Food Rx Program for Nutrition in Pregnancy

Overseen By Naomi Tice, MPH

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: The University of Texas Health Science Center, Houston

Disqualifiers: Not high-risk, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 9 months

620 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a program providing pregnant women with fresh fruits and vegetables, along with nutrition education, can improve pregnancy and birth outcomes. The program, Fresh Connect Food Rx, targets women in Houston considered high-risk due to being overweight, having diabetes or hypertension, or having experienced these conditions in previous pregnancies. Participants will begin the program at their first prenatal visit and continue until about two months postpartum. The goal is to determine if better access to nutritious food can positively impact the health of both mother and baby and improve food security. As an unphased trial, this study offers a unique opportunity to contribute to important research that could enhance maternal and infant health.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that the Fresh Connect Food Rx program is safe for pregnant women?

Research shows that the Fresh Connect Food Rx program aims to improve food security and reduce stress, depression, and anxiety in pregnant women. This program uses a "food is medicine" approach by providing fresh produce and nutrition education.

Past studies reported no negative side effects or safety issues with the program. The main focus is on making healthy food more accessible, which presents a low-risk approach. Participants experienced better food security and mental health, indicating that the program is well-tolerated and safe during pregnancy.

In summary, the Fresh Connect Food Rx program appears to be a safe choice for expecting mothers, with no known negative effects reported in the reviewed studies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Food Rx Program for Nutrition in Pregnancy because it introduces a fresh approach to supporting maternal health. Unlike traditional prenatal care that often focuses on supplements and dietary advice, this program uses the Fresh Connect Food Rx, which provides direct access to healthy, fresh foods. The program emphasizes enhanced engagement communication, tailored to motivate and guide pregnant individuals more effectively in making nutritious food choices. This direct access and personalized support have the potential to improve pregnancy outcomes by addressing nutritional needs in a more interactive and supportive manner.

What evidence suggests that the Fresh Connect Food Rx program could be effective for improving pregnancy and birth outcomes?

Research shows that the Fresh Connect Food Rx program, available to participants in this trial, can improve pregnancy and birth outcomes by reducing food insecurity and stress. Studies have found that such programs lower the risk of early labor and low birth weight. Participants in similar programs reported better access to fresh fruits and vegetables, often leading to healthier pregnancies. One study found that individuals using these food benefits shopped monthly for healthy foods. This approach not only improves food access but also supports the health of both mothers and babies during pregnancy. ^{1 2 4 6 7}

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 low-income, ethnically diverse pregnant women in Houston, Texas. They must be at high risk and enroll during their first prenatal visit if it's before the end of the first trimester. Participants will be followed until 60 days after giving birth.

Inclusion Criteria

High-risk pregnant mothers receiving care at Texas Children's Health Plan (TCHP) managed care organizations in Houston, Texas

Pregnancy less than 20 weeks gestation confirmed medically viable

I was overweight before or during early pregnancy, and/or have had diabetes or high blood pressure.

Exclusion Criteria

Not a high-risk pregnant mother receiving care at Texas Children's Health Plan (TCHP) managed care organizations in Houston, Texas

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Fresh Connect food prescription program and nutrition education during pregnancy

Up to 9 months

Follow-up

Participants are monitored for gestational weight gain, pregnancy and birth outcomes, and food and nutrition security until 60 days post-partum

2 months

What Are the Treatments Tested in This Trial?

Interventions

• Fresh Connect Food Rx

Trial Overview The study tests whether a program called Fresh Connect Food Rx—offering access to fresh produce plus nutrition education—affects weight gain during pregnancy, birth outcomes, and food security among participants.

How Is the Trial Designed?

Group I: Usual care Fresh Connect cardholder engagement plus Enhanced engagement communication Experimental Treatment 2 Interventions

Group II: Usual care Fresh Connect cardholder engagement Active Control 1 Intervention

Who Is Running the Clinical Trial?

The University of Texas Health Science Center, Houston

Lead Sponsor

Trials

974

Recruited

361,000+

American Heart Association

Collaborator

Trials

352

Recruited

6,196,000+

Michael and Susan Dell Foundation

Collaborator

Tufts University

Collaborator

Trials

271

Recruited

595,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11568643/

Improving Maternal Health and Birth Outcomes Through ... This study examines a food-is-medicine approach that aimed to reduce food insecurity, maternal stress, depression, anxiety, preterm labor, and low birthweight.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38670549/

Improving Maternal Health and Birth Outcomes Through ... At baseline, 67.0% reported very low food security and none reported high food security, while 34.7% indicated depressive symptoms. Intervention: FreshRx ...

3. journals.sagepub.com journals.sagepub.com/doi/10.1177/22799036221102496

Does a food insecurity intervention improve perinatal ... The Fresh Rx: Nourishing Healthy Starts study uses a randomized design to examine a comprehensive, holistic “food is medicine” program targeting food insecure ...

4. ajcn.nutrition.org ajcn.nutrition.org/article/S0002-9165(24)00881-5/pdf

Produce prescription benefits redemption and activity in an ... This study found that participants with more store access had 14.5% higher redemption rates and 5-fold greater likelihood of monthly shopping. ...

5. jandonline.org jandonline.org/article/S2212-2672(24)00082-0/fulltext

Implementation and Impact of Perinatal Food Is Medicine ... Nutrition insecurity during this time can lead to poor maternal outcomes, including gestational diabetes; anemia; and preeclampsia (ie, pregnancy-induced high ...

6. ctv.veeva.com ctv.veeva.com/study/accelerating-healthcare-engagement-in-healthy-food-interventions-food-rx-in-high-risk-pregnant-mot

Food Rx in High Risk Pregnant Mothers With About Fresh and ... The purpose of the study is to assess if the Fresh Connect food prescription (Fresh Connect Food Rx) program that provides consistent access ...

7. portal.nifa.usda.gov portal.nifa.usda.gov/web/crisprojectpages/1029315-enhancement-of-award-number-2021-70030-35871-fidelity-equity-and-dignity-in-produce-prescriptions-participatory-design-for-social-justice-and-healthy-food-systems.html

Fidelity, Equity, and Dignity in Produce Prescriptions ... Redemption data from the Fresh Connect systems will supply monthly amounts spent for each participant and will be used to create metrics of redemption rate ...