About this trial
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?
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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)
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
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
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)
Disqualifiers
Females/gender-diverse participants who change/changed their vegan diet (eat/ate a vegetarian or omnivorous diet) during their pregnancy/pregnancies
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)
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.
Other medical specialists than mentioned in inclusion criteria
Trial 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).
Trial design
Cohort
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
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)
Influence by medical experts or other influences (social environment, Internet and Social Media, magazines etc.) concerning the decision for or against a vegan diet should be clarified. Depending on the source of information, possible risks of a vegan diet during pregnancy, infancy and early childhood can be misjudged.
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
It should be determined which information on dietary supplements (during pregnancy, infancy and early childhood) is used and whether this information appears trustworthy or causes uncertainty. Information received affects selection, intake, or avoidance of certain dietary supplements. The health impact of selected sources of information on dietary supplements can be made visible. Medical expert advice and other opinion-forming aspects (social environment, Internet and Social Media, magazines etc.) should be ranked according to their relevance. The main source of information should be identified. This can be an important approach for the improvement of information supply on dietary supplements in the vegan diet and for minimizing risks preventively. By recognizing the source of information that is classified as the most important for vegans, the main causes of frequent inadequacies in the supply of information can be identified and positively changed.
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
The impact of expert opinion and knowledge on the vegan diet regarding their advice on dietary supplements for vegans (during vegan pregnancy, infancy and early childhood) should be clarified. Statistically evaluated results of the survey should allow conclusions about the influence of information supply by medical experts on nutrient supply, of vegan pregnant women and growing children (up to an age of 5 years). A possible misinterpretation of the health risk of a vegan diet during pregnancy, infancy and early childhood due to insufficient knowledge of dietary supplements could increase health risks. A negative basic attitude towards a vegan diet influences the relationship of trust between vegans and their physicians. If there is no advice on dietary supplements, health risks can increase.
Secondary outcomes
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)
If the risk of incorrect dosing of dietary supplements is misjudged by vegans during pregnancy, infancy and early childhood, nutrient deficiencies or overdose with dietary supplements become likely. Risks of a nutrient deficiency due to missing intake or incorrect selection of dietary supplements because of a lack of knowledge should also be cognizable. Avoiding these circumstances would require a better supply of information for vegans by medical experts (paediatricians, gynaecologists, general practitioners, pharmacists, dieticians). If the risk of incorrect dosing is misjudged by medical experts the quality of advice on dietary supplements could suffer. Imprecise advice could affect the relationship of trust between medical experts and vegans as well as the nutrient supply during pregnancy, infancy and early childhood.
Definition and effectiveness as well as health and health optimization through dietary supplements from a vegan perspective
The perception of what a dietary supplement can do, whether it is comparable to medicine or food, or whether a positive/negative effect can be expected, depends on the level of knowledge of vegans about dietary supplements. How vegans perceive dietary supplements and how they rate their effectiveness influences their intake behavior. What health means for vegans and whether dietary supplements are perceived as health-promoting from a vegan perspective should also be clarified. Determining what is meant by health optimization for vegans creates an understanding of the intake or rejection of dietary supplements. Rejection of dietary supplementsdue to health concerns can indicate insufficient education about health benefits.
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)
It should be investigated whether vegans consider regular intake or administration of DS during pregnancy and early childhood to be effective. It should be clarified whether dosage forms (e.g. drops, pills, capsules etc.) of existing DS for infants and children represent an unsettling factor for the vegan parents, which in turn increases the risk of incorrect dosing and resulting nutrient deficiencies (wrong administration, wrong dosing etc.). Medical experts should also evaluate the options of dosage forms and the compliance as well as the consistency of administration by parents to the vegan child. This should clarify whether dosage forms of DS can have an impact on the regularity of administration and subsequently on the development of nutrient deficiencies. Statements about the regularity, duration of intake and compliance of DS are intended to allow conclusions about the supply of consumers with the corresponding DS and to show any potential dangers or health-enhancing effects.
Other outcomes
Investigate if gender-specific and socio-demographic differences within the researched group of vegans exist
Different perceptions of and opinions on the vegan diet and DS (during pregnancy, infancy and early childhood) between vegan women, men, gender-diverse people as well as between vegans in and outside the city should clarify differences in nutrient deficiency-associated risks of a vegan diet and the intake of DS. Other socio-demographic characteristics such as age, education, income, employment status etc. should also be included. Risk deviations could exist due to unequal access to information.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Wolfgang Huber-Schneider
Lead sponsor
University of Vienna
Sponsor institution
University of Vienna
Collaborator
Austrian Agency for Health and Food Safety GmbH - AGES
Collaborator