Evaluating the capability of emergent assessment methods to advance physical behavior research in Oklahoma

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INTRODUCTION

This research study  is being conducted by Eric Wickel, PhD (primary investigator, PI). This document defines the terms and conditions for being in this study.

WHY IS THIS RESEARCH STUDY BEING DONE?

Results from this study will be used to explore how wearable devices and self-report tools can improve our understanding of daily physical behavior.

WHAT KEY INFORMATION DO I NEED TO KNOW TO HELP ME DECIDE TO PARTICIPATE IN THE STUDY?

What am I being asked to do?
If you agree to be in this study, you will be asked to:

Spend less than 5 minutes answering a single questionnaire about your personal characteristics, employment and income, household information, daily behavior, and general health. Attach and wear a small and lightweight device on your thigh (2.3 × 4.3 × 0.5 cm; 9 grams) and wrist (4.6 × 3.3 × 1.5 cm; 19 g) during a continuous monitoring protocol lasting up to seven days. The wearable devices will be sent directly to your physical address. Complete an online previous-day activity recall on two randomly selected occasions. Each recall will take about 5 minutes to complete (5 minutes/recall × 2 recalls = 10 minutes total completion time). Return the wearable devices to the PI using a postage-paid envelope. Spend about 2 minutes completing a post-study survey about your experience with the assessment tools. During the seven-day monitoring period, you are expected to spend less than 20 total minutes completing self-report tools.

Any possible risks or discomforts to you?

No risks are associated with monitoring free-living behavior, but some discomfort may be associated with the devices. The thigh device attaches to the skin’s surface using a waterproof and latex-free adhesive cover. Some initial discomfort may exist with the attachment of the thigh device; however, much like wearing a band-aid, the novel sensation will diminish. Redness may be visible at the attachment site once the thigh device is removed, but this will go away within a day. The wrist device is similar in shape and size to a standard watch but may feel unfamiliar to a person not accustomed to wearing a watch.

Any direct benefits for me? No.

Any paid compensation for my time?

Yes, you can receive a check up to $100 by completing the entire study protocol. Participants completing the personal characteristics survey and returning both devices will receive partial compensation as outlined below.

• $10 for each complete day both devices were worn ($70 max) or $5 for each complete day the thigh device was worn ($35 max)

• $10 for each completed ACT24 recall ($20 max)

• $10 for completing the post-study survey ($10 max)

For this study, a complete day represents the time range from mid-night to mid-night.

Please note, the University of Tulsa requires identifying information to issue checks of any dollar amount and to track payments for tax purposes. To receive your check, you must complete the Compensation for Research Participation form included in the study material and return this form to the PI using the postage-paid return envelope. This form requires your name, social security number, physical address, and signature. Once the Compensation for Research Participation form is received by the PI, the compensation amount will be determined based on the payment guidelines and the form will be delivered by research personnel to the Office of the Controller within two business days to initiate the payment process. You should expect to receive your compensation check about 2 weeks after returning the wearable devices and compensation form to the PI.

What are the total number of subjects the researcher(s) will try and recruit for this study?

At least 300 participants.

How will my information and/or identity be protected?
You will be assigned an ID number that will be used in place of your name throughout the study. A master list containing your name and ID number will be stored in a designated folder on the PI’s password-protected university OneDrive account, separate from your data. Data obtained from the wearable devices and online surveys will be linked by your ID number and stored in a unique folder on the PI’s password protected university OneDrive account. Files will be accessible only to designated research personnel. The master list that links you to your data will be destroyed at the end of the study (August 1, 2026). Research personnel will deliver the completed Compensation for Research Participation form directly to the Office of the Controller. In the event research personnel are unable to deliver the Compensation for Research Participation form on the day of receipt, the forms will be stored in a unique locked file cabinet in the PI’s designated office space.

WHAT ARE THE CONDITIONS OF MY PARTICIPATION AND CAN I LEAVE THE STUDY BEFORE IT ENDS?

To participate, individuals must be at least 18 years old, reside in Oklahoma, and have accessible internet service and an email address. Participation in this research study is voluntary. Refusal to participate will involve no penalty or loss of benefits to which you are otherwise entitled. Your participation in this study is over after you have completed the described activities. However, you can leave the study at any time, even if you have not finished, without any penalty or loss of benefits to which you are entitled.

WHAT IF I HAVE QUESTIONS ABOUT THE PRIVACY PROTECTION FROM THE INTERNET SERVICER?

Qualtrics will collect your internet responses. Please note that Qualtrics may have specific privacy policies of their own. If you have any questions or concerns, you should consult Qualtrics directly at http://www.qualtrics.com/privacy-statement/.

ACT24 will collect information about your self-reported daily behavior. If you have any questions or concerns, you should consult their privacy and security statement at https://www.cancer.gov/policies/privacy-security#how-is-personal-information-protected.

The Actigraph wrist device will collect information about your daily behavior. If you have questions about their privacy and security policies, please consult Actigraph directly at https://theactigraph.com/privacy-policy.

The activPAL thigh device will collect information about your daily behavior. If you have questions about their privacy and security policies, please consult activPAL directly at https://www.palt.com/privacy-policy/.

CAN MY COLLECTED INFORMATION FROM THIS STUDY BE SHARED OR USED BY OTHERS?

Once personal identifiers have been removed from the identifiable private information, the de-identified information could be used for future research studies or distributed to other investigators for future research studies without additional informed consent from you or your legally authorized representative.

HOW WILL THE RESULTS BE USED?

Data from this study will be presented at academic conferences and/or within scientific documents. The data will not include personally identifiable information.

WHO CAN ANSWER MY QUESTIONS ABOUT THIS STUDY?

You can contact Dr. Eric Wickel by email (eric-wickel@utulsa.edu) or phone (918-631-2677).

WHO CAN ANSWER QUESTIONS ABOUT MY RIGHTS AS A RESEARCH SUBJECT?

You can contact the Coordinator of Research Compliance at the University of Tulsa (researchcompliance@utulsa.edu; 918-631-3310) or Dr. Eric Wickel at eric-wickel@utulsa.edu.

PARTICIPANT’S RIGHTS

You have been given an opportunity to read and discuss the informed consent and ask questions about this study;

You have been given enough time to consider whether or not you want to participate;

You have read and understand the terms and conditions and agree to take part in this research study;

You understand your participation is voluntary and that you may stop participation at any time without penalty.