Clinical trial NCT06155344: Vegetalization of the Maternal Diet During Pregnancy: Association With Pregnancy Outcomes and Newborn Health.
Official title: VEGALIM : Vegetalization of the Maternal Diet During Pregnancy: Association With Pregnancy Outcomes and Newborn Health.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Diet During Pregnancy
Keywords: Pregnancy
Newborn
Vegetalization
Food
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
Collaborators: name: UMR 1280 PHAN
name: INRAE - CRESS
First posted: 2023-12-04
Enrollment: 670
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be included during the 1st trimester follow-up visit (at 11-13 amenorrhea weeks (AW) + 6 days), organized by the maternal and fetal pathology screening and risk assessment center (CEMAFOER) at the Nantes University Hospital. Patients will then be informed of the research project, and their written consent to participate in the study will be obtained.

Brief summary: Reducing consumption of foods of animal origin in favor of more plant-based diets is a major environmental, public health and economic challenge. Data on the health effects of highly vegetalized diets are available only in adults. Few studies report the effect of the level of vegetalization of the maternal diet during pregnancy on the mother's health, and the development and health of the child. The VEGALIM project aims to describe the level of vegetalization of pregnant women's diets and the nutritional quality of their diets early in pregnancy (first trimester) and late pregnancy, and to explore the potential effects on their plasma lipid profile that may impact on their health during pregnancy and the health of the newborn.


Eligibility criteria: Inclusion Criteria :

* Pregnant women consulting the CEMAFOER at the Nantes University Hospital for pregnancy monitoring
* Gestational age between 11 and 13 AW +6 days
* Understanding French

Exclusion Criteria:

* Patients under 18 years of age
* Patient who objected to being included in the study
* Patient with cognitive problems that prevent her from answering questionnaires

Primary outcomes:
measure: Characterizing the levels of plant-based food consumption at the beginning of pregnancy (at the end of the first trimester of pregnancy) based on the completion of the Food Frequency Questionnaire (FFQ, scale from 0 to 6 ; 0 being the worst outcome)
timeFrame: 25 minutes
Secondary outcomes:
measure: Study the evolution of the vegetation score between the 1st and 3rd trimester of pregnancy
timeFrame: 6 months
measure: Study changes in diet quality between the 1st and 3rd trimesters of pregnancy
timeFrame: 6 months
measure: Studying the association between vegetarian diets in the first trimester of pregnancy and pregnancy outcomes (such as prematurity, birth weight, maternal pathologies not present at the time of inclusion (gestational diabetes, pre-eclampsia, etc.).
timeFrame: 6 months
measure: Study the association between diet quality in the first trimester of pregnancy and pregnancy outcomes (such as prematurity, birth weight, maternal pathologies not present at the time of inclusion (gestational diabetes, pre-eclampsia, etc.).
timeFrame: 6 months
measure: Study the association between the vegetalization of the diet and the lipid profile of women in the 1st trimester and at childbirth.
timeFrame: 6 months
measure: Study the association between diet quality and lipid profiles of women in the 1st trimester and at childbirth.
timeFrame: 6 months
measure: Study the association between the vegetalization of the diet and the total fatty acid status of women in the 1st trimester and at childbirth.
timeFrame: 6 months
measure: Study the association between diet quality and total fatty acid status in women at 1st trimester and at childbirth.
timeFrame: 6 months
measure: Identify other biological markers, such as vitamins, that may be impacted by a change in diet, and study the influence of diet quality on these potential plasma markers.
timeFrame: 6 months
Other outcomes:
Locations:
city: Nantes
country: France
facility: CHU de Nantes
state: Loire-Atlantique
Study officials:
affiliation: Nantes University Hospital
name: Norbert Winer, MD, PHD
role: PRINCIPAL_INVESTIGATOR
affiliation: UMR 1280 PHAN
name: Veronique Ferchaud-Roucher, PhD
role: STUDY_DIRECTOR
References: