Participant Information Statement
We need to make sure you have a full understanding of what AIM4ME is all about so we have attached an Information Statement about the project.
Feel free to print or download a copy and store it for future reference Information Statement.
It is important to read this Information Statement, as it clearly describes the research, why we are doing it, what is involved, what you can do if you want to withdraw, how your information is protected and how you can contact us if you need to. It also contains contact details where you can get more information.
Information Statement for the Research Project
The Advice , Ideas and Motivation for My Eating (AIM4ME) study
You are invited to participate in the research project identified above which is being conducted by a team of researchers led by Professor Clare Collins from the School of Health Sciences at the Univeristy of Newcastle. This study is funded by the National Health and Medical Research Council (NHMRC).
Why is the research being done?
This study is being conducted to test the effectiveness of an online intervention for young adults using varying levels of technology-delivered real time personalised feedback on an individuals dietary intake. AIM 4 Me aims to motivate young adults to improve their diet quality and eating habits.
Who can participate in the research?
Aim4Me aims to recruit 2,570 young men and women aged 18-24 years around Australia.
Participating in this research is suitable for you if :
· You have a BMI >18.5kg/m2
· You have access to a computer, and or a tablet (e.g. ipad) and a smartphone (e.g. Android, iPhone, SamsungGalaxy etc) with e-mail and internet connection for the next 12 months
· You live in Australia
Participating in this research is not suitable for you if:
· You are currently pregnant, or planning to conceive in the next year
· You have one of the following medical condition(s): diabetes controlled by insulin, heart failure, chronic respiratory disease, pancreatitis, renal disease, liver disease or similar conditions that may be exacerbated by a change in diet
· You have been diagnosed or treated for an eating disorder
· You have special dietary requirements or dietary restrictions due to food allergies or intolerances
· You are not proficient in English
What choice do you have?
Participation in this research is entirely your choice. Only people who give their informed consent can participate in this study. Your decision will not disadvantage you or your current or future relationship with the University of Newcastle. If you do decide to participate, you may withdraw from the project at any time without giving a reason and have the option of withdrawing all information/data that identifies you.
Where practical, you can use a psyedonum when using the service. However in some circumstances, it will be impractical to use a pseudonym. One example is where we contact you for an online consultation with a dietitian.
What would you be asked to do?
Once you have read the information statement and the terms and conditions and agree you will be directed to an online elibilitiy screen survey. If you are eligible, you will be asked to provide contact details and then consent online prior to commencing.
Aim4Me will run for one year. At first you will be asked to complete assessment questionnaires on your background (including ethnicity, education, employment, postcode), height, weight, dietary intake (Australian Eating Survey), alcohol use, smoking (abstinence), food security, cooking, physical activity, quality of life, sleep, sitting time, ehealth, social eating and dietary habits, social desirability, social approval,self regulation and motivation, depression, anxiety and stress.
At the completion of these questionnaires you will be randomly allocated to either the control group or one of the two intervention groups where you will then be directed to a specific web page.
Random means that you have an equal chance of being allocated to one of the three groups. Personal preference for group allocation cannot be taken into account.
If allocated to the control group you will be asked to do the following:
1. Complete the Healthy eating quiz (HEQ), a five-minute online nutrition assessment tool on four occasions across the year (baseline 3, 6, and 12 months).
2. Complete the Australian Eating Survey (AES) on three other occasions across the year (3, 6, and 12 months). The survey asks you about the foods that you currently consume.
If allocated to the two intervention groups (Group 2 and 3) you will be asked to do the following:
3. Complete the Australian Eating Survey (AES) on three other occasions across the year (3, 6, and 12 months). The survey asks you about the foods that you currently consume. This survey automatically generates a feedback report on the nutritional adequacy of your diet and you will be provided with a copy of the report.
4. Access the AIM 4 ME website which provides an online resource library containing information and tools related to healthy eating and resources to set, plan and self monitor goals.
If allocated to Group 3 you will be asked to do the following extra :
5. You will receive a one-on-one brief online video counselling session by a dietitian (30 minutes) to assist you in making changes to your diet based on feedback from the AES report. The video call application Vsee will be used for the video coaching sessions. You will be asked to download and install the application onto your computer or mobile device (instructions will be provided). With your permission this session may be recorded and the high level content evaluated by a member(s) of the research team. All information discussed between yourself and the dietitian will remain confidential.
All participants will be asked to:
· Complete assessment questionnaires on three other occasions across the year (3,6, and 12 months). You will receive scheduled reminders to complete these questionnaires.
· Complete a 24 hour recall, an online assessment tool that asks you what you ate the day before (baseline, 3, 6 and 12 months).
How much time will it take?
The HEQ will take 5 minute and the AES takes ~15 mins to complete. The assesment questionnaires at each timepoint will take around 30 minutes (on the computer device) or 45 minutes on a phone. If you are allocated to group 3, the one off video online counselling session will be of approximately 30 mins duration. The online 24 hour recalls will take around 30 minutes.
What are the risks and benefits of participating?
· We cannot promise that you will receive any benefits from participating in this study. However, a desired outcome of this research is improving diet quality and eating habits in young adults. Upon completion of the questionnaires you will automatically go into a gift voucher prize draw. Each prize draw has a 1 in 100 chance of winning and the value will increase over time,starting at $100 at baseline and increasing to $400 at 12 months.
· Each time you complete the assessment questionnaires and the AES you will earn just under 200 points. These points will go towards donating to a charitable cause to support youth or young adults. The AIM4ME study will convert your points to a monetary value. You will be notified of the value online when this occurs.
· If you are a winner of the prize draws you will also be given the opportunity to contribute your earnings to a chariatable cause, however you are under NO obligation to do so. The AIM4ME study will have a list of charites for e.g. Ozharvest that you can choose from.
Any personal risks associated with this research project have been considered and measures have been taken to minimise these risks to the utmost. We ask any participant who feels concerned about undertaking the above mentioned tasks to contact either the research team using the details provided on this information sheet.
Some of the questions we ask in the questionnaires are about your mental health. If you are concerned about your mental health or are feeling distressed after completing the questionnaires, it may help to talk with someone about how you have been feeling. There are a number of different ways that you can do this, including the following telephone or online options:
1. Call Lifeline 13 11 14 (24 hour) Website: www.lifeline.org.au/
2. Call beyondblue 1300 22 4686; Website: www.beyondblue.org.au/
3. Call Kids Helpline (Age 5-25 years) 1800 55 1800 (free call - 24 hour). Website: https://kidshelpline.com.au
Your local general practitioner (GP) can refer you to a health practitioner including your local headspace centre (www.headspace.org.au) which provides free counselling to young people Australia wide.
What information will be collected?
The information we collect will include your:
· Phone number;
· Health status; and
· Access to technology.
Why is the information collected?
We collect your information for purposes that include to:
a) Conduct research;
b) provide personalised feedback about an individual’s dietary intake; and
c) motivate young adults to improve their diet quality and eating habits.
How will your privacy be protected?
All the information collected from you for the study will be treated confidentially and only authorised members of the research team will have access to it. All electronic information will be stored in password protected files on a secure, University hosted online platform which access is available only to authorised research team members and IT development team that conducts maintenance on the platform. Identifying information will be removed and replaced with a numerical code for the analysis of the raw data. All data collected as part of your participation will be retained for at least 5 years at the University of Newcastle, If after this time, the data is no longer required it will be disposed of in accordance with the University of Newcastle’s Records Management Policy.
How will the information collected be used?
The results of this study will be reported at national and international conferences and in scientific publications.You will not be identified in any publication or reports arising from this study. You will receive a brief written summary of results via email from the research team at the conclusion of the study. Non-identifiable data may be shared with other parties to encourage scientific scrutiny, and to contribute to further research and public knowledge, or as required by law. The data collected in this study will contribute to Erin Clarke’s PhD thesis.
How can I access and correct my information?
You may request access to the personal information that you provided to us at any time, and you can request that we correct that personal information. We will give you access to your personal information, and will take reasonable steps to correct it if we consider that it is incorrect, unless there is a law that allows or requires us not to. If we refuse to give you access to your personal information, or to correct it, we will notify you in writing and will provide reasons.
What do you need to do to participate?
Please read this Information Statement and the terms and conditions on the AIM for me landing page. Be sure you understand its contents before you consent to participate. If there is anything you do not understand, or you have questions, contact the researcher. If you would like to participate then agree to the terms and conditions and information statement and complete the online eligibility screening survey
If you would like further information please contact Professor Clare Collin(email@example.com
or 02 4921 5646).
The Research Team
AIM4ME Chief Investigator
Professor Clare Collins
School of Health Sciences, Faculty of Health and Medicine University of Newcastle, Callaghan, NSW 2308
T: (02) 4921 5646 ; firstname.lastname@example.org
University of Newcastle
· Professor John Attia
· Dr Melinda Hutchesson
· Professor Robin Callister
· Associate Professor Tracy Burrows
· Professor Billie Bonesvki
· Professor Chris Moran
· Erin Clarke; PhD candidate
· Professor Helen Truby
University of Queensland
· Professor Leanne Hides
· Associate Professor Deborah Kerr
Complaints about this research
This project has been approved by the University’s Human Research Ethics Committee, Approval No. H-2017-0087. Should you have concerns about your rights as a participant in this research, or you have a complaint about the manner in which the research is conducted, it may be given to the researcher, or, if an independent person is preferred, to the Human Research Ethics Officer, Research & Innovation Services, The University of Newcastle, University Drive, Callaghan NSW 2308, Australia, telephone (02) 4921 6333, email Human-Ethics@newcastle.edu.au.
Individuals may raise concerns and complaints about the way in which the University has handled their personal or health information. A privacy complaint will be considered under the University's complaint handling processes. For more information, see the University’s Privacy Management Plan. If the complaint remains unresolved, you have the option of notifying the Information and Privacy Commission (IPC). Contact details can be found at IPC’s website: www.ipc.nsw.gov.au.
Terms and conditions
By signing up to AIM 4 ME users acknowledge the following points:
1. Participants will be provided with an online Information Sheet that explains the nature and purpose of the study and any risks involved.
2. Participants must have read the Information sheet before they consent to participate.
3. Prior to consenting you will be asked to provide information such as your name, email address and contact number. This information will be stored securely.
4. Participants must complete the eligibility screening questionnaire to determine if they are eligible, for those who are eligible they will be able to continue. For those who require medical clearance will need to get written documentation from their General Practioner.
5. Participants' involvement in the study may or may not be of benefit to them.
6. Participants are free to withdraw from the project at any time without explanation or prejudice and are free to to withdraw any unprocessed data they have provided.
7. Participants can withdraw by contacting the research team
8. All the information gained in the study will be treated confidentially
9. All the possible effects of participating will be explained to the participants' satisfaction;
10. The project is for the purpose of research
11. The confidentiality of the information provided by participants will be safeguarded subject to any legal requirements
12. Data provided by participants will be de-identified and stored at University of Newcastle and will be destroyed after five years
13. Participants may be contacted by the AIM 4 ME research team in regard to future research related to this project or similar project
14. Participants will be receiving emails or SMS communication throughout the course of the study and will need to contact email@example.com if they wish to stop receiving any emails or SMS communication
15. All the content on the AIM 4 Me website is copyright. You you may print or download the AIM 4 Me content for your personal and non-commercial use only during the study.
16. You must not copy the content to individual third parties or use it for other purposes.
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