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| ID | Type | Description | Link |
|---|---|---|---|
| 5K23DK131322 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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:
Participants in this study will either:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Retention | Proportion of participants completing each study assessment point/coaching visit divided by total participants enrolled/eligible | 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 | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Objectively Measured Physical Activity | Change in MVPA (minutes/day) from baseline to 6-month and 12-month follow-up | 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) |
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Inclusion Criteria:
Exclusion Criteria (Child):
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rachel Whooten, MD MPH | Contact | 6176434585 | rwhooten@mgh.harvard.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Recruiting | Somerville | Massachusetts | 02144 | United States |
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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.
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| 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) |
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| Change in HOMA-IR from baseline to 12-month follow-up |
| Free Androgen Index | Calculated using Total Testosterone and SHBG | Baseline to 12 month follow-up |
| ID | Term |
|---|---|
| D011085 | Polycystic Ovary Syndrome |
| D007333 | Insulin Resistance |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D010048 | Ovarian Cysts |
| D003560 | Cysts |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D001519 | Behavior |
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