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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether access to healthy meals and health coaching can improve pregnancy outcomes, such as reducing the risks of gestational diabetes and preeclampsia. Participants will receive either standard prenatal care or additional benefits like fresh meals and coaching through the Maternal Health Management Program. The trial seeks pregnant individuals in Milwaukee County who are at risk for these conditions and meet specific criteria, such as a history of gestational diabetes or a higher pre-pregnancy weight. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance maternal health care.

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 prior data suggests that this dietary intervention is safe for pregnant women?

Research has shown that nutrition counseling during pregnancy is safe and can improve health. Pregnant women who receive this counseling often adopt healthier eating habits and make better lifestyle choices.

One study found that prenatal nutrition support, such as providing healthy meals and advice, helped reduce pregnancy complications. Most women managed these programs without major issues. Additionally, taking routine prenatal supplements like iron and folate reduced anemia and improved birth outcomes, supporting the safety of nutrition-focused programs.

Overall, evidence suggests that the Maternal Health Management Program, which includes meal deliveries and health coaching, is likely a safe option for pregnant women. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Maternal Health Management Program because it offers a comprehensive approach to improving maternal health through personalized, sustainable lifestyle changes. Unlike standard prenatal care, which typically focuses on medical monitoring and guidance, this program delivers fresh, local meals to expectant mothers, coupled with health coaching that includes cooking and physical activity. Additionally, it provides biometric screenings and educational support to empower lasting change, potentially reducing pregnancy complications more effectively than current methods.

What evidence suggests that the Maternal Health Management Program is effective for preventing pregnancy complications?

Research has shown that nutrition counseling and support can improve the health of pregnant women and their babies. In this trial, participants in the Maternal Health Management Program will receive nutrition advice and support, which studies have found can decrease pregnancy complications like gestational diabetes and preeclampsia (a condition with high blood pressure). One study found that a detailed dietary plan led to better eating habits and health during pregnancy. Another study supported the idea that good nutrition during pregnancy can reduce the risk of early births and other health problems. Overall, these findings suggest that programs offering healthy meals and guidance, like the Maternal Health Management Program in this trial, can greatly benefit the health of mothers and their babies. ^{1 4 6 7 8}

Who Is on the Research Team?

Anna Palatnik, MD

Principal Investigator

Medical College of Wisconsin

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10687348/

Effectiveness of nutrition counseling for pregnant women in low Nutrition counseling is anticipated to improve maternal and infant health outcomes thereby contributing to reduced risk of mortality, pregnancy ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10660825/

Dietitian-led cluster randomised controlled trial on the ... This study aimed to address the gap between current knowledge and clinical care, by exploring the effectiveness of mHealth on GWG as the primary outcome.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT02745249

Assessing the Feasibility of Integrating Maternal Nutrition ... Inadequate maternal nutrition is likely to undermine the potential impact of infant and young child feeding (IYCF) improvements made in the Alive & Thrive ...

4. mdpi.com mdpi.com/2072-6643/16/2/217

Effects of a Comprehensive Dietary Intervention Program ... Intra-group comparison results show that pregnant women receiving CDIP intervention demonstrated a significant improvement in total eating ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0022316622159183

Nutritional Interventions during Pregnancy for the ... This overview assesses the effectiveness of nutritional interventions to prevent or treat maternal morbidity, mortality and preterm delivery.

6. odphp.health.gov odphp.health.gov/healthypeople/objectives-and-data/browse-objectives/pregnancy-and-childbirth

Pregnancy and Childbirth - Healthy People 2030 Healthy People 2030 focuses on preventing pregnancy complications and maternal deaths and helping women stay healthy before, during, and after pregnancy.

7. who.int who.int/health-topics/maternal-health

Maternal health Maternal health refers to the health of women during pregnancy, childbirth and the postnatal period. Each stage should be a positive experience.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9612182/

Focusing on Maternal Nutrition to Improve the Health and ... Studies have shown that routine prenatal iron-folate supplementation is effective in reducing anemia and improving birth outcomes.