Clinical trial: NCT04947150
Section: Confidentiality
Subsections: What Happens To The Information Collected For This Research?

Your private information will be shared with individuals and organizations that conduct or watch over this research, including:  
- The research sponsor(s): National Cancer Institute (NCI) - People who work with the research sponsor(s)
- Government agencies, such as the Food and Drug Administration or the Department of Health and Human Services
- The Institutional Review Board (IRB) that reviewed this research
- Drexel University and its affiliates
We may publish the results of this research. However, we will keep your name and other identifying information confidential.  
We protect your information from disclosure to others to the extent required by law. We cannot promise complete secrecy.  
  
 Protocol 2003007695A003 Approval Date: *03/25/2021*
Data or specimens collected in this research might be de-identified and used for future research  
 or distributed to another investigator for future research without your consent. A description of this clinical trial will be available on http://www.clinicaltrials.gov/, as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time.
Clinical trial: NCT04947150
Section: Participant Responsibilities
Subsections: What Are My Responsibilities If I Take Part In This Research?

If you take part in this research, you will be responsible to:
- Attend all required study visits and assessments via Zoom. - Shop at one of the approved grocery stores and use your loyalty card and/or designated credit card while checking out. These stores include: Target, Walmart, Wegmans, and ShopRite. If you fail to use your credit card/loyalty card at time of purchase, send the study staff a photo of your receipt.  
- Download the designated smartphone application and allow for notifications. If applicable, allow for the app to track your location in order to be sent messages while grocery shopping.  
- Read all messages sent to you.  
- Participate in all phone calls with your coach.  
- Contact the investigator if any complications arise.  
  
 Protocol 2003007695A003 Approval Date: *03/25/2021*
Clinical trial: NCT04947150
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: Could Being In **This Research Hurt Me?**|Will It Cost Me Money To Take Part In This Research?|Will Being In This Research Benefit Me?

Participation in this research study includes minimal risk. During this study, you will be encouraged to change your food purchasing behavior which may cause weight loss as a result of dietary change. If you are taking any medication you should carefully coordinate the oversight of these medications with your primary care physicians to make any necessary adjustments of dosage necessary if weight loss occurs. There may also be psychological risks to you such as feelings of shame or embarrassment related to eating habits, however, your coach will be trained to deliver the program in a way that feels positive to you. Lastly, there is always a risk for loss of privacy and confidentiality, though the research team will take many precautions to protect against this. Participation in the study may involve unforeseen risks. If unforeseen risks are seen, they will be reported to the Drexel Office of Regulatory Research Compliance.

You are responsible for the cost of any smartphone data use incurred from using the program app. There is no cost to you for downloading this program app.

We cannot promise any direct benefits to you or others from your taking part in this research. However, possible benefits to you include reduced risk of cancer incidence due to dietary change. Improving dietary quality also can improve other aspects of health and quality of life. It is also possible that clinically significant weight loss will occur along with dietary change, which is an additional medical benefit.
Clinical trial: NCT04947150
Section: Procedures
Subsections: What Happens To Me If I Agree To Take Part In This Research?

The study will require participation in a group-based, interactive, nutrition education workshop, delivered via Zoom. Content will be focused on eating a diet consistent with the World Cancer Research Fund/American Institute for Cancer Research (WCRF/AICR) guidelines: 1) eat a diet rich in whole grains/vegetables/fruit; 2) limit consumption of highly processed foods; 3) limit consumption of red meat and processed meat; and 4) limit consumption of sugar sweetened drinks. Following the workshop, you will receive at least one message per week for a period of 20 weeks (or 4 weeks if you are enrolled in pilot testing) that provide recommendations and reminders for food purchasing. You will be required to download the program app to your smartphone for the duration of the study to receive these message notifications. Your food purchasing will be monitored via your respective grocery store's loyalty program, in order to assess change over time. You will be randomly placed in 1 of 16 conditions. Neither you nor the study investigator will choose your study condition. Every participant receives at least three workshop sessions (90 min each) and weekly messages. Based on your condition assignment, you may also receive the following:  
  
 Protocol 2003007695A003 Approval Date: *03/25/2021*
- Someone will explain this research to you.  
- This form sums up that explanation.  
- Taking part in this research is voluntary. Whether you take part is up to you. - You can choose not to take part. There will be no penalty or loss of benefits to which you are otherwise entitled.  
- You can agree to take part and later change your mind. There will be no penalty or loss of benefits to which you are otherwise entitled.  
- If you don't understand, ask questions.  
- Ask all the questions you want before you decide. - Half of participants will receive one additional workshop session (approximately 60 min)  
  
designed to further enhance motivation for dietary change, along with one extra motivational message per week and three phone calls (20 min each) with a behavioral coach to discuss benefits of dietary change.  
- Half of participants will receive one additional workshop session (approximately 60 min)
along with an adult household member, in order to increase support for dietary change. This household member will receive weekly messages and the participant and household member will complete three phone calls (20 min each) together with a behavioral coach.  
- Half of participants will have a coach who monitors food purchases and provides personalized feedback in one extra message each week plus three phone calls (20 min each).  
- Half of participants will use the study app in a way that tracks location, so that messages can be delivered when arriving at a grocery store.  
In summary, you will receive either 3, 4, or 5 workshop sessions; 1, 2, or 3 weekly messages from the app; and 0, 3, 6, or 9 brief coaching phone calls. Remote assessments will be completed at 0, 10, and 20 weeks (or weeks 0 and 4 if you are enrolled in pilot testing). The first assessment, at week 0, will consist of a one-on-one, 30-60 minute Zoom session with an accessor in which you will be oriented to the study and be asked to complete a series of questionnaires. The week 10 assessment requires completion of self-report questionnaires (you will not complete a mid-treatment assessment if you are enrolled in pilot testing). The final assessment, at week 20 (or week 4 if you are enrolled in pilot testing), will require the completion of questionnaires and participation in a focus group (held via Zoom) in which you and other participants will reflect on your experience with the study and provide study investigators with relevant feedback.
Clinical trial: NCT04947150
Section: Purpose of Research
Subsections: Consent To Take Part In A Research Study|What Should I Know About This Research?

You are being invited to take part in a research study. A person who takes part in a research  
  
 study is called a research subject, or research participant.

Why Is This Research Being Done?  
The purpose of this research is to examine the utility of a remotely delivered mHealth intervention on modifying dietary intake for cancer prevention. 84 subjects (20 during pilot testing and 64 during experimental phase) will take part in this research.
Clinical trial: NCT04947150
Section: Voluntary Participation
Subsections: Will I Be Paid For Taking Part In This Research?

For taking part in this research, you may be paid up to a total of $180 (or $150 if you are enrolled in pilot testing) in the form of e-gift cards (Target or Amazon, your choice) or direct ACH payments to your bank account. ACH is a very common, secure and fast electronic payment method used by all major banks. The use of ACH as a payment option allows for remote payment and helps us protect the privacy and safety of the participants and the research staff. To use this form of payment, we will provide JPMorgan Chase Bank your study ID, name, and email or phone number. Chase will then send you an invitation to receive payment either as an email or a text message. Once you accept the invitation the funds will be deposited to your bank account. Drexel University and the research team do not have any access to your account information, and they are not directly involved in the disbursement of the funds.  
- You will be paid $75 for completing the 0-week assessment. In order to receive full payment for this assessment, you must complete 3 separate ASA-24 questionnaires ($20 each) and other measurements ($15).  
- You will be paid $30 for completing the 10-week assessment. Participants enrolled in pilot testing will not complete a mid-treatment assessment. Therefore, if you are enrolled in pilot testing, you are not eligible for this compensation.  
- You will be paid $75 for completing the 20-week assessment (or 4-week assessment if you are enrolled in pilot testing). In order to receive full payment for this assessment, you must complete 3 separate ASA-24 questionnaires ($20 each) and other measurements ($15).  
- If you choose to stop participating in the study, your compensation will be determined by the amount of participation you completed and, if you do not complete the study, the reason for leaving the study early.  
Federal tax law requires to you to report this payment as income to the Internal Revenue Service if you are compensated more than $599.00 (in total) this year for participating in research. You may be asked to tell us your social security number or other identifying information (e.g., full name). If payments for this study are more than $599.00, we will report them to the Internal Revenue Service and send you a Form 1099-MISC. This information will not be associated with the information or data you provide for this research. It will be stored separately from your data, it will not be linked in any way, and your identifying information will be destroyed within 1 year of study completion.
Clinical trial: NCT04947150
Section: Withdrawal from Study
Subsections: Can I Be Removed From This Research Without My Approval?|What Happens If I Agree To Be In This Research, **But I Change My Mind Later?**

The person in charge of this research can remove you from this research without your approval. Possible reasons for removal include:  
- If there is a change in your medical condition. - If the study is discontinued for any reason by the sponsor, investigator, university authorities, or government agencies.  
- If new information is available to the investigator. - If there are harmful unforeseen reactions experienced by you or other participants in the study.
We will tell you about any new information that may affect your health, welfare, or choice to stay in this research.

You can agree to take part in the research now and stop at any time. Participation in this study is voluntary, and you can refuse to be in the study or stop at any time. Any fee you may be paid will be determined by the amount of participation you completed and, if you do not complete the study, the reason for leaving the study early. If you stop being in the research, already collected data may not be removed from the study database.  
 Protocol 2003007695A003 Approval Date: *03/25/2021*