This simple walkthrough will help you to understand the study, the impact it will have on your life, and will allow you to provide consent to participate.
Taking part in this research study is completely voluntary. There is no cost to participate, except the use of your smartphone. You will not be compensated for your time, effort, or phone usage. If you are interested in participating, you should read through this document, and sign at the informed consent screen to show that you understand the benefits and risks of the study. You will receive a copy of the signed consent form for your records. Thank you for considering myCircadianClock!
A member of our research team is available to to answer any questions you may have concerning this research study. You can contact them at the following email address: firstname.lastname@example.org
This study is sponsored by the Salk Institute. The principal investigator of the study is Dr. Satchidananda Panda.
What is Circadian Clock. Circa (= approximately) dian (= day) rhythms are daily rhythms in activity, sleep, eating pattern and behavior that helps our body to anticipate and adapt to predictable events in the environment. These rhythms are generated and maintained by biological clocks that are present in the brain and in almost every organ of our body.
Remarkably, even in the absence of any real clock or timing information from a device, our body can keep track of time and thereby helps us go to sleep and eat at optimum times. However, as we can choose to eat, exercise, and go to sleep at a time that is dictated by our lifestyle, sometimes we do these daily routines at a time of the day when our body clock has not prepared our body for it.
When these abnormal daily patterns continue for several weeks or years, it can affect our health in many ways including body weight, sleep and risk for various chronic diseases. These daily patterns are affected by where we live (such as near to the equator vs in high latitudes where winter days are very short), season, our work habit, age and many unknown factors.
By collecting data from large number of individuals of different ages, from different places and in different seasons, researchers can have an unprecedented understanding of how circadian clock affects health.
This study will ask you to perform tasks and respond to surveys.
myCircadianClock provides personalized insights into how your daily behaviors relate to quality of life, and to help you manage your general health including weight. In general, richer data entered into the app results in more accurate and informative insights.
To drive these insights, myCircadianClock will ask you to: Answer survey questions about your health behaviors, log your body weight, record what you eat or drink, and log your sleep as best as you can.
The app sends occasional reminders to complete study activities.
3- Sensor and health data
This study may gather sensor data from your phone
Learn More: myCircadianClock may use the built-in accelerometer in certain phones to passively keep track of physical activity (passive because this happens automatically and you do not need to enter any information). The app interprets accelerometer data as steps taken, or as different intensity levels of activity. The app can also detect when you use the phone to get an independent estimate of your rest or sleep period.
For these activity measures to be accurate, you should carry the smartphone on your person as much as possible (e.g., in your pocket, or clipped to your waist). For instance, if the phone is left on a desk or in your car when you go for a walk, it will not be able to detect your walking.
The app will also use the built in GPS sensor to tag the location only when you log your data. This will help you to track what and where you eat, which may help you adjust your diet. It helps the research to account for any unusual change in your eating or sleeping pattern due to a change in time zone when you travel. Change in time zones or moving to a different latitude within the same time zone can change the local sunrise and sunset time or local daylength, which can affect your circadian clock for a few days.
4- Data Gathering
Our daily pattern of activity, sleep, and eating changes with season, latitude, work schedule, and travel. Collected data may reveal how daily behaviors affect your quality of life and body weight, and also advance clinical research into Circadian Rhythm.
myCircadianClock helps you keep track of health behaviors such as diet, activity, sleep and taking your medications or supplements.
Data that you share through the app as part of the research study will create an unprecedented large scale database of daily behaviors and health provided by people just like you.
Studying all this real-world data will help researchers understand how daily behaviors influence health in real life, with a resolution never achieved before. (Traditionally, these studies are done by asking people to recall answers to very long questionnaires on paper.)
At the same time, myCircadianClock analyzes your data to provide personalized insights into how your daily eating and sleeping pattern relate to your overall health, and helps you maintain a healthy lifestyle. Since the feedback is determined from a few days of your routine behavior, some of these insights will be accessible in your phone after two weeks of data collection.
To improve data collection, the app may send you a reminder and push notification. If you do not want to be bothered with these reminders, you can turn this option off.
By combining a personal app and a research study, myCircadianClock will help explore how the smartphone may be used with new kinds of clinical research in the future.
Your data will be sent to a secure database where it will be separated from your personal identity.
We take several steps to protect your privacy and the privacy of your app data.
To certify that you consent to participate in the study, we ask you to enter your name and an email address. This allows study investigators to have a record of who participates in the study, and to email you a copy of the signed consent document.
Your name and email are only used for the consent process, and are not associated with data collected from the app.
App-generated data is associated only with a random study code, and this code is used in all future analyses separating it from any personally identifiable information.
These steps ensure that researchers analyzing the coded study data will not be able to connect it to any individual user.
Whenever app data is transferred to a research study computer, it will be encrypted so that others cannot interpret the data or associate it back to you
Encrypted app data (stripped of personal identifiers, and associated only with a random code) will be sent to secure data servers used for the myCircadianClock research study.
Study investigators chose Amazon cloud server for this important responsibility because they are a world leader in the secure storage and protection of sensitive data. They have a proven track record of safeguarding and managing potentially sensitive biomedical data in accordance with regulations that govern human research and medical information (e.g., regulations mandated by Institutional Review Boards [IRB] and the Health Information Portability and Accountability Act [HIPAA]).
We will de-identify your data and use secure computers, but we cannot ensure complete privacy
Only Dr. Satchin Panda and his Research Coordinator will know the identities of people who participate in the study.
One potential loss of privacy would be if someone sees your data from myCircadianClock on your smartphone.
For security, myCircadianClock suggests that your smartphone be protected either by a passcode or fingerprint sensor. This ensures that only you can enter and use the app.
6- Utilizing Data
Your coded data will be used for research and may be shared with other researchers.
Study investigators will analyze coded app data from everyone who agrees to participate in the myCircadianClock study, but they will be unable to connect it back to any individual user
The results of this research may be published in a scientific or medical research journal so that others can learn from this study. Results will never be published in a way that would allow data to be associated with individual users.
After this study is completed, other researchers may request access to the coded study data (already stripped of personal identifiers), so that it can be analyzed in a new way to benefit medical research. Those requesting data must agree to use the data for research responsibly and in accordance with applicable regulations; these data requests will be reviewed by a group of study investigators. Amazon Cloudserver will have no oversight over future research conducted with coded study data.
Other researchers who are granted access to coded study data will not be able to connect the data back to study participants.
Study data will never be sold to any third party.
7- Issues To Consider
Your participation in this study will take a few minutes per day on average.
Entering information and responding to surveys should take on average a few minutes each day. Occasionally, tasks may take a little longer (e.g., a longer questionnaire).
Some questions may make you uncomfortable.
Any information you provide is completely up to you. You can decline to answer survey questions or participate in the apps tasks. If a survey question makes you feel uncomfortable, you are free to leave questions blank.
Participation in this study does not require you to change anything related to your smartphone account or data plan. The app can use either an existing mobile data plan or WiFi connections; you may configure the app to use only WiFi connections if you wish to limit impact on your data usage.
If you choose to participate, this study lasts for 18 weeks. Up to 18 weeks you will receive prompts and questionnaires as part of the study. After 18 weeks, you are free to continue using the app for the personal insights if you wish. Beyond 18 weeks your usage data will be analyzed to study seasonal or long term patterns in daily circadian rhythm.
You may be randomly selected for contact by the authorized researcher via email or phone to verify your identity or clarify some of your answers to surveys. You may also be contacted in the future for study related questions. Examples include but are not limited to; if you continue to collect data beyond 18 weeks spanning different seasons, if you change your work schedule between regular and shiftwork. Long term data from individuals who can or cannot easily adjust to these time changes will help researchers understand which factors help our circadian clock to adjust to changes.
As with any smartphone app, use your common sense and follow prevailing laws about when and where you use your smartphone. Just as you would not text while driving, do not interact with the app while driving or doing any other activities which could result in injury. You can always wait until you are in a safe place to perform any app-related tasks. Similarly, follow local and federal regulations about the usage of smartphone in specific areas.
8- Study Survey
Some of the tasks in this study will require you to answer survey questions about various health and lifestyle factors.
myCircadianClock will collect some of its data on your health behaviors through short survey questions, such as:.
Did you forget to eat breakfast today?
When did you wake up this morning?
Do you feel sleepy during the day?
Occasionally, there will also be longer surveys that evaluate aspects such as your work habits, quality of life, and sleeping pattern.
For dietary information, myCircadianClock will prompt you to take pictures of every food, beverage, water, medication, and supplement(s) you take.
When picture taking is difficult or socially awkward as in a meeting, if you forgot to take picture or you are repeatedly eating the same item, you can also enter the information textually from a different screen.
In general, more data entered into the app results in more accurate and informative personalized insights.
9- Study Tasks
Some other interactions with the app are designed to maximize both data gathering and the feedback you receive.
myCircadianClock will also ask about some information that requires a brief task away from the smartphone, such as: Your weight, Your height, Your waist circumference (occasionally). The app also has optional fields to enter your blood sugar, and blood pressure if you wish to monitor these parameters
myCircadianClock provides personalized feedback in the form of graphs and text to display your progress, and provide insights into your health behaviors.
The app summarizes data about how food, sleep or activity patterns in specific time of the day are associated with your health and wellbeing. These insights may help you understand your health behaviors better, and help you manage your health. Viewing the graphs and text is optional but may be useful or interesting to you.
For the passive sensing of your physical activity in some phone models to be accurate, it is important to carry your smartphone on your person (e.g., in your pocket, or clipped to your waist). Carrying your phone will also help you log food, beverage , water and activity data as soon as these events occur.
In your Profile within myCircadianClock, you can set reminders for yourself to complete app activities. In general, more data entered in the app results in more accurate and informative insights.
You may withdraw your consent and discontinue participation at any time.
If you start the research study but later wish to drop out, simply contact the study investigators through the app. You may choose to leave the study at any time. Your decision will not result in any penalty or affect your medical care through your usual physicians or providers. Afterwards, you are free to delete the app from your smartphone.
The study investigators may also withdraw you from the study without your consent at any time for any reason, including if the study is cancelled.
11- Potential Benefits
The information collected by this study may help you better understand and monitor your health.
One of the biggest challenges for people is the difficulty of tracking their diet, activity, sleep, medication/supplements, and other health behaviors. myCircadianClock may help by streamlining these daily tracking tasks.
myCircadianClock will also provide personalized insights and feedback to help you understand how your daily behaviors can influence your health. This may help you manage your health.
More generally, the general public may ultimately benefit from this research, because myCircadianClock and its research study will create an unprecedented crowd-sourced database of daily behaviors and health parameters from people just like you.
Studying all this real-world data will help researchers better understand the relationships between circadian rhythm, diet, exercise, and sleep in real-world people. It will also help explore how the smartphone can enable new kinds of clinical research.
12- Risks and Benefits
Participating in this study may change how you feel. You may feel more tired, sad, energized, or happy.
There are possible risks, discomforts and inconveniences associated with any research study. This study does not involve testing any new drugs or therapies, so we do not expect any medical side effects from participating. The app is not designed to give medical advice, nor make suggestions related to treatment or medications.
The primary concern associated with this study is privacy risk. Please see the sections on Protecting Your Data and Risk to Privacy to learn more.
You may feel inconvenienced by having to enter information into the app, or seeing the reminders or messages that are sent by the app.
Please see the section on Potential Benefits to learn more about the potential benefits of this study.
By filling in the information below, you are acknowledging that you have read the informed consent and agree to participate in this study.