Dietary Intervention for Preventing Pregnancy Complications

(PLATE Trial)

Overseen By Amandla Stanley, MSN

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Medical College of Wisconsin

Must not be taking: Psychotropics, Corticosteroids

Disqualifiers: Diabetes, Renal disease, Bowel disease, others

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

Compensation: Varies

Number of Visits: 2

Duration: Duration of pregnancy

100 Participants Needed

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.

My BMI was 25 or higher before I got pregnant.

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

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).

Who Is Running the Clinical Trial?

Medical College of Wisconsin

Lead Sponsor

Trials

645

Recruited

1,180,000+

Food for Health, Inc.

Collaborator

Trials

1

Recruited

100+

Advancing a Healthier Wisconsin Endowment

Collaborator

Trials

2

Recruited

150+

Findings from Research

Improving maternal nutrition before, during, and after pregnancy is crucial for better pregnancy outcomes, highlighting the importance of primary prevention strategies.

Nutritional care can benefit all women, including those not planning to become pregnant, by promoting healthier behaviors that enhance overall health and prepare them for potential future pregnancies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutrition during pregnancy and lactation. Abrams, BF., Berman, CA.[2008]

Adequate nutrition during the periconceptional and prenatal periods is crucial for reducing the risk of pregnancy complications and improving birth outcomes, highlighting the importance of maternal nutritional status.

Evidence-based tools and recommendations can help healthcare providers assess and optimize the diets of pregnant women, ultimately supporting healthier pregnancies and reducing the risk of chronic diseases in their children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prenatal nutrition: a practical guide for assessment and counseling. Widen, E., Siega-Riz, AM.[2021]

Calcium supplementation during pregnancy significantly reduces the risk of high blood pressure and pre-eclampsia in women at high risk or with low dietary calcium intake, with relative risks of 0.35 and 0.22 respectively, based on systematic reviews of multiple trials.

Routine iron and folate supplementation is recommended for pregnant women in areas with high rates of nutritional anemia, as it effectively increases pre-delivery hemoglobin levels, although the benefits of these supplements in well-nourished populations remain unclear.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutritional interventions for the prevention of maternal morbidity. Kulier, R., de Onis, M., Gülmezoglu, AM., et al.[2019]

A review of randomized controlled trials found that dietary and lifestyle interventions during pregnancy for overweight or obese women did not show significant benefits compared to standard care for maternal or infant health outcomes.

Only two trials were identified, indicating a lack of sufficient research on the effectiveness and safety of these interventions, highlighting the need for more robust studies in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary and lifestyle interventions to limit weight gain during pregnancy for obese or overweight women: a systematic review. Dodd, JM., Crowther, CA., Robinson, JS.[2022]

Maternal nutrition significantly influences fetal and neonatal outcomes, highlighting the importance of a balanced diet during pregnancy.

The typical American diet often lacks sufficient fruits, vegetables, and whole grains while being high in sodium, fats, and carbohydrates, which can negatively affect pregnancy outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Maternal Nutrition and Fetal/Infant Development. Jain, S., Maheshwari, A., Jain, SK.[2022]

A study involving 388 pregnant women along the Myanmar-Thailand border revealed that many had limited knowledge of healthy dietary practices, which could lead to poor pregnancy outcomes.

The research highlights the need for culturally appropriate nutrition education to improve awareness and health outcomes in marginalized communities, suggesting that tailored interventions could significantly benefit maternal nutrition.

NCBI (Pubmed)

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. Hashmi, AH., Paw, MK., Nosten, S., et al.[2021]

In a study of 276 pregnant women, those who received individualized nutritional management gained significantly less weight during pregnancy (7.58 kg) compared to those who only received routine care (12.57 kg), indicating the effectiveness of nutritional intervention in managing weight gain.

The intervention group also experienced lower rates of pregnancy complications, with only 3.1% developing preeclampsia and 3.8% gestational diabetes, compared to 11% and 14.5% in the control group, respectively, suggesting that nutritional management can improve maternal health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of nutritional management intervention on gestational weight gain and perinatal outcome. Luo, XD., Dong, X., Zhou, J.[2021]

Maternal undernutrition significantly affects pregnancy outcomes, with preconception nutrition interventions showing promise in improving birth size and reducing risks of low birth weight and small for gestational age births.

Evidence-based strategies during pregnancy, such as protein and micronutrient supplements, can enhance birth outcomes, but more research is needed to address implementation and equity in maternal nutrition programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Maternal Undernutrition before and during Pregnancy and Offspring Health and Development. Young, MF., Ramakrishnan, U.[2021]

Antenatal lifestyle interventions for pregnant women with overweight or obesity significantly improved dietary patterns, with higher 'prudent' diet scores and lower 'Western' diet scores compared to standard care, indicating better nutritional choices during and after pregnancy.

The effectiveness of the intervention varied based on initial BMI and smoking status, suggesting that personalized approaches may enhance dietary improvements for different groups of women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of a lifestyle intervention on pregnancy and postpartum dietary patterns determined by factor analysis. Moran, LJ., Flynn, AC., Louise, J., et al.[2018]

References

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

Nutrition during pregnancy and lactation. [2008]

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

Prenatal nutrition: a practical guide for assessment and counseling. [2021]

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

Nutritional interventions for the prevention of maternal morbidity. [2019]

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]

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

Maternal Nutrition and Fetal/Infant Development. [2022]

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]

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

Effects of nutritional management intervention on gestational weight gain and perinatal outcome. [2021]

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

Maternal Undernutrition before and during Pregnancy and Offspring Health and Development. [2021]

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]