ActiveGirls: Physical Activity, Hormone Health, and Diabetes Risk in Early Adolescence
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age8+
SponsorMassachusetts General Hospital
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Crossover
Treatments tested in this trial
ActiveGirls Physical Activity Program (Full)
BehavioralParticipants 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)
BehavioralParticipants 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)
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Full Intensity InterventionExperimental treatment 1 intervention
Group B: Delayed lower intensity comparison groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Retention
Proportion of participants completing each study assessment point/coaching visit divided by total participants enrolled/eligible
Time frame
12 months2
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
Time frame
12 monthsSecondary outcomes
1
Objectively Measured Physical Activity
Change in MVPA (minutes/day) from baseline to 6-month and 12-month follow-up
Time frame
6 months, 12 months2
Insulin Sensitivity
As measured by HOMA-IR (unitless; calculated based on product of fasting insulin and fasting glucose using standardized formula)
Time frame
Change in HOMA-IR from baseline to 12-month follow-up3
Free Androgen Index
Calculated using Total Testosterone and SHBG
Time frame
Baseline to 12 month follow-upSponsors and contacts
Click on the lead sponsor to view all of their trials.
Massachusetts General Hospital
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
Source ClinicalTrials.gov