Summary Information to Help you Decide Whether to Join this Study

Study Title	Mindbody Product Order Test
Study Author	Mindbody Researcher
Principal Investigator	Matthew Amsden, CEO Efforia. Dr. Viral Patel Sub-Investigator for Adverse Events
Sponsor	This study is made possible by your payment to join.
Cost of Products, Services & Information to Participant	$100
Included Products & Services	Polar Heart Rate Monitor, Six Week Bootcamp, $100 Gift Card, Bosu Balance Trainer
Outcome Measures
Contact	help@efforia.com

Introduction & Summary

Welcome! We invite you to join this research study on the "Efforia" platform, made possible by your support. Efforia is a registered Delaware B Corporation, which means we consider public good in our business decisions alongside traditional financial considerations.

This document provides key information to help you understand the reasons for participating in this study. The study's purpose is explained, and your participation is entirely voluntary. You can leave the study at any time without penalty, and you may continue to use the products and services even if you exit early. For refunds, please contact us at help@efforia.com.

If you have questions, we encourage you to reach out to us, research independently, or consult with your healthcare provider.

Efforia is a citizen science platform where studies are effectively sponsored by you, the participants. Unlike traditional research studies, you pay for all the supplies, services, information, and tools needed for participation in one transaction. This makes studies possible that might not be otherwise.

Although you could buy these products and services separately for a similar cost, Efforia bundles them into one purchase for convenience. Efforia organizes these items and provides instructions to create a comprehensive, data-driven research experience. This setup allows you to track and understand the impact on your own life via detailed outcome reports, making informed personal health decisions easier. It also advances broader research findings, benefiting others who might not afford such purchases without guaranteed results.

Efforia is committed to equitable inclusion. If the cost is too high for you, click the large Efforia logo at the top of the screen to explore other protocols. Efforia offers protocols on various topics at different price points, including free options, so you can find one that suits your goals and budget.

Purpose of the Study

This study aims to evaluate the effects of a new treatment regime on mental and physical well-being. We will use a Polar Heart Rate Monitor to track cardiovascular activity, conduct a Six Week Bootcamp for physical fitness, provide a $100 Gift Card for personal use, and use a Bosu Balance Trainer to enhance balance and coordination. Our goal is to contribute to scientific knowledge and societal benefits by understanding how these products and services affect overall health and wellness.

What You Will Do as Part of this Study

While participating in this research study, you will need to:

• Be willing and able to follow the study directions and procedures
• Tell Efforia about any side effects or problems by communicating with help@efforia.com or online chat.
• Ask questions as you think of them, via help@efforia.com or online chat.
• Inform Efforia if you change your mind about staying in the study. You may leave the study at any time by communicating with help@efforia.com or chat.

Once you have completed enrollment, payment, entering your personal details, shipping details, and communication preferences, you will be involved in the study:

Participants are required to engage in a structured study designed to evaluate the effects of a new treatment regime. The study schedule is meticulously outlined to ensure accurate data collection and involves several key responsibilities and tasks.

The overall timeline of the study spans a period of six months, during which participants will undergo treatment activities on a weekly basis. Each session is scheduled to last approximately one hour, and it is crucial for participants to adhere strictly to this schedule to maintain the integrity of the study results.

The treatment activities involve a series of mind-body exercises, which participants must perform under guided instruction. These exercises are designed to enhance mental and physical well-being and will be monitored by the study coordinators to ensure proper execution.

Data collection will occur at the end of each session, where participants will be required to complete a questionnaire assessing their progress and any changes in their condition. Additionally, comprehensive measurements will be taken at the beginning and end of the study to evaluate the overall effectiveness of the treatment.

Adhering to the timeline and participating consistently in the scheduled activities is critical for the success of the study. Participants' commitment to following the outlined procedures will contribute significantly to the validity and reliability of the research findings.

The Risks, Discomforts & Benefits of Being in this Study

There are some unique risks, discomforts, and potential benefits of being in this study that you should understand.

Consider your Own Risk-Benefit Comfort Level

We encourage you to thoroughly weigh the risks and benefits of participation. We are placing more responsibility on you to make the right choice than in a traditionally sponsored trial. Since this is an experimental exercise, there may be possible unknown side effects that the authors are unaware of. Participants have the responsibility to consult with their healthcare providers and conduct further research at sources they find reputable before enrolling in the study.

Personal and Overall Findings

Efforia will provide you with both personal outcomes as well as overall findings. These findings will be made available at various data collection points in your experience in the study or as they are discovered by Efforia. The results and findings may impact your interest and willingness to be involved in the study. Remember, participation is voluntary, and you may exit at any time with an e-mail to help@efforia.com.

Possible Benefits of Participation

The potential benefits of participating in this study include gaining insights into your mental and physical well-being, improving your fitness levels, and contributing to broader scientific research that may benefit society. However, there is a possibility that there will be no measurable benefit to you, other than seeing reports that the intervention or treatment had no measurable impact.

Possible Serious Adverse Events & Side Effects

Introduction and Summary of Known Risks

The following products are being evaluated: Polar Heart Rate Monitor, Six Week Bootcamp, $100 Gift Card, and Bosu Balance Trainer. These products vary significantly in their nature and use, which leads to varied safety profiles and potential risks associated with each. The following is a summary of known risks. However, research is limited, and there may be risks not covered by this document, risks that are currently unknown or unforeseen. Please consider these risks carefully, do your own research, and talk to a professional who knows you well and has expertise in this area, like your personal physician.

In the Case of an Adverse Event

If you experience a severe adverse event while using any of these products, immediately seek medical attention by calling 911 or your local emergency number. After addressing any acute situations, please contact Efforia to report the incident. This will help improve the safety monitoring of these products and assist in better understanding their risk profiles.

Serious Adverse Events (SAEs)

Below is a table summarizing the potential serious adverse events associated with these products:

Theoretical side effects	Relative incidence	Recovery
Exacerbation of pre-existing injuries	Low likelihood	Improvement upon discontinuation or modification of activity
Muscle strain or injury	Moderate likelihood	Generally subsides with rest and appropriate medical care
Joint stress or injuries (e.g., knee, ankle)	Moderate likelihood	May improve with physical therapy and cessation of activity
Cardiac events due to intense physical exertion	Very low likelihood	Dependent on severity and timely medical intervention

Other Risks

Other less serious but notable risks associated with the use of these products may include:

• Frustration and irritation: Some users may experience discomfort, frustration and irritation with the technology that Efforia users to conduct studies, with the thoughts and feelings by answering probing questions and/or waiting for test results, and with a lack of progress towards reaching health goals.
• Gastrointestinal Symptoms: Uncommon but possible during intense physical activity, usually subsiding post-activity.
• Headaches and Dizziness: Can occur due to overexertion or dehydration during workouts, generally resolves after rest and hydration.
• Mood Changes and Fatigue: Possible during and after intense physical activity, typically improving with rest and adequate nutrition.

Efforia's Limitations in Providing Direct Medical Support

Efforia does not provide direct medical services or emergency medical support. Users are advised to consult their healthcare provider for medical advice tailored to their individual health needs.

Legality for Use

The use of these products should be compliant with local regulations and guidelines. Organizations such as the World Anti-Doping Association and National Collegiate Athletic Association have specific regulations that may restrict the use of certain training equipment or methodologies in official sports contexts. Employers may also have policies about the use of certain fitness programs or equipment at the workplace.

In conclusion, while these products generally present low to moderate risks, understanding and mitigating these risks through proper use and consultation with healthcare professionals is crucial for safe usage.

Inappropriate Participants Inclusion/Exclusion

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Privacy & Security Risks

We are doing everything we can think of to keep your data private and confidential. However, there is no such thing as no risk. Potential participants should review the Efforia general privacy policy, which is available here: https://efforia.com/privacy-policy/

There may be very certain limits to the rights of your privacy:

• We may reach out to local help if we have reason to believe you may be a harm to yourself and/or others.
• Regulators, like the FDA or similar agency, or Institutional Review boards may review records that have your identifying information.

What to do if you have a study related injury

If you experience any problems, side effects, or a study-related injury, seek local medical care first, if necessary. Efforia cannot provide emergency medical care or diagnosis. However, it is important to contact Efforia after receiving any necessary treatment. We want to ensure others are aware of potential risks.

Study related injury care and compensation

Efforia is not able to offer financial compensation nor to absorb the costs of medical treatment should you be injured as a result of participating in this research. Efforia makes no commitment to provide free medical care or payment for any unfavorable outcomes resulting from participation in this research.

In the case of medical emergency

In the case of medical emergency please dial 911 immediately. Do not attempt to contact Efforia until after the emergency has passed. Access local in person medical assistance immediately. If at any time you feel like you may be a danger to yourself or others, please dial 988 for the National Suicide Prevention hotline. Help is available.

Alternatives to Participating in the Study

This study is for research only, and the only other choice would be not to be in the study. If this study does not seem quite right or too expensive for your specific purposes, Efforia is dedicated to making other studies available. You may click on the Efforia logo in the upper portion of the page and find a different study that may be more appropriate.

Your Rights as a Participant

Efforia upholds the same high ethical standards in research as seen in pharmaceutical and academic studies, despite only hosting and not sponsoring or conducting these studies. Your participation in this study is completely voluntary, and you are free to withdraw at any time without any adverse consequences. You are not giving up any rights by signing this document.

Efforia may remove you from the study if you have violated Efforia's overall terms and conditions, privacy policy, or have a conflict of interest. Efforia may also remove you from the study in the interest of safety based on individual or community findings.

Privacy and Confidentiality

You have a right to privacy and confidentiality in this research effort. Your personal information is protected through robust measures ensuring anonymity or confidentiality. All data processing is designed to safeguard personal data against unauthorized access and misuse.

Right to Your Own Results

Participants have the right to a complete explanation of the research once their involvement concludes, particularly if the study involves any form of deception like placebos or controls.

The Right to Leave a Study without Penalty at Any time

If you decide to withdraw from the study, you can do so at any time by visiting your Profile page, selecting "Your Protocols," and clicking "Leave." Upon leaving, you will be refunded for any consumable products that have not yet been shipped. For non-consumable products, a full refund will be issued upon their return in accordance with our return policy. This ensures that you can participate in the study with the assurance that your financial contributions are handled fairly and with respect for your consumer rights.

Conflict of Interest Statement

As part of our commitment to ethical conduct and transparency in our citizen science clinical trial, it is essential to disclose the unique structure of our study. This clinical trial is hosted by Efforia, but it is uniquely sponsored by you, the participants. Efforia serves solely as the platform provider and does not sponsor or influence the study outcomes.

Efforia takes a transaction fee on all the products and services included in this protocol. Otherwise, we have no financial interest or conflicts of interest. To further reduce conflicts of interest, we will remind you once if you do not complete enrollment in this study. We will not remarket to you, nor otherwise push you to join the study.

How we Reduce Conflicts of Interest

You have a role in reducing conflicts of interest as well. It is crucial that participants do not have any financial relationship with the intervention methods or measurement providers used in the trial, nor should they be employees, investors, stakeholders, or protocol authors associated with these entities. Participation under such conflicts of interest could significantly compromise the study's integrity and the validity of its results.

Consequences of Conflict of Interest Non-Compliance

Should you fail to disclose such a conflict of interest or if a breach of this policy is discovered, you will be subject to immediate suspension from this platform and payments may not be refunded.

By joining this trial, you affirm that you understand the above conflict of interest restrictions and agree to comply fully with them. Your participation is valued, and your adherence to these guidelines ensures the validity and reliability of our collective scientific efforts.

Data Protections

We will collect, use, and protect your data in compliance with data protection laws. You own your own data, and it will be housed on Efforia indefinitely until you tell us to delete it by e-mailing help@efforia.com.

What you can do to improve your privacy and security

As part of participating in this study, you will receive notifications via e-mail, SMS, or push notification when new study tasks like questionnaires and reminders are ready for you. You can adjust your communication preferences in the Efforia application at any time. If you do not want to receive notifications from this study, do not press the Accept button. You can decide not to join this study, and will not receive notifications. To ensure others don’t see these alerts, you should make sure your phone or desktop computer and your e-mail accounts are protected by a password, pin, or other form of “access control.” You should also avoid sharing your accounts with others or sharing your account passwords. As this study is hosted in Efforia, it is governed by a set of privacy and confidentiality standards that put you, as a participant, in control. You can learn more about Your Privacy and Security rights on Efforia here: https://efforia.com/privacy-policy.

Who will have access to your data?

Efforia will have access to your data. There may be partners who also have access to your data, such as labs and connected health devices.

What will we do with your data

We will use the data to show you your own personal results and pool your results with other participants to provide general outcomes. We will not use your information connected with your name or anything that connects the data with you without your permission.

Authorization to Use and Disclose Protected Health Information

If you decide to take part in this study, the study doctor and study staff may use and share protected health information (PHI) about you to conduct the study. Protected health information may come from your medical or research records. Protected health information may include the following:

• Name
• Location
• Dates
• Phone Numbers
• Email Addresses
• Internet protocol (IP) address numbers

The study staff may share protected health information about you with the following authorized users to ensure the quality of the study conduct and study data:

• Efforia
• The Office of Human Research Protections (OHRP);
• Univo Institutional Review Board; and
• University of Portsmouth Ethics Review Board
• Other regulatory agencies

Once your protected health information has been shared with authorized users, it may no longer be protected by federal privacy laws and could possibly be used or disclosed in ways other than what is listed in this section.

Your permission to use and share protected health information about you will end after you have completed the study and any after study related activities unless you revoke your permission sooner.

You can revoke your permission to use and share protected health information about you at any time by contacting the study doctor listed on the first page of this document. If you revoke your permission, you will not be able to stay in this study. No new protected health information will be collected after your request has been received. The protected health information about you that has already been collected may still be used and given to others as described in this section.

If you decide not to sign and date this document, you will not be able to take part in the study. However, you may continue to use and consume anything you've purchased to be part of the study outside the study.

California Experiential Research Subject’s Bill of Rights

Participants have rights under the California Experiential Research Subject Bill of Rights. For more details, please refer to the Efforia privacy policy here: https://efforia.com/privacy-policy/.

Who to Contact for Questions or Concerns

If you have questions, concerns, or complaints about this study or to report a study related injury, contact:

HELP@EFFORIA.COM
OR CLICK THE CHAT BUTTON ON YOUR SCREEN
We will immediately respond with an automated message giving you a sense of how long a more meaningful response will take based on the volume of other requests.

(646) 679-2479. If no one is available, please leave a message. We will typically respond to telephone message in three to five business days.

If you are unable to reach anyone at the number(s) listed above and you require immediate (life threatening) medical attention, please dial 911 in the US/Canada or 999 in the UK and/or go to the nearest emergency room.

If you do not want to talk to the investigator or study staff, if you have concerns or complaints about the research, or to ask questions about your rights as a study subject you may contact Univo IRB. Univo IRB is an independent committee that helps to protect the rights and welfare of research participants. If you have any questions about your rights and welfare as a research participant, or have concerns or complaints regarding this research study, please contact:

Univo IRB
(919) 910-7743 or via email at info@univo-group.com
Univo IRB
4509 Creedmoor Road Suite 403
Raleigh, NC 27612

Additional questions and closing

Efforia and Univo have approved the information in this consent form and have given approval to publish this study. This does not mean Efforia or BRANY have approved your being in the study. You must consider the information in this consent form for yourself and decide if you want to be in this study.

If you have questions, please contact help@efforia.com. It is up to you to do additional research and talk to your physician before joining a study.