-child dyads using validated measure (Acceptability of Intervention Measure (AIM)); The AIM score is reported on a scale of 0-4. 0 is the minimum and 4 is the maximum. Higher scores mean greater intervention acceptability
3 secondary outcomes
Objectively Measured Physical Activity
Time frame: 6 months, 12 months
Insulin Sensitivity
Time frame: Change in HOMA-IR from baseline to 12-month follow-up
Free Androgen Index
Time frame: Baseline to 12 month follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ActiveGirls Physical Activity Program (Full) and ActiveGirls Physical Activity Program (Delayed Lower Intensity) in people with PCOS (Polycystic Ovary Syndrome) and Puberty, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rachel Whooten, MD MPH (6176434585, rwhooten@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retention (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026.