Food is Medicine for Gestational Diabetes
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.12345Why 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?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive the 'Food is Medicine' (FIM) intervention to assess its effectiveness on gestational diabetes mellitus
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Produce Rx
Find a Clinic Near You
Who Is Running the Clinical Trial?
The University of Texas Health Science Center, Houston
Lead Sponsor