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| Name | Class |
|---|---|
| Advancing a Healthier Wisconsin Endowment | OTHER |
| Food for Health, Inc. | UNKNOWN |
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The goal of this study is to learn whether access to healthy and fresh food, health coaching, and nutrition support intervention can reduce adverse birth outcomes in pregnant women. The main questions it aims to answer are:
Participants in the standard of care will be asked to:
Participants in the intervention group will be asked to:
Researchers will compare the standard of care to those who receive the intervention to see the impact of the intervention on clinical outcomes including: gestational weight gain, blood pressure, diagnosis of gestational diabetes, diagnosis of gestational hypertension or preeclampsia, and gestational age at birth.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Prenatal Care | No Intervention | Standard Prenatal Care, biometric screenings, and surveys (baseline, 4-12 weeks postpartum). | |
| Maternal Health Management Program | Experimental | Program participants will receive 10 fresh, local meals each week, delivered to their homes, health coaching including cooking and physical activity, biometrics screenings, and educational support to enable sustainable lifestyle change. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Maternal Health Management Program | Behavioral | Program participants will receive 10 fresh, local meals each week, delivered to their homes, health coaching including cooking and physical activity, biometrics screenings, and educational support to enable sustainable lifestyle change. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Outcomes | gestational weight gain (BMI early pregnancy in comparison to BMI at delivery) | End of Pregnancy up to 8 weeks postpartum (+/- 2 weeks) |
| Clinical Outcomes | blood pressure (Compared to early pregnancy, intrapartum, postpartum | End of Pregnancy up to 8 weeks postpartum (+/- 2 weeks) |
| Clinical Outcomes | Diagnosis of gestational diabetes | End of Pregnancy up to 8 weeks postpartum (+/- 2 weeks) |
| Clinical Outcomes | Diagnosis of preeclampsia or gestational hypertension | End of Pregnancy up to 8 weeks postpartum (+/- 2 weeks) |
| Clinical Outcomes | Gestational age at birth (Weeks and Days) | End of Pregnancy up to 8 weeks postpartum (+/- 2 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Reported Outcomes | program utilization (measured by percentage of weekly coaching attended and number of meals consumed) | End of Pregnancy up to 8 weeks postpartum (+/- 2 weeks) |
| Patient Reported Outcomes |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anna Palatnik, MD | Medical College of Wisconsin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Froedert & The Medical College of Wiscosin | Milwaukee | Wisconsin | 53226 | United States |
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| ID | Term |
|---|---|
| D016640 | Diabetes, Gestational |
| D046110 | Hypertension, Pregnancy-Induced |
| D011225 | Pre-Eclampsia |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D003920 | Diabetes Mellitus |
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participant satisfaction and retention (measured by end of study evaluation)
| End of Pregnancy up to 8 weeks postpartum (+/- 2 weeks) |
| Patient Reported Outcomes | self-efficacy skills with meals preparation (as measured by nutrition survey) | End of Pregnancy up to 8 weeks postpartum (+/- 2 weeks) |
| Patient Reported Outcomes | physical activity planning (as measured by physical activity survey) | End of Pregnancy up to 8 weeks postpartum (+/- 2 weeks) |
| Patient Reported Outcomes | Self-Efficacy (as measure by Self-Efficacy survey) | End of Pregnancy up to 8 weeks postpartum (+/- 2 weeks) |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |