Clinical trial NCT06669819: Influencing a Vegan Diet and the Intake of Dietary Supplements During Pregnancy and Childhood
Official title: Can Dietary Supplements be Linked to a Vegan Diet and Health Risk Modulation During Vegan Pregnancy, Infancy and Early Childhood
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Vegan Diet
Pregnancy
Dietary Supplements
Childhood
Keywords: vegan
pregnancy
pregnant
childhood
dietary supplements
parents
medical experts
paediatrician
gynaecologist
general practitioner
pharmacist
dietician
Lead sponsor: University of Vienna
Sponsor class: OTHER
Collaborators: name: University of Vienna
name: Austrian Agency for Health and Food Safety GmbH - AGES
First posted: 2024-11-01
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Planned sample size for surveyed vegans: About 0.5-1% of the Austrian population follows a vegan diet (estimated - currently no exact numbers exist - source: vegan society Austria). In 2022, 82,198 children were born in Austria (Statistik Austria). In 5 years, around 400,000 children will be born in Austria - if 0.5-1% of them have parents that follow a vegan diet and are therefore also fed vegan, this results in an estimated number of 2000-4000 children and vegan parents. 25% of these should be reached with the survey. This corresponds to a planned sample size of 500-1000 vegans. Planned sample size for surveyed medical experts: Based on other scientific surveys in which physicians were included, we aim for 50-60 participants per expert group (paediatricians, gynaecologists, general practitioners, pharmacists, dieticians) for the questionnaire (see references: Vilette et al, 2022; Bardheci et al, 2021; Hamiel et al, 2020).

Brief summary: The main goals of the exploratory, cross-sectional survey among vegans are to reveal influencing factors, sources of information gathering, reasons for choosing certain dietary supplements of pregnant vegans and parents, difficulties in administering dietary supplements to children, and the compliance of dietary supplements of vegans, because there is no data available yet. Results serve as a starting point for comprehensive information provision for surveyed vegans and provide insight into the nutritional knowledge of vegans. The advisory role of the medical experts is essential to provide vegans with reliable information on a balanced vegan diet and dietary supplements. The opinion of medical experts has a decisive influence on the health of vegans. For this reason the content of their advice will be assessed.

The main questions the study aims to answer are: Do vegan pregnant women and parents know about possible nutrient deficiencies during pregnancy and childhood and who do they turn to for information about nutritional supplements? What is the quality of the information received?

Detailed description: During intensive development phases, such as pregnancy and childhood, the probability of insufficient nutrient supply raises. In the course of a vegan diet, the focus should be on an adequate supply of vitamin B12, zinc, iron, calcium, vitamin D, iodide, omega-3 fatty acids and iron. Nutrient deficiency can be prevented by supplying these critical nutrients of a vegan diet adequately. A purely plant-based diet can provide all necessary macro- and micronutrients during pregnancy and childhood, except DHA and EPA, as well as vitamin B12. Newborns of vegan mothers are smaller (small for gestational age) and are born with a lower birth weight than those born from omnivores, which can lead to further nutrient-deficiency-related development and health consequences. If the mother lacks an adequate supply of nutrients, nutrient deficiencies can occur in the infant despite breastfeeding. Expert groups such as the Academy of Nutrition and Dietetics (AND) and German Society for Nutrition (DGE) disagree about the risks of a purely plant-based diet for pregnant women, infants and children. In the past no distinct statements were made on the benefits or drawbacks for vegan pregnant women and their children in terms of nutrient supply, due to a lack of well-designed studies. Latest findings show that there are risks of malnutrition, which can be prevented by dietary supplements and observing the health and developmental status of mother and child. Although the selection of vegan foods is becoming more diverse, there is no data on whether this expansion of the offer results in a better nutrient supply for vegans - the current state of studies suggests dietary supplementation is necessary. Pregnant women who consume an omnivorous diet are often taking dietary supplements to support the healthy development of their unborn children. Influencing factors that affect the approach of vegan pregnant women and parents towards dietary supplements have not yet been scientifically determined. It has been shown that mothers who feed their children a vegan diet have less nutritional knowledge than mothers whose children follow an ovo-lacto-vegetarian diet. Parents often ask pediatricians how to provide the most balanced diet for their children. For this reason, constructive communication between parents of vegan children and their pediatricians and dieticians is important in order to provide comprehensive information about a healthy, purely plant-based diet. The relationship between vegan parents and doctors can therefore influence the health and well-being of vegan children. However, the majority of pediatricians is perceived skeptical or negative towards a vegan diet, which can affect vegan parents' trust in their children's doctors and limit or prevent communication. Many parents don't inform pediatricians about their children's vegan diet in order not to be exposed to criticism. The skeptical attitude of doctors could result from legitimate, nutrition-related objections on the one hand and from a lack of knowledge about a vegan diet and dietary supplements on the other. This can lead to health consequences for vegan pregnant women and children due to a lack of information supply and miscommunication. It is not yet clear whether other specialists and medical experts in addition to pediatricians have a negative attitude towards a vegan diet during pregnancy and childhood and therefore offer little or no advice on vegan diets and dietary supplements. If a negative attitude also exists among gynecologists, general practitioners, dieticians and pharmacists, this could have a negative effect on vegans due to a lack of information transfer. The level of information and the associated information provided by medical experts on a vegan diet and dietary supplements during pregnancy and childhood therefore has a significant impact on the adequate nutrient supply of metioned vegans. The level of knowledge among medical experts regarding a vegan diet and dietary supplements has not yet been sufficiently examined. Competent advice on supplementation with dietary supplements is essential for a healthy development during pregnancy and childhood. If information is not provided by medical experts, vegans use other sources of information. It can be assumed that many vegans are insufficiently, incorrectly or not at all informed about dietary supplements and a well-balanced vegan diet due to the different quality of provided information. Dubious sources of information and external influencing factors (social environment, Internet and Social Media, magazines, advertisement etc.) are likely to make parents feel insecure and can affect the health of their children. A lack of expertise on the part of vegan pregnant women and parents (on a vegan diet and dietary supplements) and insufficient support from medical experts (paediatricians, gynaecologists, general practitioners, pharmacists, dieticians) entails possible health risks. The impact of medical expertise and other social, sociodemographic factors (age, social environment and background, Internet and Social Media, advertising etc.), on the diet of vegan pregnant women and children (up to an age of 5 years), as well as on supplementation with dietary supplements needs to be researched. Whether and to what extent external factors influence a vegan pregnancy, infancy and childhood has not yet been scientifically investigated. In addition, there is still no data on the opinion and level of knowledge of consulting medical experts and associated consequences regarding nutrition and the possibility of supplementing dietary supplements for vegans. Results may demonstrate the need for comprehensive counseling on dietary supplements and a vegan diet and highlight the need for better and competent information provision by medical experts to pregnant vegan women and parents of vegan children.

Eligibility criteria: Inclusion Criteria:

A. For vegans:

1. Females/gender-diverse participants (ages 18 and over) who follow/followed a vegan diet during their pregnancy/pregnancies (If there is/was more than one pregnancy, at least during one of their pregnancies)
2. Parents (females/males/gender-diverse - ages 18 and over) who feed/fed their child/children (If there is more than one child, at least one of them) a vegan diet within the age of 0-5 years
3. Vegan mothers/gender-diverse participants (ages 18 and over) who breastfeed/breastfed their infant(s)/child(ren). Answering questions regarding their infant(s)/child(ren) up to an age of 5 years will be included
4. Pregnant and breastfeeding women/gender diverse participants/parents (f/m/d) who make rare exceptions to their vegan diet and a vegan diet of their child(ren) - up to an age of 5 years. Inclusion in the survey depends on the frequency of exceptions → determined through questions/given answers within the survey. Participants that consume animal products maximum twice a month will be included - hence participants who do not make vegetarian or pescetarian exceptions more than twice a month will be included 5.Confirmation of the consent form and participant information ( online - addressing the subjects, purpose and process of the study, opportunities for discussion of further questions, duration of the questionnaire, who is conducting the study, possibility for further inquiries)

B. For medical experts:

1. Gynaecologists, paediatricians, general practitioners, pharmacists, dieticians with or without a consulting focus on vegans
2. Confirmation of the participant information/written consent

Exclusion Criteria:

A. For vegans:

1. Females/gender-diverse participants who change/changed their vegan diet (eat/ate a vegetarian or omnivorous diet) during their pregnancy/pregnancies
2. Parents who do not feed/have never fed their children a vegan diet at least up to an age of 5 years (If vegan mothers followed a vegan diet during their pregnancy, exclusion only relates to questions concerning their children)
3. No confirmation of the consent form and participant information (online) For the inclusion into the study at least one inclusion criteria (plus participant information) must be fulfilled. Exclusion (or not inclusion) will happen if only exclusion 3 is fulfilled. If only 1 or 2 is fulfilled - and 3 is not, participants will be included in the survey. All criteria will be proven by the study physician.

B. For medical experts:

1. Other medical specialists than mentioned in inclusion criteria
2. No confirmation of the participant information/no written consent For the inclusion into the study all criteria must be fulfilled. Exclusion (or not inclusion) will happen if only one exclusion criteria is fulfilled. All criteria will be proven by the study physician.

All participants have do understand the German language in order to answer the questionnaire.

Primary outcomes:
measure: Determination of main influencing factors that affect vegans regarding their diet during pregnancy and when feeding their vegan children (up to an age of 5 years)
timeFrame: The assessment of the study will take place approximately 24 months after participation of vegans/medical experts in the survey
measure: Identify sources of information for vegans on dietary supplements, as a reason for approval or rejection of dietary supplements (during pregnancy, infancy and early childhood) - trustworthiness by ranking
timeFrame: The assessment of the study will take place approximately 24 months after participation of vegans/medical experts in the survey
measure: Viewpoints and general knowledge of medical experts about a vegan diet and dietary supplements (for a vegan pregnancy, infancy and early childhood) should be established
timeFrame: The assessment of the study will take place approximately 24 months after participation of vegans/medical experts in the survey
Secondary outcomes:
measure: Determination of the level of knowledge of vegans on dietary supplements, nutrient deficiency risks and incorrect dosing of dietary supplements during pregnancy, infancy and early childhood (up to an age of 5 years)
timeFrame: The assessment of the study will take place approximately 24 months after participation of vegans/medical experts in the survey
measure: Definition and effectiveness as well as health and health optimization through dietary supplements from a vegan perspective
timeFrame: The assessment of the study will take place approximately 24 months after participation of vegans/medical experts in the survey
measure: Determination of compliance with dietary supplements (DS) during pregnancy, infancy and early childhood as well as the consequences of administration difficulties to vegan children (up to an age of 5 years)
timeFrame: The assessment of the study will take place approximately 24 months after participation of vegans/medical experts in the survey
Other outcomes:
measure: Investigate if gender-specific and socio-demographic differences within the researched group of vegans exist
timeFrame: The assessment of the study will take place approximately 24 months after participation of vegans/medical experts in the survey
Locations:
city: Vienna
country: Austria
facility: University of Vienna - Department of Nutritional Sciences
Study officials:
affiliation: University of Vienna
name: Wolfgang Huber-Schneider
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Vienna
name: Karl-Heinz Wagner
role: STUDY_DIRECTOR
affiliation: Austrian Agency for Health and Food Safety GmbH - AGES
name: Ingrid Kiefer
role: STUDY_DIRECTOR
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