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The purpose of this study is to assess the effectiveness of a "Food is Medicine" (FIM) intervention on incidence of gestational diabetes mellitus (GDM) among pregnant women at risk for GDM within the Harris Health system.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Food is Medicine (FIM) Intervention plus Standard of Care | Experimental |
| |
| Standard of Care | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Food is Medicine (FIM) Intervention | Behavioral | Intensive intervention phase - this phase starts at enrollment (<=14 weeks) through 28 weeks of gestation (or at the time of GDM diagnostic test) and women i) receive a bi-weekly home delivery of a "mixed box" consisting of fresh produce, lean protein, and whole grains combined with culinary medicine-based nutrition education available in English and Spanish. Maintenance phase - this phase starts at 29 weeks through 12 weeks postpartum, and women will receive biweekly deliveries of about 10-15 pounds of fresh produce (8-10 different kinds of produce) plus standard nutrition education. The box will be curated for prenatal nutrients needs and following American Diabetes Association guidelines. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with gestational diabetes mellitus (GDM) | 24-28 weeks gestational age (about 10-12 weeks after start of the intervention) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with hypertensive disorders of pregnancy | 24-28 weeks gestational age (about 10 weeks after start of the intervention) | |
| Number of infants with macrosomia at birth | at the time of birth |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shreela Sharma, PhD | Contact | (713) 500-9344 | Shreela.V.Sharma@uth.tmc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Shreela Sharma, PhD | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Health Science Center at Houston | Houston | Texas | 77006 | United States |
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| ID | Term |
|---|---|
| D016640 | Diabetes, Gestational |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D003920 | Diabetes Mellitus |
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| ID | Term |
|---|---|
| D008722 | Methods |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
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|
| Standard of Care | Behavioral | Standard medical care provided at Harris Health for high-risk pregnant women, plus a voucher equal to the value of the produce and meals provided in the Food is Medicine (FIM) Intervention. |
|
| Number of infants with pre-term birth | at the time of birth |
| Number of infants born via C-section | at the time of birth |
| Change in Hemoglobin A1c levels | at the time of the first prenatal visit, at the time of birth |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D017530 | Health Care Quality, Access, and Evaluation |