RESEARCH KEY INFORMATION

You are being asked for your permission (consent) to take part in a research study. This section provides a summary. It describes key information to help you decide if you want to take part. Later sections of this document will provide more details you need to know. 

Throughout this Key Information section, “we” means Evidation and anyone authorized to act on Evidation’s behalf. Note this document (including this section) is for informational purposes only, and is not legal advice.

Do I have to participate in this research?

No. Your participation is voluntary (optional). You can decide to take part now and drop out later. If you choose to not participate or if you drop out later, you will not experience any penalty or loss of benefits to which you are otherwise entitled.

Why is this research being done?

The purpose of this research is to better understand health outcomes related to weight-management behaviors. We’re asking you to participate in this research because you told us about your previous experiences related to weight management.

What will I be asked to do if I agree to take part in this research?

If you decide to take part in this research study, you will be asked questions about your weight, experiences with weight management treatments, and your perceptions of potential new research programs related to weight management. You will also be asked to authorize Evidation to collect and use your Electronic Health Record (EHR) using our service provider, 1UpHealth, and complete a one-time survey about your weight, weight management treatment experience, and perceptions of new research programs.

This may include giving us information that can identify you, such as your name, contact information, and information about your health. Details about the confidentiality of this information are in the “How will Study Data be kept safe?” section of this document.

Could taking part in this research hurt me? 

You can expect to experience no greater risk of harm or discomfort in this study than the risk you would in your daily life. A complete list of risks you may reasonably expect to experience is in the section “What are the potential risks and benefits of this study?” in this document.

Will taking part in this research benefit me?

It is not expected that you will directly benefit from this research. However, the results may help the investigators learn more about weight management treatments and health outcomes.

What other choices do I have besides taking part in this research?

Your alternative is to not take part in this research study. 

What else should I know about this research?

You may receive up to a total of 10,003 points for completing all study activities. More information is in the “Will I be paid for participating?” section of this document.

DETAILED RESEARCH CONSENT

We want to make sure that you understand the study and what you will be asked to do if you decide to participate. The purpose of this form is to help you decide if you want to be in this study. Please review carefully. You must electronically sign this document to participate. 

Throughout this Detailed Research Consent section, “we” means Evidation and anyone authorized to act on Evidation’s behalf. 

What do I need to know?

Taking part in this study is voluntary (optional). You can choose not to take part in the study. You can also agree to participate in this study and change your mind later. If you choose to not participate or if you drop out later, you will not experience any penalty or loss of benefits to which you are otherwise entitled. This is not a medical treatment study. The alternative to taking part in this study is to choose not to take part in this study.

Why is this study being done?

This study’s main goal is to better understand health outcomes related to weight-management behaviors. This includes the use of medications and lifestyle changes. We’re asking you to participate in this research because you’ve told us about your previous experiences related to weight management. 

How many people will take part in this study?

Around 500 people will take part in this study. 

Who is funding this study?

Evidation Health (also called “Evidation”) is sponsoring this study. Evidation is running this study on its “Evidation Studies” platform, which is available online (through a web browser) and on mobile (through an app on your phone). 

What will I be asked to do if I participate in this study?

If you choose to participate in this study, Evidation will ask you questions about your weight,  experiences with weight management treatments, and your perceptions of potential new research programs related to weight management. 

Additionally, during this study, Evidation will ask you to:

• Authorize Evidation to access, use, and disclose your Electronic Health Record (EHR) as described in this document.
• Connect your EHR using a service provider, 1UpHealth.
• Complete a one-time survey about your weight, weight management treatment experience, and perceptions of new research programs.

Please review the  list below. This list will give you information about what taking part in the study will look like for you.

1. Authorize Evidation to access, use, and disclose your Electronic Health Record
   1. Description: Electronically sign the Electronic Health Record Authorization Form
   2. When will this happen: Immediately following your completion of this consent form
   3. How long will it take: Around 5 minutes 
2. Connect your EHR
   1. Description: Authorize 1UpHealth to access and disclose your EHR to Evidation for the purposes of this study
   2. When will this happen: Immediately following your completion of the Electronic Health Record Authorization Form
   3. How long will it take: Around 5 minutes 
3. Complete a one-time survey 
   1. Description: Complete a brief survey about your weight, weight management treatment experiences, and perceptions of potential new research programs
   2. When will this happen: Immediately following your completion of the EHR connection
   3. How long will it take: Around 15 minutes 

Evidation will keep track of whether you are completing the study-related tasks described above (for example, connecting your EHR). Depending on your communications preferences, you may be contacted by email, text message, push notification, and/or phone call with reminders to complete study activities. 

The tasks described above may include giving us information that can identify you, such as information contained in your EHR. Details about the confidentiality of this information are in the “How will Study Data be kept safe?” section of this document.

How long will I be in this research study?

This study consists of authorizing Evidation to access, use, and disclose your Electronic Health Record and completing a one-time survey. We will let you know when the survey becomes available, and then you will have approximately 7 days to complete it. You will be finished with the study when you authorize Evidation to access, use, and disclose your Electronic Health Record and complete the survey.

How long will you collect information about me for this study?

If you choose to participate in this study, we will ask you to do the tasks described in the “What will I be asked to do if I participate in this study?” section above. These tasks may include giving us information that can identify you. Additionally, if you choose to participate in this study, we may need to confirm you are still eligible (qualified) to participate. To do this, we may collect information to confirm your identity and other facts about you (for example, your age or the area you reside in). 

After you are officially enrolled (participating) in this study, we may begin collecting information about you to help complete this study (also called “Study Data”). The specific types of Study Data we may collect are listed in the next section of this document. 

Study Data collection starts on the date you are accepted into the study, and will continue up to a maximum period of 7 days or until you complete the study activities listed in the "What will I be asked to do if I participate in this study?" section above, whichever date is later. We may stop collection for various reasons, for example, if you:

• complete all the study tasks,
• become ineligible (disqualified) for the study, 
• withdraw (drop out) from the study, or 
• the study ends.

We will also collect historic activity data, such as data from Fitbit, Apple Watch, and other devices, which may include information about your steps, sleep, heart rate, and other data captured by your connected wearable device from the past 2 years, measured from the date you are accepted into the study. Providing this information is required for participation in this study. If you do not want to provide this information, you can choose to not take part in this study. For more information about the Study Data collected as part of this study, please see the “What information will you collect about me?” section of this document.  

Study Data collected as part of this study may be stored and maintained indefinitely for research purposes, in accordance with applicable laws and regulations. However, your identifiable information will be handled as described in the "How will Study Data be kept safe?” section of this document.

What information will you collect about me?

If you consent to take part in the study we will collect your email address to verify your identity. We will also use data associated with your Evidation account such as age, sex, race, ethnicity, current medications, medical diagnoses and whether or not you have connected wearables to your Evidation account to determine your eligibility for this study. 

After you are officially enrolled (participating) in this study, we may collect the following types of Study Data:

• Name and contact information, for example: 
  • Name
  • Postal (mailing) address
  • Email and phone number

• Information from questionnaires and surveys you answer as part of this study, for example:
  • Demographic information, such as age, gender, marital status, income, employment status, education level, and similar demographic details
  • Self-reported information (information according to you, not someone else like your healthcare provider), such as your weight, medical history, and experience with weight management treatments
  • Self-reported perceptions of new research programs
  • Emails or other communications you send to us 

• Past activity data from your connected wearable devices (such as a Fitbit or Apple Watch) for the 2 years prior to officially enrolling in the study, where available:
  • Number of steps you take in a day
  • Sleep performance, such as how long you sleep, how deeply you sleep, and the overall quality of your sleep
  • Heart rate data, such as average heart rate and variability 

• Identifiers and device information, for example:
  • Internet Protocol (IP) address
  • Device identifiers, operating system, browser type 
  • Other system settings, such as language, time zone, and configuration 
  • Information from “cookies” and similar technologies, which we use solely for drop-off analysis (keeping track of when you exit out of a survey, questionnaire, or other window without finishing the task, so we can improve future surveys and tasks by making them more engaging)
  • Usage data for the “Evidation Studies” platform, such as pages you viewed and how long you spent on a page

• Other data collected from you as part of this study, including:
  • Information in your Electronic Health Record, subject to your authorization. The information in an Electronic Health Record may vary, but may include data such as: 
    • Care plans
    • Vital signs
    • Lab test results
    • Diagnoses, diseases, and conditions
    • Allergies and intolerances
    • Medications and treatments
    • Procedures and surgeries
    • Prescription medications
    • Social and behavioral health information
    • Mental health and cognitive assessments
    • Clinical notes and interpretations

We also infer new information from other Study Data we collect, including using automated means to generate information about your likely preferences or other characteristics (“inferences”). For example, we may infer information about the weather or environmental conditions you may experience based on your postal address or IP address. 

We will not provide your doctor with your results from any study tasks without your separate consent. Neither you nor your doctor will receive the results from any study tasks.

The Study Data we collect depends on the information you provide us and the choices you make. For example:

• If you do not answer optional questions in a survey or questionnaire, we will only collect your responses to the questions that you do answer. 
• If you do not have one of the wearables that you can connect to Evidation (such as an Apple Watch), we will not collect that information from that wearable (but we may collect information from wearables that you have connected to Evidation).

How will Study Data be used?

Evidation will use Study Data to explore the relationship between weight management behaviors and health outcomes. Evidation will also use Study Data in combination with information associated with your Evidation account, for example, data about demographics, survey responses about your experiences related to diagnosed health conditions, survey responses about your weight management experiences, survey responses about social determinants of health, information from daily check-ins you complete, and data from your connected wearables.

Study Data will also be used as needed to administer the study in other ways, such as communicating with you about study tasks. More information about who may access Study Data is in the “Who will have access to Study Data?” section of this document. 

We may use quotations from study tasks, such as any questionnaires and interviews, in publications and presentations, but we will not attribute the quotations to you. Evidation may also use Study Data to identify future research or demographics, social determinants of health, health conditions, daily check-ins, and other data associated with your Evidation account to identify other opportunities for which you may qualify. Taking part in such future research is voluntary and may require you to sign a new consent form. Coded Study Data (described in the next section) may also be used for the following research purposes: 

• Research related to this study, 
• To advance other research, and
• To design future studies.

You may not be informed about the specific research studies that may be conducted using your information, including the purpose of those studies. Some of these studies may be research projects you might have chosen not to consent to if asked separately.

How will Study Data be kept safe?

Evidation takes reasonable and appropriate steps to keep Study Data confidential and protect it from unauthorized access, use, disclosure, alteration, and destruction. In general, before disclosing Study Data to persons not affiliated with Evidation, we will remove directly identifying information (such as your name and email address). We then replace that data with a randomly generated sequence of numbers and letters (for example, 18903fhsi564afs), so it becomes “Coded Study Data.” This helps us minimize the overall amount of information that we share with others while still achieving the purpose of this study. We will only use Coded Study Data for analysis in this study. Only authorized personnel can view uncoded Study Data. 

In limited situations, we may need to provide other persons with directly identifying information, so that they can communicate with you or help us pay you for your participation in this study. Study Data and Coded Study Data will be stored securely on limited access, encrypted servers maintained by Evidation Health and external research partners. 

We will only publicly share results from this study using a summary of Coded Study Data from all participants. We will never include directly identifying information, such as your name, in public results from this study. 

Who will have access to Study Data?

If you choose to participate in this study, we may make uncoded Study Data and Coded Study Data available to specific third parties. 

Uncoded Study Data will only be accessible by a limited number of authorized Evidation personnel and select Evidation vendors (listed below). They may use the information to contact you if they have questions about Study Data we collected from you. Additionally, regulatory authorities like the Department of Health and Human Services (HHS) or the Food and Drug Administration (FDA), as well as the Institutional Review Board (IRB) for this study, may review uncoded Study Data as part of their oversight activities. This means that absolute confidentiality cannot be guaranteed.

• Vendor: 1UpHealth
• Type of uncoded Study Data: Electronic Health Records
• Purpose: To facilitate Evidation’s access to your Electronic Health Record, subject to your authorization. You can contact them using the information on this webpage: https://1up.health/about-us/contact/

The following persons may have access to Coded Study Data or a summary of Coded Study Data: 

• Evidation personnel, who help administer this study. 
• Evidation may then share summary or coded study results with Evidation’s research partners, employees and representatives (including affiliated companies), vendors, and other third parties.
• External research partners, who help administer this study and prepare the results of this research for publication. 
• Scientific publications, who verify the quality of the research and help prepare the results for publication. 
• Other third parties, for the third parties’ purposes; in this case, Evidation will contractually prohibit each third party from re-identifying, attempting to re-identify Coded Study Data, and Evidation will contractually require each third party to store Coded Study Data securely on limited access, encrypted servers. Evidation will also contractually require each third party to require any downstream recipients of Coded Study Data to agree to the same prohibitions and requirements.

Summary study results may be provided to persons that are located outside of the U.S. 

Once your health data has been shared with authorized users, it may no longer be protected by federal privacy law and could possibly be used or disclosed in ways other than those listed here.

Will I be paid for participating?

Yes, you will receive up to a total of 10,003 Evidation points for completing all study activities. You will only earn payment if you are eligible to enroll in this study, you officially enroll in this study, and you follow the study procedures. You may not receive payment if you are removed from the study without your consent, such as when Evidation has reason to believe your completion of the study procedures is suspicious.

10,000 Evidation Points can be exchanged for $10. Evidation points are further described in Evidation’s Terms of Use. 

The list below outlines the payment timeline:

1. First payment: 3 points. You may expect this payment once you have electronically signed this informed consent and the Electronic Health Records Authorization Form. 
2. Second payment: 8,000 points. You may expect this payment once you have authorized 1UpHealth to access and disclose your EHR to Evidation. You will be able to complete these two tasks after signing this informed consent and the Electronic Health Records Authorization form. 
3. Third payment: 2,000 points. You may expect this payment once you have completed the one-time study survey. You will be able to complete this task after connecting your EHR. 

Payment

Evidation staff will send your first payment within 1 day after electronically signing this informed consent form and the Electronic Health Records Authorization Form. Evidation staff will send your second payment within 1 day after authorizing 1UpHealth to access and disclose your EHR to Evidation. Evidation staff will send your final payment within 1 day after completing the one-time study survey. 

You must finish all enrollment steps within 7 days of signing this informed consent form and the Electronic Health Record Authorization Form. If the study fills before you finish the enrollment steps, there is a chance you might not be able to take part in the study. 

Evidation will provide payment for the study activities you complete as instructed. We will not pay you for study activities completed late or left incomplete. If you decide to withdraw from the study, you will receive the payment you earned before withdrawing.

You will receive payment electronically through the Evidation app. 

The research that takes place during this study may lead to new tests, technologies, or other commercial products. Evidation may receive additional payment for analyzing the study data or doing other research. You will only receive the payment described in this document. No other financial payment or benefits are being offered to you.

There will be no charge to you for your participation in this study.

What are the potential risks and benefits of this study? 

This is a study that involves collection of Electronic Health Records. 

Your Electronic Health Record includes sensitive information about your health. Your privacy is very important to us. Evidation will take reasonable and appropriate steps to keep Study Data confidential and protect it from unauthorized access, use, disclosure, alteration, and destruction, as further described in the “How will Study Data be kept safe?” section of this document. For example, we use “coding” to mitigate (lessen) the privacy risks of using Study Data, as described in the “How will Study Data be used?” and “Who will have access to Study Data?” sections of this document. As with any study involving information about you, there is a potential risk of loss of privacy associated with participating in the study. Because this study involves information from your Electronic Health Record, the potential consequences of loss of privacy may be relatively greater than with studies that do not involve sensitive information about your health. Potential consequences may include emotional distress, stigma, or other risks that are unknown. 

If there is reason to believe that the privacy of Study Data has been compromised, we will contact you as required by law.

Additionally, you may have access to Study Data on a personal device (such as your mobile phone or laptop) as part of this study. The confidentiality of information kept on a personal device is always at risk for being compromised in several ways, such as when the device is shared with others, lost or stolen, hacked, or subject to a search warrant. 

You will not receive any medical treatment as part of this study. This study does not replace the care you currently receive from your doctor. You should seek care from your doctor with any health concerns. 

It is not expected that you will directly benefit from this research, but the results may help the investigators learn more about weight management treatments and health outcomes. You may choose to leave this study at any time.

Can I be removed from the study without my consent?

Evidation may stop your participation at any time. This may happen for the following reasons:

• If it appears to be medically harmful to you;
• If you do not follow directions;
• If it is discovered that you do not meet the study requirements;
• If suspicious activity or abuse is identified;
• If the study is canceled; or 
• For administrative reasons such as,
  • Enough people have already enrolled in the study or
  • The enrollment period ended.

What if I have questions or want to stop taking part in the study?

You can ask questions about this consent form or this study at any time. Evidation is here to help. Once you are enrolled in this study you can withdraw from the study at any time. 

If you decide to withdraw from this study, Study Data collection will end within approximately 3 business days from the date that you withdraw. However, any Study Data already collected will continue to be used as described above. You may also still receive automated study messages unless you withdraw from notifications using your Evidation profile. 

If you want to withdraw from study

You may withdraw from the study by navigating to your Evidation profile, choosing “programs”, selecting this study (BODEE-Weight), and choosing “unenroll”. You may also withdraw from the study by viewing your signed informed consent form and choosing the “Withdraw consent” option. 

If you choose to delete your Evidation account during your participation in this study, we will treat your account deletion as a request to withdraw from the study. 

Who to contact about study related questions:

For any questions about the study, concerns, or complaints, contact the Evidation Study Team at help@evidation.com or (650) 897-5968 (24 hr) or the study staff listed below. The email address will be available and monitored for 6 months after study completion.

Whom to contact about this study

During the study, if you experience any medical problems, suffer a research-related injury, or have questions, concerns or complaints about the study such as:

• Whom to contact in the case of a research-related injury or illness;
• Payment or compensation for being in the study, if any;
• Your responsibilities as a research participant;
• Eligibility to participate in the study;
• The Investigator’s or study site’s decision to withdraw you from participation;
• Results of tests and/or procedures;

Please contact the Investigator at the telephone number listed on the first page of this consent document. 

If you seek emergency care, or hospitalization is required, alert the treating physician that you are participating in this research study. 

An institutional review board (IRB) is an independent committee established to help protect the rights of research participants. If you have any questions about your rights as a research participant, contact: 

• By mail:

Study Subject Adviser

Advarra IRB

6100 Merriweather Drive, Suite 600

Columbia, MD 21044

• or call toll free:    877-992-4724
• or by email:          adviser@advarra.com

Please reference the following number when contacting the Study Subject Adviser: Pro00085615.

• I have read all of these study materials. I understand the consent form. I fully understand the contents of this research study as it relates to my participation.
• By completing the fields below, I give my consent to take part in this research study. I also consent to receiving standard email communication, texts, phone calls, and push notifications from the research team. Standard text message rates apply.
• I give my consent to take part in this research study, which means Study Data about me will be collected and used as described above.
• I certify that I am completing this consent on my own behalf and that my electronic signature, as documented by completing the fields below, is a true and binding legal equivalent of my handwritten signature on this consent form.