Dietary Intervention for Preventing Pregnancy Complications

(PLATE Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Anna Palatnik, MD

Age: 18 - 65

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Medical College of Wisconsin

Must not be taking: Psychotropics, Corticosteroids

Disqualifiers: Diabetes, Renal disease, Bowel disease, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

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: * Does access to healthy and fresh food, health coaching and nutrition support reduce the risk of gestational diabetes or preeclampsia and ultimately improve health outcomes for mothers and their newborns? * Are participants able to successfully utilize the health program? Are participants satisfied and self-equipped to apply the teachings of the program within their lives following their participation in the study? Participants will be randomly assigned to one of two groups. Participants in the standard of care will be asked to: * Complete surveys * Biometric screenings Participants in the intervention group will be asked to: * Complete surveys * Biometric screenings * Participate in weekly personal health coaching * Receive and consume provided weekly meals. 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.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you are using weight-increasing psychotropic agents or chronic oral corticosteroids, you may not be eligible to participate.

What data supports the effectiveness of the treatment Maternal Health Management Program, Maternal Nutrition Intervention, Pregnancy Nutrition Support, Healthy Eating Program for Pregnant Women in preventing pregnancy complications?

Research shows that good nutrition during pregnancy can lower the risk of complications and improve outcomes for both mother and baby. Studies highlight that improving maternal nutrition before and during pregnancy is a key way to prevent health issues and promote healthy development. ^{1 2 3 4 5}

Is the dietary intervention for preventing pregnancy complications safe for humans?

Research shows that nutritional interventions during pregnancy, such as balanced-energy protein supplements and micronutrient supplements, are generally safe and can improve birth outcomes. These interventions are designed to support maternal health and reduce the risk of pregnancy complications. ^{2 3 6 7 8}

How is the Maternal Health Management Program different from other treatments for preventing pregnancy complications?

The Maternal Health Management Program is unique because it focuses on improving maternal nutrition through a structured dietary intervention, which is designed to optimize the mother's nutritional status and prevent pregnancy complications. Unlike other treatments that may focus on medication or general lifestyle changes, this program specifically targets dietary habits to achieve healthier pregnancy outcomes. ^{2 3 4 7 9}

Research Team

Anna Palatnik, MD

Principal Investigator

Medical College of Wisconsin

Eligibility Criteria

This trial is for pregnant women over 18, with a BMI ≥ 25 kg/m^2, living in Milwaukee County on Medicaid. They must be less than 17 weeks pregnant, at risk of preeclampsia or gestational diabetes, have internet access and speak English.

Inclusion Criteria

I am getting prenatal care at Froedtert.

I am at risk for preeclampsia or gestational diabetes due to my medical history or conditions.

I am 18 years old or older.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive weekly personal health coaching and provided meals, along with completing surveys and biometric screenings

Duration of pregnancy

Weekly visits (in-person or virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including surveys and biometric screenings

8 weeks postpartum (+/- 2 weeks)

2-3 visits (in-person)

Treatment Details

Interventions

• Maternal Health Management Program (Behavioral Intervention)

Trial Overview The study tests if a Maternal Health Management Program with health coaching and weekly meals can lower the risk of gestational diabetes or preeclampsia compared to standard care. Outcomes like weight gain and blood pressure are measured.

Participant Groups

Group I: Maternal Health Management Program Experimental Treatment 1 Intervention

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.

Group II: Standard Prenatal Care Active Control 1 Intervention

Standard Prenatal Care, biometric screenings, and surveys (baseline, 4-12 weeks postpartum).

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Froedert & The Medical College of Wiscosin Milwaukee, WI

Who Is Running the Clinical Trial?

Medical College of Wisconsin

Lead Sponsor

Trials

645

Patients Recruited

1,180,000+

Food for Health, Inc.

Collaborator

Trials

1

Patients Recruited

100+

Advancing a Healthier Wisconsin Endowment

Collaborator

Trials

2

Patients Recruited

150+

References

1. United States pubmed.ncbi.nlm.nih.gov

Nutrition during pregnancy and lactation. [2008] Because appropriate maternal nutrition improves pregnancy outcome, improving maternal nutrition before, during, and after pregnancy is an excellent example of primary prevention. Providing assessment and intervention to encourage an optimal state of health will also benefit the many women who do not desire pregnancy. For these women, the provision of nutritional care as part of a periodic health assessment can serve not only as a way to enhance health status in preparation for a future pregnancy, but also as a mechanism for encouraging nutritional behaviors to improve health throughout life.

2. United States pubmed.ncbi.nlm.nih.gov

Prenatal nutrition: a practical guide for assessment and counseling. [2021] Adequate nutrition during the periconceptional and prenatal periods is important for healthy pregnancy outcomes. By enhancing maternal nutritional status, health care providers can help pregnant women lower their risk of certain pregnancy complications and decrease their children's risk of adverse birth outcomes and later chronic disease. Use of evidence-based tools and recommendations will assist in the assessment of pregnant women's diets and streamline the counseling session to optimize their nutritional status. This article contains a review of the literature related to nutrition intervention studies during pregnancy that were designed to improve habits or achieve target weight gains and nutrition recommendations specific for the pregnancy state, as well as tools/resources for the health care provider for implementation of these recommendations into their busy practices.

3. United States pubmed.ncbi.nlm.nih.gov

Nutritional interventions for the prevention of maternal morbidity. [2019] To review the effectiveness of nutritional interventions to prevent maternal morbidity.

4. United States pubmed.ncbi.nlm.nih.gov

Dietary and lifestyle interventions to limit weight gain during pregnancy for obese or overweight women: a systematic review. [2022] To assess the benefits and harm of dietary and lifestyle interventions during pregnancy to improve maternal and infant outcomes for pregnant women who are overweight or obese.

5. United States pubmed.ncbi.nlm.nih.gov

Maternal Nutrition and Fetal/Infant Development. [2022] Nutrition in pregnant mothers has long been known to be an important determinant of fetal/maternal outcomes. In general, the typical American diet shows opportunities for improvement. The intake of fruits, vegetables, whole grains, and fiber may be below recommended levels, but the relative proportion of sodium, fats, and carbohydrates seems high. In this review, we present current evidence on how the fetal/neonatal outcomes may be altered by maternal nutrition at the time of conception, fetal nutrition in utero, contribution of maternal dietary factors in fetal outcomes, weight gain during pregnancy, diabetes during pregnancy, fetal growth restriction (FGR), maternal nutritional status during later pregnancy, and pregnancy in adolescent mothers.

6. United States pubmed.ncbi.nlm.nih.gov

'Because the baby asks for it': a mixed-methods study on local perceptions toward nutrition during pregnancy among marginalised migrant women along the Myanmar-Thailand border. [2021] Under- and over-nutrition during pregnancy are known risk factors for pregnancy complications and adverse pregnancy and infant outcomes. Understanding perceptions around nutrition in pregnancy can create culturally appropriate interventions for improved health outcomes.

7. Saudi Arabia pubmed.ncbi.nlm.nih.gov

Effects of nutritional management intervention on gestational weight gain and perinatal outcome. [2021] To evaluate whether nutritional management intervention can prevent excessive weight gain during pregnancy and improve perinatal outcomes.

8. Switzerland pubmed.ncbi.nlm.nih.gov

Maternal Undernutrition before and during Pregnancy and Offspring Health and Development. [2021] Maternal undernutrition remains a critical public health problem. There are large regional and within-country disparities in the burden of underweight, anemia, and micronutrient deficiencies across the globe. Driving these disparities are complex and multifactorial causes, including access to health services, water and sanitation, women's status, and food insecurity as well as the underlying social, economic, and political context. Women's health, nutrition, and wellbeing across the continuum of preconception to pregnancy are critical for ensuring positive pregnancy and long-term outcomes for both the mother and child. In this review, we summarize the evidence base for nutrition interventions before and during pregnancy that will help guide programs targeted towards women's nutrition. Growing evidence from preconception nutrition trials demonstrates an impact on offspring size at birth. Preconception anemia and low preconception weight are associated with an increased risk of low birth weight and small for gestational age births. During pregnancy, several evidence-based strategies exist, including balanced-energy protein supplements, multiple micronutrient supplements, and small-quantity lipid nutrient supplements for improving birth outcomes. There, however, remain several important priority areas and research gaps for improving women's nutrition before and during pregnancy. Further progress is needed to prioritize preconception nutrition and access to health and family planning resources. Additional research is required to understand the long-term effects of preconception and pregnancy interventions particularly on offspring development. Furthermore, while there is a strong evidence base for maternal nutrition interventions, the next frontier requires a greater focus on implementation science and equity to decrease global maternal undernutrition disparities.

9. United States pubmed.ncbi.nlm.nih.gov

The effect of a lifestyle intervention on pregnancy and postpartum dietary patterns determined by factor analysis. [2018] Optimizing maternal diet during pregnancy improves maternal and infant health. This study assessed the effect of an antenatal lifestyle intervention for women with overweight or obesity on dietary patterns during pregnancy and post partum.