Influencing a Vegan Diet and the Intake of Dietary Supplements During Pregnancy and Childhood

NCT06669819 | Recruiting

• 1 other identifier: VedieS
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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?

Conditions

Vegan Diet; Pregnancy; Dietary Supplements; Childhood

Keywords

vegan; pregnancy; pregnant; childhood; dietary supplements; parents; medical experts; paediatrician; gynaecologist; general practitioner; pharmacist; dietician

Outcome Measures

Primary Outcomes (3)

• 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.

  The assessment of the study will take place approximately 24 months after participation of vegans/medical experts in the survey

• 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.

  The assessment of the study will take place approximately 24 months after participation of vegans/medical experts in the survey

• 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.

  The assessment of the study will take place approximately 24 months after participation of vegans/medical experts in the survey

Secondary Outcomes (3)

• 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)

  The assessment of the study will take place approximately 24 months after participation of vegans/medical experts in the survey

• Definition and effectiveness as well as health and health optimization through dietary supplements from a vegan perspective

  The assessment of the study will take place approximately 24 months after participation of vegans/medical experts in the survey

• 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)

  The assessment of the study will take place approximately 24 months after participation of vegans/medical experts in the survey

Other Outcomes (1)

• Investigate if gender-specific and socio-demographic differences within the researched group of vegans exist

  The assessment of the study will take place approximately 24 months after participation of vegans/medical experts in the survey

Study Arms (2)

vegan pregnant women and vegan parents

medical experts

paediatricians, gynaecologists, general practitioners, pharmacists, dieticians

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• A. For vegans:
• 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
• B. For medical experts:
• Gynaecologists, paediatricians, general practitioners, pharmacists, dieticians with or without a consulting focus on vegans
• Confirmation of the participant information/written consent

You may not qualify if:

• A. For vegans:
• Females/gender-diverse participants who change/changed their vegan diet (eat/ate a vegetarian or omnivorous diet) during their pregnancy/pregnancies
• B. For medical experts:
• All participants have do understand the German language in order to answer the questionnaire.

Sponsors & Collaborators

• Wolfgang Huber-Schneider: lead
• University of Vienna: collaborator
• Austrian Agency for Health and Food Safety GmbH - AGES: collaborator

Study Sites (1)

University of Vienna - Department of Nutritional Sciences

Vienna, Austria, 1090, Austria

RECRUITING

Related Publications (25)

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Related Links

• estimated number of vegans in Austria (vegan society Austria)
• children born in Austria in 2023 (Statistik Austria)

Study Officials

• Wolfgang Huber-Schneider

  University of Vienna

  PRINCIPAL INVESTIGATOR

• Karl-Heinz Wagner

  University of Vienna

  STUDY DIRECTOR

• Ingrid Kiefer

  Austrian Agency for Health and Food Safety GmbH - AGES

  STUDY DIRECTOR

Central Study Contacts

Wolfgang Huber-Schneider

CONTACT

00436767773179; a0225229@unet.univie.ac.at

Karl-Heinz Wagner

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD Student

Study Record Dates

• First Submitted: October 28, 2024
• First Posted: November 1, 2024
• Study Start: October 1, 2023
• Primary Completion: July 31, 2025
• Study Completion: December 1, 2025
• Last Updated: April 1, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)