Volunteers interested to take part in this research study, must meet the following criteria:
You must be a female endurance athlete in long-distance running, orienteering, cycling, triathlon, cross-country skiing, or biathlon.
You must be between 18 and 35 years old.
You must be active in competitions and exercise at least 5 times a week.
You do not smoke or suffer from any chronic diseases.
If you continue after part 1 of the study:
You should not use any hormonal birth control during the project period and any hormonal birth control should be discontinued at least 6 weeks before the first data collection.
You should not be pregnant or have plans to get pregnant during the project period.
You have indications of relative energy deficiency but not an eating disorder, since this requires a different type of treatment
Your participation matters for our research, for society and for individuals. With your participation, you will help us to improve the existing preventive methods and the treatment of some related health issues, as well as increase the athletes’ potential performance in sports.
The project is adjusted to the current COVID-19 pandemic situation and does not involve any physical contact with other individuals.
What does the project involve?
Initially, participation in the project involves answering an online questionnaire with questions related to exercise, diet, body, sports injuries, illness, and menstruation (part 1). If you meet a set of criteria, you will be offered participation in part 2 of the project, which includes the intervention itself (if you wish, it is possible to participate in part 1 only). Before and after the intervention, participants must complete a test period. This means that you are going to record your diet and exercise for seven consecutive days, by weighing and recording the food you eat as well as using an accelerometer that measures your activity level and a heart rate monitor during your training. In addition, you are going to measure your body composition (you will borrow all necessary equipment which will be sent by mail). In the same week, you are asked to fill out a new questionnaire with questions related to sports nutrition, performance, recovery, motivation, and quality of life. Then begins the actual intervention period, which lasts for 4 months. We have called this 4-month program FUEL (Food and nUtrition for Endurance athletes – a Learning program). Each week you will receive an online lesson in sports nutrition (approximately 15-20 minutes duration). You can see this whenever you want at a time suitable for your schedule. Every other week, you are invited to a personal, digital counseling (approx. 30-60 min) by experienced sports nutrition counselors at the Sport Ireland Institute via Zoom. Here, you will receive guidance on how to optimize your diet, so it fits your training volume. You will also be introduced to the online training diary BESTR, where you are going to register exercise, sleep, menstruation, and well-being. Immediately after the intervention and 6 and 12 months after the intervention, you will also be asked to answer questions related to exercise, sports nutrition, menstruation, injuries, illness, motivation, and psychosocial health.
The project is a multi-center study, which takes place in Norway, Sweden, Germany, and Ireland. All parts of the study will be published in scientific journals, and it will not be possible for others to identify you in the data of the study when these are published.
Possible benefits and disadvantages
The predictable benefits of participating in this study include increased knowledge about sports nutrition, own health, and athletic performance. You will gain useful knowledge and tools to optimize your diet to suit your training. This is expected to be beneficial for your health and your performance in both the short and long term. Participation in the project is free of charge. The study is not expected to involve any side effects or disadvantages other than the time you have to set aside for participation.
Voluntary participation and possibility to withdraw at any moment.
It is voluntary to participate in the project. If you wish to take part in this research, answer the questionnaire for the project (part 1), which indicates that you automatically consent to your participation. You can withdraw your consent at any time and without giving any reason. If you withdraw from the project, you can demand that the collected samples and information be deleted, unless the data has already been included in analyzes or used in scientific publications. If you later want to withdraw or have questions about the project, please contact Dr. Sharon Madigan / Danielle Logue (smadigan@instituteofsport.ie / dlogue@instituteofsport.ie, +44 7771580797).
What will happen with the information about you?
The University of Agder is the institution responsible for the project. The information about you will only be used as described for the purpose of the project. You have the right to access your personal data and the right to correct any errors in the information that is registered. You also have the right to access the security measures when processing the information. All information will be processed without name or other directly recognizable information.
A code links you to your information through a list of names. It is only the project managers who have the opportunity to link your name with your data collected from questionnaires, diet and training registration. In the project, we have chosen a secure digital solution associated with the Services for Sensitive Data (TSD) for processing data collected in the project. TSD is a full set of services from data collection to analysis, processing, and storage in a secure environment. All processing takes place in a closed world that meets all legal requirements for privacy and security.
Project end is set for 31.12.2028 with the possibility of storing project information internally at the institution responsible for processing until 31.12.2033 due to documentation considerations. The information about you will be anonymized or deleted no later than five years after the end of the project (subject to possible extended storage; see separate section). If you do not meet the criteria for participation in part 2 of the study (the intervention), information from the initial questionnaires will be treated in the same way as the remaining information in the project.
Data sharing and cooperation abroad
By participating in the project, you also agree your data from tests and questionnaires can be transferred to collaborating researchers abroad (Norway, Sweden, Denmark, and Germany) as part of research collaboration and publication. The code that links you to your personally identifiable information will not be provided and the project manager will ensure that your information is safely taken care of.
Insurance
While you participate in the study, you are automatically insured since the University is covered by State insurance.
Follow-up study
By participating in this study, you also agree that we can contact you again within five years after the end of the project for a follow-up study. Extended retention period beyond this will possibly be applied for by the regional ethics committee and if the application is approved, you will be informed of this. You can of course participate in this study you are being asked for now and still refuse any future study.
Approval
The Regional Committee for Medical and Health Research Ethics and the Norwegian Center for research data in Norway have assessed the project and have given prior approval case numbers: 31640 and 968634.
Pursuant to the latest version of the Norwegian Personal Data Act, the person responsible for handling personal data at the University of Agder and the project manager Monica K. Torstveit, have an independent responsibility to ensure the legal safeguarding of your personal data. This project is based on the legal provisions of the EU’s General Data Protection Regulation Article 6a and Article 9 no. 2 and your consent. You have the right to send a complaint on the handling of your personal data to the Norwegian Data Protection Authority.
Please contact the Data Protection Officer of the University of Agder, Ina Danielsen, for any questions on the handling of your personal data in this project, or if you have a complaint with regards to the handling of your personal data.