RecruitingOBSERVATIONAL

Vegetalization of the Maternal Diet During Pregnancy: Association With Pregnancy Outcomes and Newborn Health.

This research trial, called VEGALIM, is investigating how a pregnant woman's diet, particularly if it includes more plant-based foods, might influence her health and the health of her baby. Currently, we don't have much information on how eating more plants during pregnancy affects mothers and newborns. The study aims to understand the types of diets pregnant women follow, focusing on how much plant-based food they eat early and late in pregnancy. Researchers will also look at how their diet might affect certain fats in their blood, which could then impact their health during pregnancy and the baby's health. This is an important step to learn more about the best nutrition for expectant mothers and their little ones.

At a glance

Status

Recruiting

Sponsor

Nantes University Hospital

Enrolment target

670

Start

18 Mar 2024

Estimated completion

18 Dec 2027

Diet During Pregnancy

What is this study about?

This research study, known as VEGALIM, is designed to explore a really important topic: how what a pregnant woman eats affects her health and her baby's health. We know that eating more plant-based foods can be good for adults, but we don't have a lot of information about what this means for pregnant women and their babies.

The main goal of this study is to learn more about the types of diets pregnant women eat, specifically looking at how much plant-based food is included. Researchers will collect information about diets both early and later in pregnancy. They will also examine how these diets might affect certain measurements in the mother's blood, which could be important for her health during pregnancy and for the baby's development. This study aims to fill in some gaps in our knowledge and help us understand the potential benefits or impacts of plant-rich diets during this crucial time.

Ultimately, the findings from this study could help us better understand the links between a mother's diet, her own health during pregnancy, and the health of her newborn. This information can then help healthcare professionals provide better guidance on nutrition for pregnant women in the future, with the aim of promoting the best possible outcomes for both mother and child.

Key takeaways

Researchers want to understand how a mother's diet, especially plant-based foods, affects pregnancy and her baby's health.
The study involves answering questions about your diet and giving a small blood sample twice during pregnancy.
You won't be asked to change what you eat.
This study aims to gather important information that could help future pregnant women.
Participation will not affect your regular pregnancy care.
You can stop being part of the study at any time.

Who may be eligible?

To join this study, you need to be a pregnant woman who is already attending the CEMAFOER clinic at Nantes University Hospital for your pregnancy care. Your pregnancy should be between 11 weeks and 13 weeks and 6 days along. You also need to be able to understand and speak French.

There are some reasons why you might not be able to join. For example, if you are under 18 years old, you cannot participate. Also, if you prefer not to be part of the study for any reason, that's absolutely fine, and you won't be included. Finally, if you have any difficulties that would prevent you from understanding or answering questionnaires, you wouldn't be able to take part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you pregnant and attending CEMAFOER at Nantes University Hospital?
Is your pregnancy currently between 11 and 13 weeks and 6 days?
Are you 18 years old or older?
Can you understand and speak French?
Are you comfortable filling out questionnaires and having a blood test?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, the researchers will ask you to complete some questionnaires about the foods you eat. This helps them understand your diet. You will also have a small blood sample taken from you – about 4 millilitres, which is less than a teaspoon. These steps will likely happen twice during your pregnancy: once early on (around 11-13 weeks) and again later in your pregnancy. The study doesn't involve taking any new medications, and there won't be any extra follow-up appointments beyond your usual pregnancy care. The total duration of your participation would cover the period of your pregnancy during which these assessments are taken.

Potential risks and benefits

Taking part in this study means you'll be contributing valuable information that could help other pregnant women and their babies in the future, which is a potential benefit. As this is an observational study, it doesn't involve any new treatments, so there are no new medical risks from interventions. The blood draw is a very common procedure and carries minimal risk, such as slight bruising. You always have the right to withdraw from the study at any time without giving a reason, and this will not affect your medical care.

Locations (1)

CHU de Nantes
Verified postcode
Nantes, France· Recruiting

Common questions

What is 'vegetalization' of the diet?

It simply means eating more foods that come from plants, like fruits, vegetables, grains, and beans, and less food from animals.

Will I have to change my diet for this study?

No, this study only aims to understand what you already eat. You won't be asked to change your diet.

How much blood will be taken?

A very small amount, about 4 millilitres, which is less than a teaspoon.

Will my baby be affected by taking part?

No, the study doesn't involve any treatments or changes that would affect your baby. It's about observing your current diet.

What if I decide I don't want to be in the study anymore?

You can leave the study at any time without giving a reason, and your medical care will not be affected.

How to find out more

Norbert Winer, MD, PHD

norbert.winer@chu-nantes.fr +33 (0)2 40 08 78 00 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.