Participant Information Sheet (PIS)

Intervention study of the impact of using the Jonple Ltd. application (app) to support dietary change

Principal Investigator: Ms. Swyn Cadifor Ifans, School of Biomedical, Nutritional and Sport Sciences, Newcastle University

Supervisor(s): Ms. Susan Lennie & Dr. Anthony Watson, School of Biomedical, Nutritional and Sport Sciences, Newcastle University

Collaborations: Ms. Emma Kellett, Jonple Ltd.

Invitation

You are being invited to take part in a research study which is being conducted by a Newcastle University final year student studying Food and Human Nutrition at the School of Biomedical, Nutritional and Sport sciences. Prior to your decision, it is crucial that you understand the reasons as to why the research is being carried out and what it will entail. Please read the following information carefully; feel free to discuss it with others if you need. Feel free to ask us any questions if you feel that you require more information or if something is not clear. Take your time deciding if you wish to take part in this study or not.

Study overview

The main purpose of this research study is to measure the impact of a health and nutrition app, Jonple Ltd., in supporting weight loss.

For our research we are seeking adults over the age of 18 years to participate in a 4-week intervention study. To qualify for participation in the study you must have a BMI of over 25kg/m². You will complete a consent form and a participant health questionnaire regarding any dietary requirements and any health conditions that may impact on your involvement in the study prior to the start of the 4-week study.

What is involved? 

Participants will be asked to follow a diet plan as recommended by a commercially available health and nutrition app.  In advance of this, participants will have a one-to-one consultation with the researcher to gather body measurements (weight, height, girths of upper arm, lower leg (calf), waist and hip) and information on current dietary habits through a food diary where you record all intake over 2 weekdays and 1 weekend day.

These measurements will be taken at the start and the end of the study and you will be given guidance on how to complete these.

The consultations will last approx. 30mins - 1 hour and will also be an opportunity to ask any questions you might have. The consultation will be private and will not involve any other participants. You will need to have access to a flexible tape measure for the measurements. In preparation for the consultations, we ask that you wear a short-sleeved sports top and either leggings or loose-fitting shorts. These measurements should not cause you any harm or discomfort, and there are no risks associated with these methods.

Participants will use the food section only, or the health and nutrition app on a regular basis over the 4 weeks.  Access will be free, through provision of a code to apply once you have downloaded the app.  You will receive your individual code during the initial online consultation.

At the end of each week, participants will be required to answer a brief poll exploring how closely the diet plan was followed in the previous week and if they feel they can continue. The survey will take approximately 2 minutes to complete.

Following the initial online meeting, you will use the nutrition component of the app freely (please do not use the fitness section), and you will only meet with the researcher at the end of the 4-week period for the final measurements.

What will happen to my data?

The data collected across this intervention will be analysed and used to determine whether the dietary programme of the Jonple app supports successful weight loss. Your data will not be stored against your name, you will instead be given a participant identification number, which will be used in replacement of your name across any electronic storage of the data prior to publication. Your data will be presented in aggregate, and therefore individual sets of data will not be identifiable.

Risks and discomforts

To overcome any risks with changing to new dietary habits, the medical questionnaire needs to be completed. This will assess if a change in diet could harm the participant. If at any time during the study, you fall ill as a result of dietary change then you can terminate your involvement in the study for your own health. To overcome any risks involved with cooking e.g. raw meats, fire risk and knives, you must follow basic kitchen safety protocols and practice basic food hygiene. The online sessions will be one-on-one, meaning that participants will be unaware of each other’s identity or information. Each participant will be numbered, meaning that during data analysis your confidentiality and anonymity will be maintained.

Benefit

At the present time, there are no known benefits of using the Jonple app. However, by taking part in the study you will be assisting us in understanding whether the app supports weight loss. Furthermore, the data will be used to improve the digital app, which is widely available to the general public, increasing their knowledge and understanding of the correct health and lifestyle choices. It may also support weight loss and improved fitness habits.

Reimbursement

As a thank you for taking part in the study, you access to the Jonple app will continue for a full 12 months.  Beyond the study, you will be free to use all components of the Jonple app, rather than just the nutrition section.

Confidentiality

Your individual privacy will be maintained in any and all publications or presentations that result from this research. This will be done by assigning you a unique identification number which will be used instead of personal details for electronic storage of the data. Your name or personal details will not be written on any paper copies of data collection and will never be disclosed in any research documents which are included in the study. All online sessions will not be recorded, and no images will be taken at any time during these sessions. All information that you provide will be kept strictly confidential and anonymised.

University and organisations overseeing research governance may look at your study records. A study number, as opposed to your name, will be used on all records, so you will not be identifiable should this occur.

 Voluntary Participation and the Right to Withdraw

You have the right to withdraw at any time throughout the study if you feel at any point that you may not wish to continue, without penalty. If you do withdraw from the studies, you may request that your research data and information be removed. This can be done by contacting the Principal Investigator’s listed above and below.

 Contact information

If you have any questions regarding the study or your involvement in it please contact Swyn Ifans (PI) via email (s.ifans@newcastle.ac.uk)

If you have any concerns or complaints about the research, please contact the research project supervisor Susan Lennie via email (susan.lennie@newcastle.ac.uk)

Thank you for taking the time to read this information sheet.

If you wish to take part, please click here: https://forms.ncl.ac.uk/view.php?id=9922904