CONSENT TO PARTICIPATE IN A RESEARCH STUDY AND PRIVACY POLICY
THE CITY UNIVERSITY OF NEW YORK
Graduate School of Public Health and Health Policy (CUNY SPH)
Title of Research Study: Developing a Tailored, Theoretically-Driven Smartphone Physical
Activity Intervention for African American Women (Open Pilot Trial)
Principal Investigator: Marie Aline Sillice, Ph.D.
Co-Investigator: Terry Huang, Ph.D., MPH, MBA
Research Sponsor: This study is being paid for by a grant from the National Institute on Minority Health and Health Disparities
You are being asked to participate in a research study you identify as Black or African American and woman, and you are not physically active. You have also indicated that you own a smartphone with a text messaging data plan.
Nature and Purpose:
The purpose of this research study is to evaluate a smartphone application (PA4Health app) focused on increasing physical activity among African American women. You have been invited to participate because you identify as an African American woman, and you are not physically active. You have also indicated that you own a smartphone with a text messaging data plan. Your participation in the study will last 10 weeks. It will require two orientation sessions that you can choose to complete via a secured online platform, Zoom, or in-person at the CUNY SPH. The first orientation session consists of an interview on your physical activity behaviors and instructions on how to use an accelerometer used to measure your current level of physical activity (15-30 minutes). The second orientation consists of an overview of the PA4Health app, downloading the app, and completing a baseline assessment before starting the 8-week program. This session ranges from 40-60 minutes. During the program, you will receive a daily motivational text message developed to address your needs for physical activity and complete a short survey at the end of week 4. At the end of the intervention (week 8), you will be invited to complete a survey about your experience using the app. All surveys are completed through the PA4Health app. Moreover, you will be asked to wear the small accelerometer device for 7 days at week 8. Lastly you will be asked to complete a qualitative interview to learn more about your experience with the program and potential recommendations for improvement. The interview will be conducted over the telephone and will likely be at least 20 minutes in length.
To decide whether or not you wish to be a part of this research study, you should know enough about its risks and benefits to make an informed judgment. This consent form gives you detailed information about the research study. The consent for should go over all aspects of this research: its purpose, the procedures that will be performed, risks associated with the procedures, possible benefits of participation, and possible alternatives. Once you understand the study, you will be asked if you wish to participate; if so, you will be asked to sign this form. This consent may contain words that you do not understand. Please ask the investigator or the study staff via email or telephone to explain any words or information that you do not clearly understand.
Explanations of Procedures:
Baseline Assessment and Medical Clearance
If you decide to participate, you will first complete orientation session 1, which consists of an interview to confirm that you are eligible for the study. In this interview, you will be asked about your level of physical activity and your physical health. This confidential interview will be video and or audio recorded. If you choose to complete the session via Zoom, recording through this platform automatically includes video. The video recording will be deleted after the session. The audio recording will be reviewed by the researchers for training/supervision purposes. In addition, you will be asked to wear an accelerometer (e.g., a small device that counts your movements so that we know how active you are). The accelerometer will be given to you, and you will be asked to wear it for up to 1 week. This device is worn around your waist. You will wear the accelerometer whenever you are awake, except when you are in the shower, swimming, or other times it would get wet. You will return the accelerometer to us in a pre-stamped envelope. We will use that information, along with the survey you will complete, and help you to set an initial weekly step goal for physical activity, which will take place in orientation session two. We must receive the accelerometer before we can schedule the second session.
If you report any medical conditions, we will need medical clearance from your doctor to indicate whether or not you are healthy enough for this study. With your permission, we will inform your primary care physician of your participation in this study and, in some cases, request from your PCP that he/she is medically clear for you to start exercising. However, it is your responsibility to tell the study staff of any current medical conditions and/or changes in your medical status or health that take place during the study to make sure you continue to be healthy enough to participate in the exercise program.
It is possible that, based on the interview and medical clearance form, you will not be found eligible to participate in this study.
PA4Health Smartphone app
Orientation session two: This consists of an overview of the PA4Health app, downloading and installing the application on your smartphone. You will also be given an activity tracker, Fitbit Charge 3, which counts your movement or level of physical activity to wear daily while you are in the study. With your permission, we will create a study email address and Fitbit account just for you to use with your activity tracker. We will help you customize your Fitbit and show you how to use it and login to your Fitbit account. Dr. Sillice or research staff will be able to access your Fitbit account during the study in order to download your data. Research staff will authorize an encrypted data platform called Fitabase to access and download your Fitbit data for the duration of this study. This authorization will not include sharing any personal health information. Research staff will use your de-identified Fitbit account information to authorize Fitabase to access your data. A de-identified study ID number will also be used within the Fitabase platform. Research staff will access and download the following data gathered from your de-identified Fitbit account:
During the 8-week PA4Health program, you will receive one daily motivational text based on your baseline survey to help address your reported barriers to physical activity or exercise. Moreover, you will receive a message at the end of each week based on the number of steps completed. At week 4 , we will ask you to complete a brief survey to determine whether your barriers and facilitators to physical activity have changed. The information collected at the end of week 4 and will be used to provide you with daily motivational intervention messages tailored to your needs. All surveys will be completed through the app. Another feature of P4Health is Education, which includes information on various physical activity related topics (e.g., proper form, hydration) shown to be useful in helping individuals start and remain physically active. Moreover, you will be able to change your weekly step goal by using the Steps feature of the app.
Moreover, the PA4Health app will guide you to engage in physical activity that is moderate in intensity (e.g., the pace of a brisk walk, where your heart rate is increased, but you can still hold a conversation). The PA4Health app will provide encouragement for engaging in physical activity. Moreover, to help increase your level of physical activity, you will be encouraged to make weekly progress toward achieving public health recommended levels of physical activity, which 150 minutes/week of moderate-intensity exercise. Further, a Locator feature of the app allows you to find places near to exercise (e.g., parks, running trails) using your location zip code. Study staff will monitor the use of the PA4Health app and may contact you by text message if you have not opened the app in several days to remind you to use the app.
At the completion of the study, the PA4Health app system will be deactivated. You will simply remove the app from your phone using the instructions that will be provided to you. The Fitbit Charge 3 is yours to keep; however, we will no longer record or monitor data from this device.
Assessments
You will complete a short survey at the end of week 4 on barriers to physical activity and strategies to help engage in this behavior regularly. At the end of the intervention (8 weeks), you will complete a survey that consists of questions about your level of physical activity, your usability of the various app components, and your overall satisfaction with the app. You will be contacted by staff to schedule the qualitative interview to be conducted starting up to a week after the intervention.
Qualitative Interview
After completing the 8-week intervention, you will complete a single interview that will explore more about your experience with the program and your recommendations to improve similar future programs. If you decide to participate, the study staff will schedule a day and time to complete the interview. The length of the interview is at least 20 minutes.
Zoom Platform
You have the option of attending orientation sessions via Zoom. We are using a Zoom business account that provides encrypted services to protect against security issues, including hacking. Prior to the meeting, a research staff will send a meeting ID and a password to you via email or text message before the session. After logging into Zoom, you will be directed to a virtual "waiting room." Then, the research staff will see who is waiting and allow you to join the meeting. This security step prevents anyone who is not a participant from entering the session. After being admitted to the meeting, a research staff will change your name to a study ID (e.g., ID 100) to protect your privacy and for data collection. You will participate in the session using the Zoom video and audio features.
Zoom demonstration
This platform is easy to use. You have the option to attend a brief demonstration session with a research staff. You will receive a "teach sheep" on how Zoom works for the purpose of the session.
Audio and Video Recording Study Assessments
We will audio record the interview in session one and the counseling session in session two. We do this to make sure that study staff are following study procedures in the correct way and also to make sure that we have correctly recorded the information that you share with us. However, Zoom automatically provides video recordings of a meeting or session. Only your study ID appears in the recording. Each video recording will be downloaded and stored on a password-protected folder and password-protected computer/server after the session. A research staff will review the recording and then delete the file. We will tell you whenever we plan to record. You may refuse the recording of the study assessments and still participate in the study.
Audio-Qualitative Interview
Each interview will be audio-recorded. Each audio file will be downloaded and given an ID number and stored on a password-protected folder and password-protected computer/server. Each audio file will be transcribed verbatim. Each transcribed interview will contain a label and no identifying information. All recordings will be destroyed after transcriptions. You can refuse to complete the qualitative interview.
Time Commitment:
Your participation in the study will last 10 weeks. It will require that you complete two orientation sessions (sessions one and two are expected to last up to 30 and 60 minutes, respectively) at baseline before starting the 8-week PA4Health app intervention. You can choose to complete the sessions via Zoom or in-person. For an in-person session, CUNY SPH requires a proof vaccination card for everyone entering the building. During the program, you will receive a daily motivational text message. You will be asked complete a brief survey at the end week 4 to help deliver motivational messages to you that meet your needs for physical activity. Each survey takes 10-15 minutes to complete. At the end of the intervention (8 weeks), you will be asked to complete an online survey that requires up to 35 minutes to complete. Two-seven days following the completion of the intervention, you will be asked to complete a qualitative interview to learn more about your experience using the PA4Health app. The interview will be conducted over the telephone and the length of time is at least 20 minutes.
Potential Risks or Discomforts:
Using the Zoom Platform: There are some minimal risks: Zoom meetings have been hacked – like photo-bombing a video. However, this has happened with non-encrypted accounts. The study Zoom account is encrypted and password protected.
Engagement in physical activity: There are minimal risks associated with participating in a regular physical activity program, such as the one we offer in this study. You may experience general fatigue during your participation in these activities. You may also experience sprains, muscle pulls, shin splints, or bone injuries. Careful loyalty to your physical activity goals will help to prevent such injuries. In addition, during exercise, your heart rate and blood pressure will increase, and under extreme conditions, this can lead to a serious cardiac event (such as a heart attack). The possibility of experiencing a serious cardiac event has been estimated to be less than 2 per 20,000 in exercising adults.
You may experience discomfort from some of the assessment questions or discussion points of the qualitative interview. You may refuse to answer any questions that make you feel uncomfortable, and you can stop participating in the discussion at any time.
All information obtained will be confidential. Your responses to the questions will not be linked to any information that can identify you as an individual. Your information will be available only to our research staff. In addition, the PA4Health app will be password protected so that only you can have access to the information. Your name will never be associated with publications from this project.
Texting
We will contact you by text message for the purposes listed below:
How do Text Communications Work?
Text messages from the study staff will be sent from a phone that is dedicated for use in this research study. The phone will not be monitored for return messages constantly, but it will be checked periodically during regular office hours. You can respond to messages from researchers by sending them text messages, but there are only certain things you should communicate via text message.
Risks Related to Text Communication
You should be aware that there are risks associated with sending your health information via text. There is always a risk that the message could be intercepted or sent to the wrong number. Text messages from research staff may contain health information that identifies you. Only the research team will have access to your text communications. We will only communicate by text to send you the information listed above. We will not send text messages that contain urgent information. We will not send text messages to a group of recipients. If you share your mobile phone or messages with others, you risk losing privacy surrounding your health information and loss of privacy surrounding your participation in this study. You should make sure to protect your phone with a password if you send or receive text messages during participation in this study.
Cautions related to text messages with researchers
Text messages may not be received by researchers on a regular basis. It is possible that a message you send will go unnoticed or will not be read by the research team for days or weeks. You should use the telephone to contact the research team for any urgent matters. Medical issues (symptoms, side effects, injuries, concerns about the effects of study procedures, etc.) should NOT be communicated by text message. These should be directed to the research staff by telephone or in-person. To discuss medical issues, please contact our office at 347-798-7784.
Potential Benefits:
We cannot and do not guarantee or promise that you will receive any benefits from this study. If you increase your level of physical activity, you may experience direct benefits such as increased fitness, including improved cardiovascular health, decreased blood pressure, decreased blood cholesterol levels, and changes in body composition. You will also receive a Fitbit Charge 3 that you will be able to keep after the study is finished. Lastly, the knowledge gained in this study will help to inform the development of future and similar studies.
Alternatives to Participation:
This study includes interventions designed to help African American/ Black women safely increase physical activity. You may also seek to begin an exercise program on your own, with your physician’s advice to do so, and utilize community resources such as gyms, bike paths, etc.
Please Note
Given the additional medical monitoring associated with increased physical activity during pregnancy, if you are pregnant or intend to become pregnant in the next 10 weeks, you will not be eligible to participate. We will specifically ask you to let us know if you change your mind and decide to become pregnant during the study.
New Information:
You will be notified about any new information regarding this study that may affect your willingness to participate in a timely manner.
Confidentiality:
We will do our best to maintain the confidentiality of any information that is collected during this research study and that can identify you. Personal identifiers will be removed from any identifiable private information about you in the final research dataset created by this study. The de-identified information may be used for future research studies or distributed to another investigator for future research studies without additional informed consent from you (or your legally authorized representative).
The research team, authorized CUNY staff, the National Institute on Minority Health and Health Disparities, and government agencies that oversee this type of research, may have access to research data and records to monitor the research. Research records provided to authorized, non-CUNY individuals will not contain identifiable information about you. Publications and/or presentations that result from this study will not identify you by name.
To keep your information safe, we will store all information in locked file cabinets and on password protected, secure computer servers. To the extent possible, we store identifying information (such as your name or address) separately from study data (such as questionnaires that you complete). All identifying information will be destroyed 7 years after the completion of the study.
If you tell us something that makes us believe that you or others have been or may be physically harmed, we may report that information to the appropriate agencies. General information about this study has been or will be submitted to the federal clinical trial registry databank, which can be accessed on the Internet at www.ClinicalTrials.gov.
This research is covered by a Certificate of Confidentiality. Unless you give special written permission, the researchers and CUNY cannot give out any information about you that could potentially identify you or be used as evidence in a legal case (including any federal, state, or local civil, criminal, administrative, or legislative case).
The only situations where researchers would share your information with others are:
(1) when a specific law (federal, state, or local) requires that potentially harmful things be reported to the authorities (such as reporting child abuse, elder abuse, or the spread of communicable diseases);
(2) when you have given permission (consent) for the information to be shared in order to help your medical treatment; or
(3) when your information will be used for other scientific research, as allowed by federal regulations protecting research subjects.
Privacy Policy
If you sign this document, you give permission to Dr. Sillice and Dr. Huang (Study Directors) at CUNY to use the health information that identifies you for the purpose of conducting the research study described above.
Your health information related to this study may also be shared with and used by individuals outside of CUNY, including:
Your health information may also be shared with a public health authority that is authorized by law to collect or receive such information for the purpose of preventing or controlling disease, injury, or disability, and conducting public health surveillance, investigations, or interventions. The U.S. Food and Drug Administration (FDA) may inspect all study records to ensure that the study is being conducted in accordance with FDA regulations.
CUNY is required by law to protect your health information. Individuals outside of CUNY that receive your health information may not be required by Federal privacy laws (such as the HIPAA Privacy Rule) to protect it, so we cannot guarantee that they will not share it without your permission.
Participants’ Rights:
Questions, Comments, or Concerns:
If you have any questions, comments, or concerns about the research, you can talk to one of the following researchers:
If you have questions about your rights as a research participant, or you have comments or concerns that you would like to discuss with someone other than the researchers, please call the CUNY Research Compliance Administrator at 646-664-8918 or email HRPP@cuny.edu. Alternatively, you may write to:
CUNY Office of the Vice Chancellor for Research
Attn: Research Compliance Administrator
205 East 42nd Street
New York, NY 10017