Food is Medicine for Gestational Diabetes

SS
Overseen ByShreela Sharma, PhD
Age: 18 - 65
Sex: Female
Trial Phase: Academic
Sponsor: The University of Texas Health Science Center, Houston
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a "Food is Medicine" approach can prevent gestational diabetes (a type of diabetes that develops during pregnancy) in at-risk women. It compares the effects of providing fresh produce prescriptions (Produce Rx) alongside standard medical care to standard care alone. Pregnant women receiving care at Harris Health clinics, on Medicaid, and with certain risk factors like a high BMI and family history of diabetes might be suitable participants. The study aims to determine if increased fruit and vegetable consumption can improve pregnancy health. As an unphased study, this trial offers a unique opportunity to contribute to innovative research that could enhance pregnancy health for many women.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are already prescribed insulin or metformin, you would not be eligible to participate.

What prior data suggests that the "Food is Medicine" intervention is safe for pregnant women?

Research has shown that Produce Rx programs are safe and well-tolerated. In studies where pregnant women received produce prescriptions, no major safety concerns emerged. These programs aim to improve diet by providing fresh fruits and vegetables. This method is generally considered safe because it uses food to manage health, rather than medication or invasive treatments.

The safety of Produce Rx is further supported by its use in addressing nutrition-related health issues without negative effects. This suggests it is a safe option for pregnant women, especially those at risk for gestational diabetes, as it aims to improve diet and health outcomes.12345

Why are researchers excited about this trial?

Researchers are excited about the Produce Rx treatment for gestational diabetes because it introduces a fresh approach by focusing on nutrition as medicine. Unlike standard treatments that typically involve dietary advice combined with insulin or oral medications like metformin, Produce Rx provides participants with fresh fruits and vegetables, aiming to control blood sugar levels naturally through a diet rich in whole foods. This treatment leverages the natural benefits of produce to potentially improve health outcomes without the side effects associated with traditional medications. By emphasizing food as a foundational element of care, this approach not only supports blood sugar management but may also enhance overall maternal and fetal health.

What evidence suggests that the "Food is Medicine" intervention might be an effective treatment for gestational diabetes?

Research has shown that providing pregnant women with vouchers for fresh fruits and vegetables can improve their health. These "produce prescriptions" may help control weight gain during pregnancy and lower the risk of issues like gestational diabetes, which affects blood sugar levels. In this trial, participants in the "Food is Medicine (FIM) Intervention plus Standard of Care" arm will receive these vouchers as part of the intervention. Pregnant women who struggle to afford enough food often experience higher rates of this condition, but these vouchers can help them eat better. The "Food is Medicine" approach uses diet to enhance health for both mothers and babies. This method could lead to healthier pregnancies and reduce the chances of gestational diabetes for those at risk.12345

Who Is on the Research Team?

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Shreela Sharma, PhD

Principal Investigator

The University of Texas Health Science Center, Houston

Are You a Good Fit for This Trial?

This trial is for pregnant women at high risk of developing gestational diabetes who are receiving care within the Harris Health system. Specific eligibility criteria have not been provided, but typically participants would need to meet certain health and pregnancy-related standards.

Inclusion Criteria

Fall within the study delivery radius
Pregnant women receiving care at Harris Health clinics
I am eligible for or currently receive Medicaid.
See 2 more

Exclusion Criteria

Have hemoglobin A1c>=7
I have type 2 diabetes that existed before pregnancy.
I am currently taking insulin or metformin.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the 'Food is Medicine' (FIM) intervention to assess its effectiveness on gestational diabetes mellitus

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Produce Rx
Trial Overview The study is testing a 'Food is Medicine' (FIM) intervention against the standard of care to see if it can reduce the incidence of gestational diabetes in at-risk pregnant women.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Food is Medicine (FIM) Intervention plus Standard of CareExperimental Treatment2 Interventions
Group II: Standard of CareActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

The University of Texas Health Science Center, Houston

Lead Sponsor

Trials
974
Recruited
361,000+

Citations

Healthy Baby, Healthy Mom Produce Rx TrialProduce prescriptions hold significant promise for addressing the alarming crisis of nutrition-related adverse outcomes and disparities for pregnant women.
Fresh funds for moms: feasibility of a 12-week online food as ...Pregnant women with food insecurity experience high rates of gestational diabetes mellitus (GDM). Food as medicine and grocery prescription (GPx) ...
Produce Prescription: Improving diet and health outcomes ...Our study aims to test whether a 'Produce Prescription' intervention can reduce gestational weight gain and prevent pregnancy complications ...
Center for Health Equity Launches Produce Rx Program to ...The program will follow pregnancy and post-partum in a 24-month period, collecting data through electronic medical records for clinical outcomes ...
Produce Rx in High Risk Pregnant Mothers at Harris HealthThe purpose of this study is to assess the effectiveness of a "Food is Medicine" (FIM) intervention on incidence of gestational diabetes ...
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