Project Title: Investigating the impacts on psychosocial factors and diet quality of following gluten-restricted diets in Australian adults without Coeliac disease. 

Investigators and Other Project Personnel
Chief Investigator
Dr Stephen Keenan, School of Health Science, Department of Nursing and Allied Health, Swinburne University of Technology
Telephone: (03) 9214 5383; email: skeenan@swin.edu.au

Sun Jun Lee, School of Health Science, Department of Nursing and Allied Health, Swinburne University of Technology

Olivia Peake, School of Health Science, Department of Nursing and Allied Health, Swinburne University of Technology

Welcome
You are invited to take part in a research study investigating general levels of anxiety amongst Australian adults (aged 18 years and over) who do and do not follow gluten-restricted diets, as well as differences in overall diet quality between these two groups. You are eligible to participate in this project if:

(i) you are 18 years of age or over
(ii) you do not have a diagnosis of Coeliac disease
(iii) you have not received advice from a medical professional to restrict or avoid gluten intake

You are not eligible to participate in this project if:

(i) you are under 18 years old
(ii) you have a formal diagnosis of Coeliac disease
(iii) you have received advice from a medical professional to restrict or avoid gluten intake
(iv) you have been diagnosed formally with other conditions that may necessitate restriction of foods with gluten (e.g. wheat allergy, inflammatory bowel disease [Ulcerative Colitis or Crohn's disease], irritable bowel syndrome)

This study will also explore the psychosocial impacts of following a gluten-restricted diet, as well as levels of adherence to, knowledge pertaining to, and information sources used to guide gluten-restricted diets. You have been invited to participate as you have expressed an interest in participating by following the link to this survey.

What this project is about and why it is being undertaken

This research project is designed to explore the dietary habits and related anxiety levels among healthy Australian adults who follow a gluten-restricted diet without a diagnosis of Coeliac disease. Gluten-restricted diets have surged in popularity, often perceived as a healthier lifestyle choice or as a means to manage non-specific gastrointestinal symptoms. Despite this trend, the psychological and nutritional implications of such dietary restrictions in non-Coeliac populations have not been thoroughly investigated.

The study will examine whether adherence to a gluten-restricted diet correlates with different levels of general anxiety, as measured by the GAD-7 questionnaire. It will also assess the differences in diet quality between those who do and do not follow a gluten-restricted diet. Previous research suggests that dietary restrictions can influence mental well-being, but data on the implications of voluntary gluten avoidance are sparse. By assessing general anxiety levels and dietary quality among individuals with self-imposed gluten restrictions, the project seeks to provide insights into the broader associations of this dietary choice. In addition, this research will evaluate participants' knowledge of gluten-restricted diets and the sources from which they obtain their dietary information. Understanding the motivations behind choosing a gluten-restricted diet and the level of adherence will contribute to a better understanding of this dietary trend in the Australian context.

Through this study, we aim to inform healthcare professionals, dietitians, and the general public about the potential benefits and drawbacks of a gluten-restricted diet in individuals without Coeliac disease. The data collected will help to guide dietary recommendations and develop educational resources that support informed decision-making regarding gluten-restricted lifestyles. This research is timely and significant given the increasing number of Australians adopting gluten-restricted diets for reasons other than Coeliac disease.

What participation will involve – time, effort, resources, costs, compensatory payments, etc

Participation in this project will require you to engage in a detailed online survey anticipated to take approximately 20 minutes to complete. The survey comprises multiple sections aimed at understanding your dietary habits and their psychological impacts.

The initial part of the survey will gather demographic information, such as age, gender, and educational background.

Following this, you will be asked to respond to the Generalized Anxiety Disorder-7 (GAD-7) questionnaire, a validated tool that assesses the frequency of anxiety symptoms experienced over the past two weeks. Those who follow a gluten-restricted diet will then be asked to answer additional questions regarding their motivations for this dietary choice, their adherence levels, and the duration of their gluten-restricted diet, as well as their knowledge of gluten containing foods. This segment will also delve into the sources from which you receive information about gluten-restricted diets and the impact this diet has on your daily life and feelings towards food. All participants will also be asked to complete a short dietary questionnaire that consists of 22 questions related to consumption habits compared to the Australian Guide to Healthy Eating recommendations.

There are no direct costs associated with participating in this study, and there are no compensatory payments being offered for participation in this study.

Participant rights and interests – Risks & Benefits/Contingencies/Back-up Support

There are some risks associated with participation in this study. Some individuals may feel a level of discomfort or triggering caused by the content of this survey, in particular the anxiety screening questionnaire or psychosocial questions associated with following a gluten-resricted diet. All participants will be provided with contact details of support services at the end of the survey, and you are encouraged to contact these services should you feel the need (these contact details can also be seen below). We also encourage those who do restrict gluten within their diet for health reasons, but have not consulted a health professional to investigate this, to consult with their primary health care provider.

There are no direct benefits expected to the participant with regards to participating in this study, although it may raise awareness of your overall diet and health. Nonetheless, there are likely to be benefits to the wider community. This study will contribute to the understanding of the implications of gluten-restricted diets in individuals without Coeliac disease. By examining the diet quality, psychological well-being, and lifestyle impacts associated with voluntary gluten restriction, the findings can inform public health strategies, dietary guidelines, and support services. Furthermore, this research has the potential to guide healthcare professionals in advising patients considering or currently following a gluten-restricted diet without medical necessity. The insights gained could lead to more nuanced discussions around dietary choices, mental health, and overall well-being, potentially influencing dietary recommendations and interventions. Ultimately, the study aims to enrich community knowledge, fostering a more informed and health-conscious society with access to evidence-based advice on the effects and management of gluten-restricted diets.

For those individuals who are reading this information and consent form and who may be concerned about their eating behaviours, but do not wish to participate in this study, we encourage you to explore the below resources.

Beyond Blue
 www.beyondblue.org.au Ph: 1300 22 4636

Lifeline
www.lifeline.org.au Ph: 13 11 14

Participant rights and interests – Free Consent/Withdrawal from Participation
 Participation in this study is completely voluntary. In order to participate, you are required to thoroughly read this information and consent form and indicate that you consent to participate using the applicable tick boxes below. You are encouraged to ask any questions you may have regarding this study prior to participating by contacting the chief investigator. Should you choose to participate, you are welcome to withdraw from the study at any time without judgment prior to the final submission of your survey (at which point we will be unable to retrieve and delete your data due to the anonymous nature of the survey). Any partial data that you have already provided will be withdrawn from any data analysis (i.e. only completed survey responses will be analysed). Should you wish to withdraw from this study, simply close your browser at any time prior to finalizing your submission.

Participant rights and interests – Privacy & Confidentiality
All data obtained from the survey is anonymous and non-identifiable. All data will be stored using password protected programs. The data will be stored electronically for an indefinite period as it may be included in future related research projects, or those in the same general area of research. Any data obtained from the research study that is used in future research by the research team will remain non-identifiable. The data collected will only be accessible by the research team. All outcomes will be published/reported as group data only, meaning no individual will be identifiable from these publications/reports. By consenting to participate in this study are consenting to allow this anonymised data to be used in future, related research by the research team.

Research output
The group data from this study will be used in the student researchers’ coursework as part of their Masters of Dietetics qualifications. Additionally, the research output may be published in peer-reviewed journals or presented at conferences. Results will be available upon request from the principal investigator once the project is completed.

Complaints & Further information about the project – who to contact
If you would have any concerns or complaints about the conduct of this product, or would like further information about the project, please do not hesitate to contact: Dr Stephen Keenan Swinburne University, John Street, Hawthorn, Vic, 3122 Email: skeenan@swin.edu.au

This project has been approved by or on behalf of Swinburne’s Human Research Ethics Committee (SUHREC) in line with the National Statement on Ethical Conduct in Human Research. If you have any concerns or complaints about the conduct of this project, you can contact:

 Research Ethics Officer, Swinburne Research (H68),
 Swinburne University of Technology, P O Box 218, HAWTHORN VIC 3122 Australia. Tel (03) 9214 3845 or +61 3 9214 3845