What You Need to Know to Participate
This document provides information to help you decide whether to join this research study. It is important you understand the responsibilities, risks and benefits of participating.
INFORMED CONSENT DOCUMENT AGREEMENT TO BE IN A RESEARCH STUDY
Challenge/Study Title | Nature Walks and Yoga Sessions for Testosterone Boost |
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Challenge Coach (The Person in Charge of This Research Study) | Illia Pantsyr |
Sponsor | This study is made possible by your payment to join. |
Challenge Cost | $0 |
Included Products & Services | Free Testosterone Test Kit |
Outcome Measures | Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS), Burnout Measurement Survey, Blood Testosterone Test |
Contact | help@efforia.com |
Introduction to the Study
Welcome to the "Nature Walks and Yoga Sessions for Testosterone Boost" research study on the Efforia platform. This study is made possible by your support. The purpose of this document is to provide you with all the information you need to decide whether to participate in this study. If you have any questions or need further clarification, please seek answers before proceeding.
What's Involved
Participant Responsibilities in the Study
Welcome to the "Nature Walks and Yoga Sessions for Testosterone Boost" study! This 30-day program aims to enhance your physical and mental well-being through daily nature walks and yoga sessions. Below is a detailed overview of your responsibilities, schedule, and the critical importance of adhering to the timeline.
Overall Schedule and Specific Timeline
- Day 1-30: Participate in daily nature walks and yoga sessions.
- Day 1, 15, 30: Complete the Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS) and Burnout Measurement Survey.
- Day 30: Use the Free Testosterone Test Kit and submit your results.
Detailed Description of Treatment Activities
- Daily Nature Walk
- Engage in a moderate cardiovascular exercise by walking in nearby natural environments.
- Yoga for Testosterone
- Participate in daily yoga sessions specifically designed to boost testosterone levels. Each session will be guided and should be followed as per the instructions.
Frequency and Measurements
- Daily Activities:
- Nature Walks: Daily
- Yoga Sessions: Daily
- Surveys and Tests:
- Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS): Conducted on Day 1, 15, and 30.
- Burnout Measurement Survey: Conducted on Day 1, 15, and 30.
- Free Testosterone Test: Conducted on Day 30.
Importance of Adhering to the Timeline
Strict adherence to the prescribed schedule is crucial for several reasons:
- Participant Safety: Following the schedule ensures consistent monitoring, which is essential for your safety throughout the study.
- Optimal Personal Outcomes: Regular participation in the activities maximizes the benefits to your physical and mental well-being.
- Scientific Validity and Success of the Study: Consistent and accurate data collection is vital for producing reliable and meaningful results, contributing to the overall success of the research.
Your commitment to following this protocol is highly appreciated and instrumental in realizing the study's objectives. Thank you for your participation and dedication!
The Purpose of This Study
This study aims to investigate the effects of daily nature walks and yoga sessions on testosterone levels and overall mental well-being. We use the Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS), Burnout Measurement Survey, and Blood Testosterone Test to measure outcomes. By participating, you contribute to scientific knowledge and societal benefits, potentially helping others improve their health and well-being.
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.
Privacy and Confidentiality
Your personal information is protected through robust measures ensuring anonymity or confidentiality. All data processing by AI systems is designed to safeguard personal data against unauthorized access and misuse.
Respect and Personal Choice
All participants are treated with dignity and respect, acknowledging their autonomy and decision-making capabilities, particularly to join studies that might not otherwise be possible under a traditional funding model.
Maximized benefit and minimized risk
The design and execution of this study aim to maximize benefits and minimize harm to participants. This includes continuous monitoring for any adverse effects during participation.
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.
Feedback Mechanism
A email customer support process for providing immediate feedback or filing complaints regarding the study or its methodology and a promise that we will address and respond within 2 business days.
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.
Risks and Benefits
Report on Potential Risks Associated with the Free Testosterone Test Kit and Protocol Overview for Nature Walks and Yoga Sessions for Testosterone Boost
Introduction and Summary of Known Risks
The Free Testosterone Test Kit, combined with the Nature Walks and Yoga Sessions for Testosterone Boost protocol, aims to provide a holistic approach to naturally enhancing testosterone levels through daily physical activity and mindfulness exercises. The primary components include moderate cardiovascular exercise (nature walks) and yoga, both of which have been shown in various studies to positively influence testosterone levels and overall mental well-being.
However, it is crucial to recognize that even natural and non-pharmacological interventions can carry risks. This report details the known risks, side effects, allergies, and adverse reactions associated with the protocol. 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.
Maximum Dosages and Side Effects
The nature of this protocol revolves around physical activities rather than chemical dosages. However, over-exertion during exercise can lead to adverse effects.
- Nature Walks: Evidence suggests that moderate cardiovascular exercise (e.g., walking 30 minutes a day) is generally safe for most individuals. However, excessive walking beyond one's physical capacity can lead to joint pain, muscle strain, and fatigue.
- Yoga: Practicing yoga within one's limits is typically safe, but over-stretching or performing advanced poses without adequate preparation can result in muscle strains, joint dislocations, or other injuries.
Serious Adverse Events (SAEs)
- Incidence of Cancer: There is no direct evidence linking nature walks or yoga to cancer risk. However, physical exercise is generally associated with a reduced risk of certain cancers.
- Exacerbation or Escalation to Acute or Chronic Disease: Individuals with pre-existing cardiovascular conditions may experience exacerbations if physical activities are not moderated appropriately.
- Death: Extremely rare but possible in cases of severe over-exertion or pre-existing serious health conditions.
- Life-threatening Experience: Rare but can occur due to severe dehydration, heat stroke, or cardiac events during intense physical activity.
- Hospitalization (Initial or Prolonged): Possible if injuries or severe medical conditions arise during activities.
- Disability or Permanent Damage: Potential if severe injuries occur, such as fractures or severe muscle tears.
- Congenital Anomaly/Birth Defect: Not applicable.
- Required Intervention to Prevent Permanent Impairment or Damage: Necessary in cases of severe injuries or health conditions arising from the physical activities involved.
Other Serious Medical Events
- Severe Dehydration and Heat Stroke: Particularly relevant in hot climates or for individuals not adequately hydrating during activities.
- Cardiac Events: Especially in individuals with undiagnosed or pre-existing heart conditions.
Minor and Moderate Adverse Effects
- Gastrointestinal Symptoms: Rarely reported but possible due to physical exertion or stress.
- Skin & Hair Reactions: Contact dermatitis from outdoor elements or yoga mats.
- Headaches: Can result from dehydration or over-exertion.
- Fatigue: Common, especially in the initial stages of increased physical activity.
- Dizziness: Can occur during yoga positions or due to low blood sugar/dehydration.
- Mood Changes: Generally positive due to endorphin release, but initial fatigue may cause irritability.
- Sleep Disturbances: Usually improves with regular exercise, though initial changes in routine may disrupt sleep temporarily.
- Weight & Body Composition Change: Generally positive, with potential weight loss and muscle gain.
- Muscle or Joint Pain: Common, especially if activities are not performed correctly or are overdone.
- Mental Health Discomfort: Initial stress from new routines or physical exertion.
- Sexual Side Effects: Generally positive, with potential enhancement in libido.
- Personal Appearance Change: Possible weight loss or muscle gain.
- Cognitive Impairment, Intoxication, or Loss of Control: Unlikely, except in cases of extreme fatigue.
- Athletic Impairment: Over-exertion can temporarily reduce athletic performance.
- Breathing or Respiratory Issues: Rare, but possible during intense physical activity or in individuals with respiratory conditions.
In the Case of an Adverse Event
If you experience any serious adverse events, seek immediate medical care. It is critical to inform your healthcare provider of the activities you have been engaging in as part of this protocol. Efforia's limitations in providing direct medical support mean that while we offer guidance and support through our program, we cannot provide emergency medical assistance.
Long-term Dependence Issues
There is no evidence suggesting long-term dependence issues associated with the nature walks and yoga sessions. These activities are meant to foster long-term healthy habits rather than dependence.
Legality for Use by Various Institutions
- World Anti-Doping Association (WADA): The activities involved in the protocol do not involve any banned substances; however, athletes should always confirm with their regulatory bodies.
- National Collegiate Athletic Association (NCAA): Similar to WADA, the activities should be permissible, but confirmation with institutional regulations is advised.
- Corporate Workplace: Generally, participation in such wellness activities should not affect employment status, though employees should verify with their HR departments to ensure compliance with workplace policies.
Conclusion
While the Free Testosterone Test Kit and associated wellness protocol offer substantial benefits, it is essential to approach it with caution and awareness of potential risks. Always consult healthcare professionals familiar with your health history before beginning new physical activities.
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.
No Benefit: A key risk to all studies is that there is no benefit, and that participants receive no benefit from the proposed intervention or treatment, despite the financial payment the participant has made.
Acknowledgment of Risk and Responsibility
There are some unique responsibilities for participants in citizen science trials. This includes some risks that participants should understand. Efforia does not endorse or sponsor this trial. It is simply hosted on the Efforia platform. Here are the specific considerations:
Consider your Own Risk-Benefit Comfort Level
Participants are encouraged 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. It is possible that not all risks and benefits are currently known. Participants have the responsibility to consult with their healthcare providers and conduct further research before enrolling in the study.
Responsible for any Additional Costs & Medical Care
In the case of an adverse event, it is the participant's sole responsibility to seek and finance their medical treatment. Efforia, as a non-sponsor, is absolved from any claims and cannot reimburse any expenses incurred.
Reporting Adverse Events
It is crucial for participants to report any adverse events to Efforia. This allows the sharing of such information with other participants, promoting overall safety and awareness within the community.
The Limits of Efforia Medical Oversight
It is important to understand that if the study involves any lab tests or items requiring a prescription, asynchronous medical oversight will be available to assist in mitigating risks. However, participants should understand that this oversight does not replace personal responsibility or the need for local medical care.
Legal Acknowledgment
This document serves as a legally binding acknowledgment of the risks associated with participating in a study and explicitly limits Efforia's liability. Efforia will not be held liable for any claims except in cases of gross negligence or willful misconduct. This acknowledgment underscores the importance of personal diligence and responsibility throughout the study participation.
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 or conflicts of interest. We are not paid by the sponsor of this study. 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, or otherwise push you to join the study.
How we Reduce 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 a participant fail to disclose such a conflict of interest or if a breach of this policy is discovered, the participant will be subject to immediate suspension from this platform. Further, depending on the nature of the violation, additional legal proceedings may be initiated as warranted by law to address the breach adequately.
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
Data will be collected, used, and protected in compliance with data protection laws. Your personal data will be anonymized or kept confidential, and access to your data will be restricted to authorized personnel only. Efforia uses advanced security measures to protect your data from unauthorized access and misuse.
California Experiential Research Subject’s Bill of Rights
Participants in California are entitled to a summary of their rights as research subjects. Please refer to the California Exper