OUR TRANSITIONS STUDY
How do I participate?
If you are interested in participating in the Our Transitions study, please use this link to provide your contact information and answer a few pre-screening questions to see if you’re eligible. You will then be contacted by a study team member via email. If you would prefer to speak directly to a member of our study team please contact: ourtransitions@4youandme.org.
What is the goal of this study?
This study is being conducted to help determine the feasibility of using multiple wearable study devices and smartphone apps to detect, track and learn how to share insights about symptoms during the path to menopause and the time right before. The study investigators will seek your input as a co-designer to understand what is helpful and not helpful about the use of these tools in the context of your experience. The eventual aim of this work is two-fold; 1.) to increase knowledge, awareness and education for individuals and clinicians about the lived experience of perimenopause, and menopause and the time right before through objectively measured data from digital study devices, and 2.) to develop digital approaches to empower female individuals to manage this transition by learning what improves or worsens their symptoms.
Who can participate?
We are currently recruiting 250 participants. You don't have to be in perimenopause to join this study! We still want to understand your experience before your transition to this stage.
To be eligible for the Our Transitions study, you must:
- Be 35-55 years old
- Reside in the US
- Be able to speak, write, and read English
- Be able to provide informed consent
- Have a personally owned mobile phone iOS (Version 16.4 or newer)
- Be willing to use the study app that should take on average 5 minutes per day
- Be willing to use and wear the study devices (Oura Ring Gen 4 and Fitbit Sense 2) for the duration of the study
- Are not taking the birth control pill or hormonal intrauterine device (IUD), and are not taking systemic estrogen or progesterone*
We understand that many female individuals use hormone contraceptives/therapies. While you cannot participate in this initial Our Transitions Study if you are currently using hormone contraceptives/therapies, there will be future opportunities to participate in this research that does not include this exclusion criteria. Please check out our website for updates/or let us know if you would like to be contacted for upcoming study opportunities.
How long will the study last?
Your participation is completely voluntary and you are invited to participate in this study for 6 to 12 months.
What will I do in the study?
If you participate in this study, you will be expected to:
- Download the study app
- Complete brief surveys and tasks when prompted in the study app
- Interact with additional optional features in the study app to log your personal experiences
- Wear the wearable study devices provided to you (or your own) and allow researcher access to the collected passive data streams
- In a subset of participants, complete at-home urine hormone tests provided to you for 3 consecutive menstrual cycles
- In a subset of participants, use a new investigational wearable (Vire) clip capable of capturing core body temperature through heat flow, the dynamics of respiratory effort, and skin conductance measures at multiple layers into the skin
- Check in with study staff every 2 weeks and give feedback on your study experience
Will I be compensated for participating in the study?
The study will not provide any compensation or reimbursement for participation. Participants can keep their Oura Ring and Fitbit after they complete the study.
Who is conducting this study?
This study is being conducted by 4YouandMe - a non-profit organization that conducts research into digital technology and health (www.4youandme.org) in partnership with WLB. Women Living Better (www.womenlivingbetter.org) improves the experience of the path to menopause through research and education.
Do you have further information for me to read?
Yes! Follow this link for the Our Transitions Study frequently asked questions. If you would prefer to speak directly to a member of our study team, please contact: ourtransitions@4youandme.org