Summary Information to Help you Decide Whether to Join this Study

Study Title	Magic Spoon Cereal Meal Replacement Study
Study Author	Matthew Amsden
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	$0
Included Products & Services	Magic Spoon Cereal Variety 6 Pack, Tasso Blood Collection Kit, Withings Sleep Mat, Test Product
Outcome Measures	General Anxiety Disorder (GAD-7), PHQ-8
Contact	help@efforia.com

Introduction & Summary

Welcome to the Magic Spoon Cereal Meal Replacement Study on the Efforia platform! Efforia is a registered Delaware B Corporation, which means we consider the public good in addition to traditional business goals. This study is made possible by your participation.

This study aims to see if replacing one meal a day with Magic Spoon cereal can help reduce anxiety and promote better health. The information in this document will help you decide if you want to participate. Your participation is voluntary, and you can leave the study at any time without penalty. If you choose to leave, you may still use the products and services provided. If you prefer not to use them, a partial or full refund may be possible depending on the study timeline. Contact Efforia by email at help@efforia.com for more information.

If you have any questions, please reach out to Efforia, do your own research, and talk to your healthcare provider before deciding to join this study.

Purpose of the Study

This study aims to understand the effects of replacing one daily meal with Magic Spoon cereal for 12 weeks. We will measure changes in anxiety (using the General Anxiety Disorder (GAD-7) Scale) and depression symptoms (using the Patient Health Questionnaire (PHQ-8)).

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.

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

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 and overall findings. These findings will be made available at various data collection points during 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 email to help@efforia.com.

Possible Benefits of Participation

Participation in this study may help you understand the impact of meal replacement on your weight, body measurements, anxiety levels, and depression symptoms. You may also contribute to scientific knowledge that can benefit others. 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

Risk Assessment and Management for Interventional New Drug/Treatment Application

Introduction

This document provides a detailed assessment of the risks associated with the use of Magic Spoon Cereal Variety 6 Pack, Tasso Blood Collection Kit, and Withings Sleep Mat as part of a controlled study. These assessments are essential for ensuring participant safety and compliance with regulatory standards.

Summary of Known Risks

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.

• Magic Spoon Cereal: Potential risks include allergic reactions to ingredients such as dairy or nuts, gastrointestinal discomfort, and possible nutrient imbalances with prolonged use as a meal replacement.
• Tasso Blood Collection Kit: Risks include bruising, infection at the collection site, and stress or anxiety induced by self-administration of the blood draw.
• Withings Sleep Mat: Potential risks are minimal but may include discomfort due to the mat's presence, inaccurate sleep data affecting stress levels, and dependency on technology for sleep monitoring.

In the Case of an Adverse Event

If you experience any severe or unexpected symptoms, immediately call 911 for emergency medical assistance. Once you are safe and your immediate health concerns are addressed, please inform Efforia about the adverse event. This communication helps us to monitor the safety and efficacy of our product and make necessary adjustments.

Serious Adverse Events (SAEs)

Theoretical side effects	Relative incidence	Recovery
Frustration and irritation	Low to moderate	Subsides with use
Allergic Reactions (Cereal)	Low	Corrects after discontinuation
Infection (Blood Kit)	Very low	May require medical intervention
Data Privacy Concerns (All devices)	Low	Long-term monitoring and policy adherence

Efforia's limitations in providing direct medical support

Efforia is primarily a research and technology organization and does not provide direct medical services. Participants are encouraged to maintain regular communication with their healthcare providers throughout the duration of the study.

Long-term Dependence

Long-term dependence on the Withings Sleep Mat for sleep monitoring may discourage natural sleep hygiene practices. Additionally, prolonged use of meal replacements like Magic Spoon Cereal could lead to nutrient deficiencies if not managed properly.

Legality and Compliance

The use of these products does not violate any laws but participants in regulated activities such as sports or certain professions should verify the compliance of the Tasso Blood Collection Kit and Withings Sleep Mat with relevant organizations including the World Anti-Doping Association and the National Collegiate Athletic Association. Corporate workplace policies may also affect the permissible use of these monitoring devices during work hours.

This document aims to provide comprehensive risk information but is not exhaustive. Continuous monitoring and reporting of all health interventions are crucial for maintaining safety and efficacy.

Inappropriate Participants Inclusion/Exclusion

Under the Efforia minimal risk protocol, within which this study is reviewed for safety and human subjects ethics, all individuals over the age of consent are eligible, however, it is the responsibility of participants to determine if their unique circumstances make participation inappropriate.

Category of Individual	Contraindications	Reason
Individuals with kidney disease	High-protein diet	High-protein intake can exacerbate kidney function issues.
Diabetics	Low-carb diet	Altered carbohydrate intake can affect blood sugar levels unpredictably.
Pregnant or breastfeeding women	Dietary changes	Nutritional needs are different; potential risk to mother and child.
Individuals with eating disorders	Focus on weight loss and body composition	May trigger or worsen disordered eating behaviors.
Individuals with known allergies to ingredients in Magic Spoon cereal	Specific allergens	Risk of allergic reactions.
People with metabolic disorders	Changes in macronutrient intake	Could destabilize metabolic control.
Individuals on medications for chronic conditions	Possible diet-medication interactions	Diet changes may affect medication efficacy or cause adverse reactions.
Underweight or malnourished individuals	Low-carb diet focus on weight loss	May lead to further weight loss and nutritional deficiencies.
Individuals with gastrointestinal disorders	High-protein, low-carb diet	Potential for digestive discomfort or exacerbation of symptoms.
People with cardiovascular disease	High-protein diet	Some high-protein diets might increase cardiovascular risk factors.

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 a 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 study-related injury, please seek local medical care first if necessary. Efforia cannot provide emergency medical care or diagnosis. However, it is important to contact Efforia to make sure 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

Since this study is for research only, 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 also have a role in reducing conflicts of interest. 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

Your data will be collected, used, and protected in compliance with data protection laws. You own your data, and it will be housed on Efforia indefinitely until you otherwise tell us to delete it by emailing 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 email, 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 email 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 also be partners who 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 in California have specific rights regarding their involvement in research. For more information, please refer to the Efforia privacy policy: 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 messages 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.
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 Univo 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