PARTICIPANT INFORMATION SHEET
Section A: The Research Project
1. Title of project
The Effects of Endurance Training on Body Composition and Cardio-Metabolic Responses according to a Genetic Predisposition to Obesity.
2. Purpose of study
Body mass can be influenced by a variety of factors including biological, environment, lifestyle and genetic influences. The influence of genes is one aspect which can be significantly influenced through the benefits of exercise. Therefore, the purpose of this study is to gene screen a randomly selected sub-sample population to identify any genetic predispositions and consider the cardio-metabolic responses to 8-weeks of endurance training.
3. Who are the researchers?
Dr Dan Gordon (email@example.com)
Chloe French (firstname.lastname@example.org)
This research is being conducted as part of my postgraduate Master’s degree at Anglia Ruskin University.
4. Why have I been asked to participate?
- You are invited to participate in our research because you are either male or female, between the ages of 18-60.
- You are currently in good health and must be free from disease, for example, free from conditions such as diabetes, respiratory and cardiovascular problems.
- You currently run a minimum of 3x 5km runs per week.
- You are happy to provide evidence weekly of your training for 8-weeks.
- You have access to a smart watch which allows you to record your heart rate.
- You have access to set of bathroom weighing scales and a tape measure.
Please read the information set out in below and ask any questions you have. We will answer any questions you have honestly before you consent to participate.
5. How many people will be asked to participate?
25 people will be recruited to participate in this study. They will be accepted providing they meet the participant criteria. If more participants volunteer than required, the participants will be randomly selected.
6. Do I have to take part?
You are under no obligation to take part and you can therefore refuse to take part without giving a reason. You should not feel forced into taking part in this study.
7. Has the study got ethical approval?
The study has ethical approval from the Faculty of Science and Engineering Research Ethics Panel at Anglia Ruskin University.
8. Has the organisation (ARU) where the research is being carried out given permission?
The research is being carried out at ARU and permission from them has been granted. General permission has been granted to approach participants, however, there is no obligation placed on them [participants] by the organisation to take part, and it is the decision of each person whether they would like to take part in your research.
9. Legislation relating to this study
All collection of saliva samples for genetic assessment will be conducted in compliance with the Human Tissue Act (2004). All data will be collected and stored in accordance with the General Data Protection Regulations (2018).
10. Source of funding for the research, if applicable
11. What will happen to the results of the study?
All information collected from you during your participation in this research will be anonymised. Your personal information will not be distributed in any way. The final report will include your data – but it will not be possible to identify you from the data. There will also be the potential for this to be presented at a conference, but it will not be possible to identify to you from your data.
12. Contact for further information
Please contact Chloe French using the following email address: email@example.com
Section B: Your Participation in the Research Project
1. What will I be asked to do?
In order to assess your eligibility for this study, please complete the eligibility questionnaire.
Location: All testing and training will take place at a location of your choice in your local area. It is your responsibility to make sure you are carrying your runs out in a safe environment, while following local government COVID-19 guidelines and restrictions.
The training will take place over an 8-week period, with pre-testing taking place in the week prior and further post-testing on completion of the 8-weeks training period. You will repeat the same protocols for pre- and post-testing, keeping the study as valid as is possible. Please carry out a warm-up and cool down either side of your runs. Please maintain sufficient hydration and nourishment around your training. Please make sure you are wearing appropriate kit for your runs (e.g. running shoes, shorts/leggings, t-shirts, layers if appropriate, hi-vis clothing if appropriate).
Pre- and Post-Testing:
On the morning of each testing run:
Please weigh yourself first thing in the morning before consuming anything, with footwear removed, and after you have been to the toilet.
Please then use a tape measure to measure your waist circumference at the narrowest part of your waist, above your belly button.
- Please run the time trials as fast as possible.
- The 5km time trial must be completed first.
It is your responsibility to complete these tests within a 1-week time period, which can be completed at a time that suits you.
It is likely these tests combined will last approximately 1-hour in total for the week.
You will NOT be given a training programme, but rather you will be asked to continue your training as normal during the 8-week period. Based upon you training, you will be assigned to either a low or high load training group. On completion of all 8 weeks, you will then complete your post-testing the following week. During the 8-week training period, you will need to provide evidence of all training sessions (please aim for a minimum of 3x 5km runs per week) on a weekly basis recorded using a running application. You will need to have access to a running application, a smart watch and the ability to record your heart rate. You will need to either share the data with the researcher (Chloe) via the application, or email screenshots across. This will include distance, duration, pace and average heart rate. This should include one of the following or an equivalent app can be discussed:
Map my Run (https://www.mapmyrun.com)
Nike Run Club (https://www.nike.com/nrc-app)
You will receive additional instructions regarding this closer to the time. You will be provided with a personal link to a Google Sheets document to enter all relevant training data and information. Please be aware, it is easier to access and input the data using a computer as opposed to a mobile.
There is the potential for you to be selected for a genetic screening. A sub-sample population will be randomly selected for genetic analysis that will provide a representation of the entire study sample consisting of approximately 10 participants from the low and high load training groups. There is no guarantee that you will be selected. If you are selected, a kit will be sent to you directly from an external company, Mudho Health Ltd, to provide a saliva sample for genetic analysis. The kit will include a small cotton swab to collect a sample of cells from the inside surface of the cheek. You will then need to return the sample via post directly to Mudho Health Ltd for the sample to be analysed. If you are selected, the sample will be screened for 2 genes, the FTO gene and PPAR-gamma gene, which have been identified as having an influence BMI, body fat percentage and waist circumference indicating a genetic predisposition to obesity. You are welcome to receive your results on completion of the study. You will receive additional information regarding this closer to the time.
2. In relation to this specific research project, we need to make you aware of the following:
We do not need your personal data at any stage of this research project
We are responsible for the personal data you give to us as a:
(We are in sole control over the research)
Who are we?:
Dr Dan Gordon
Chloe French on behalf of Anglia Ruskin University.
3. I will be asking you for the following information:
- Name/Contact Details
- Anthropometric measures, including height and mass
Sensitive and Personal Data:
- Racial/Ethnicity data
- Genetic/ Biometric data
No data will be collected from any data held about participants from existing records.
4. What will happen to your data?
The data collected will be pseudo-anonymised using a code. Pseudo-anonymisation means that identifiable information, such as people’s names, will be removed from the data and a code will be assigned. The data will, however, still be able to be linked together by the researcher should this be required.
Any data collected will be held securely. The data will be shared with the researcher and the supervisor involved, but it will only be shared in an anonymised format.
If you are randomly selected for the gene screening, your name, address and ID code will be shared with Mudho Health Ltd who will be carrying out the gene analysis. The researcher will receive the results back in an anonymised format where the results are linked to your ID code.
You will be anonymised as a participant in the research. However, even though every attempt will be made to ensure they are anonymous, there is a chance they could be identified by their peers or colleagues.
If you would like to receive a copy of your data, this will be fulfilled once the study is complete.
5. Will I receive any payment to take part in the research?
There will be no financial payment received from taking part in this study. If you are a student at ARU, there is an opportunity to gain employability credits.
6. Are there any possible disadvantages or risks to taking part?
There are no disadvantages to taking part in this study and there are no inherent risks beyond those encountered in through your regular training.
7. What are the likely benefits of taking part?
There is the opportunity to gain valuable experience that could benefit your own learning in this study. You are also welcome to request your results from the testing at the end of the study. There is the potential for Anglia Ruskin University students to gain employability credits from participation in this study if so desired.
8. Can I withdraw at any time, and how do I do this?
You are free to withdraw at any time, without providing a reason. Should you not wish any data belonging to you, that has already been collected, to be included in the final research report, or you do not feel comfortable withdrawing directly in person, please email firstname.lastname@example.org. All data relating to you, the participant will then be removed. Additionally, if you consent to your data being used in this study, please grant permission. You are free to withdraw your data, until the last approximate time where you have completed all of your testing, given it will not be possible once we have written the research up for the major project.
Note: This study uses an ‘Opt in’ consent and participation approach. If you wish to participate in this study, you must complete the consent form and return it to; email@example.com. If the consent form is not returned (Opting In), it will be assumed you are not agreeing to participate.
9. What will happen to my data?
Our general privacy notice explaining our use of your personal data for research purposes is available here:
Please visit this link for information about how long we keep your data, how we keep your data secure, how you can exercise your rights over your data, and make a complaint over our use of your data.
10. Can I withdraw my data from the study?
I can only remove your data if you ask me before I anonymise it. After this, I will not know which is your data so will not be able to do this.
11. Whether there are any special precautions you must take before, during or after taking part in the study
You must have access to a set of bathroom weighing scales, a tape measure and a smart watch and are able to record your heart rate to take part in this study. 24-hours before testing you will be asked to avoid alcohol and any vigorous exercise. You will be asked to record your training using a running app as discussed above to record a minimum of 3 sessions per week (minimum 3x 5km’s). You will be asked to provide the data from the time trials on the same day or subsequent day of testing. You will be asked to email screenshots of your data or share your activity via the app from all training sessions on a weekly basis. You will need to maintain your hydration at your own leisure, but you will be asked to avoid caffeinated and sugary-based drinks 3-6-hours prior to testing. Please wear appropriate sport clothing (E.g. running shoes, shorts/leggings, t-shirts, layers if appropriate, hi-vis clothing if appropriate). There are no special precautions post-testing.
12. Will I pass onto anyone else what you have told me?
All information collected from you during your participation in this research will be anonymised. Your personal information will not be distributed in any way. If you are selected for the gene screening, your name, address and ID code will be provided to Mudho Health Ltd for the kit to be sent directly to you. When the researcher receives your results back from Mudho Health Ltd, your results will be linked to your ID code. The final research report will include your data – but it will not be possible to identify you from the data.
13. Summary of research findings
Once the study is completed and the findings have been submitted as part of the Master’s project, you can have a copy of the findings if you request it.
14. Contact details for complaints
If you have any complaints about the study, please speak to Chloe French using the following email address firstname.lastname@example.org. If you do not feel comfortable approaching the researcher, you can speak to the supervisor Dan Gordon at email@example.com to try and reach an informal resolution.
If no resolution can be made, you can follow details on Anglia Ruskin University’s complaints procedure.
Email address: firstname.lastname@example.org
Postal address: Office of the Secretary and Clerk, Anglia Ruskin University, Bishop Hall Lane, Chelmsford, Essex, CM1 1SQ.
PARTICIPANTS SHOULD BE GIVEN A COPY OF THIS TO KEEP,
TOGETHER WITH A COPY OF THE CONSENT FORM.
Date 4 February 2021