Form 1 Comparison Study Screenshot Information and Consent

Attachment 2: Screenshots of 24HR Recall Comparison Study Information and Consent

SCREEN 1

Welcome to the Diet Methods Study

We invite you to take part in the Diet Methods Study, being conducted by your health center and the National Institutes of Health. Your participation in this short-term important study will help us understand how best to ask about what people are eating.

We are testing two methods for collecting food intake information

1. Telephone survey, and

2. Computer survey.

SCREEN 2

What will you have to do?

• Two surveys about your food intake (30 minutes each time).

• One survey about yourself and your health (5 -10 minutes).

• For some of you, one survey about your experience in providing food information (2 – 3 minutes).

What’s in it for you?

• Satisfaction in contributing to research that will be used in future studies of diet and health.

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Frequently Asked Questions

Q: What is the Diet Methods Study?

A: The study will collect information about what people eat, using a telephone and a computer. All participants have to have access to high speed internet. People from three different health centers, including yours, are being asked to join this study.

Q: How will the study results be used?

A: The results of this study will allow researchers to compare different ways to collect information about foods eaten and improve these methods. The new, improved methods will allow future studies to understand diet and health better.

Q: Why was I chosen?

A: Your health center identified individuals who have used the center’s internet services, and you were selected at random to be a part of this study. If you agree to participate, you will be asked to share your telephone number(s) with our study staff, at Westat, the study contractor. However, this will be kept confidential and will not be given to anyone else. If your number is unlisted, it will remain unlisted.

Q: Why should I take part in this study? Do I have to do this?

A: Your participation will move forward our understanding of how to improve dietary reports. Future studies will benefit by having more accurate dietary information. Your participation is voluntary, and you may refuse to answer any questions or withdraw from the study at any time. Your answers and opinions are very important to the success of this study, as you represent others who share your knowledge and beliefs.

Q: What information will be collected from me?

A: You will provide information about your food intake, by telephone or computer. This will be done twice, once in the near future and then again, four to six weeks later. You will be asked to answer some questions about your health and health behaviors, and your characteristics, like your age. If you use both the telephone and the computer to report your foods eaten, you will also complete a survey about how well those tools worked for you.

Q: Who will see my answers? Will my information be kept confidential?

A: No one will see your individual answers. Your responses will be given a code number and will not include your name, phone number or any other personal information. All names and identifying information will be removed before data are sent to study researchers. Your answers will be grouped with those of other people who take the survey. Overall, about 1000 people will be in this study. Reports of results will not include your name or any other information that could personally identify you.

Q: Who are the researchers?

A: Researchers include scientists from the National Institutes of Health and the three health centers taking part in the study, Security Health Plan (using the Marshfield Clinic), Wisconsin; Henry Ford Health System, Michigan; and Northern California Kaiser-Permanente, California. The study will be managed by Westat, a private research company in Rockville, MD.

Q: Will I be paid for doing this study? How much?

A: You have received $2 as a token of good will. If you are eligible for the study and choose to participate, you will receive $5. After you report your foods eaten the first time, you will receive $15. And after you report your foods eaten the second time, and answer the other questions described earlier, you will receive $30.

Q: Are there any costs to me to take part in the study?

A: No. You will be answering all the questions in the study by telephone and on the computer.

Q: How will I benefit from participation in the project?

A: You may take satisfaction in helping the National Institutes of Health in their goal of improving the health of Americans.

Q: Will my insurance be affected?

A: No. Your responses will not affect your health insurance coverage, premium costs, or relationship with your health provider in any way.

Q: Why is my health plan involved in this study?

A: This project will help the National Institutes of Health to improve the methods for best asking about what people eat. Your health plan and the National Institutes of Health are committed to improving the health of all Americans. The study is not funded by insurance premium dollars. It is paid for by the National Institutes of Health.

Q: Is this study approved by the Federal Government?

A: Yes. The study has been approved by the Office of Management and Budget (OMB), the office that reviews all federally-sponsored surveys. The study also has been reviewed and approved by committees that protect human subjects in research at your health center and the National Institutes of Health.

Q: If I use my computer in this study, will I be getting more spam? What about viruses, and ID theft?

A: No. All your interactions on your computer will be on a secure website. No other parties will be able to access you through this secure website.

Q: Who do I call if I have questions?

A: You may call the research contractor Westat toll-free at _______________ Monday-Friday 8:00 am-11:00 pm; Saturday 11:00 am-5:00 pm; Sunday 1:00-9:00 pm. Or you may call your center’s Principal Investigator, (PI at health center) at or your human subjects’ protection contact person, (IRB contact at health center) at __________________________________________.

SCREEN 4

Do you agree to participate in this important study?

To protect your confidentiality, there are some things you should know before you take part in the Diet Methods Study:

• Your participation is voluntary.

• Your health benefits will not be affected if you choose to not participate.

• You may stop your participation in the project at any time.

Participation in the study involves providing food intake information on two days. To protect your privacy:

• Information is collected from a "secure" https server and your responses cannot be seen by unauthorized third parties (e.g., computer hackers).

• All responses will be kept confidential. Each participant will be given an ID number, and only your health plan will have the link of the ID to your name. All information will be combined and published without any identifying information and as grouped data only.

If you have any questions about this study or your rights as a participant, you may call _________________ (Westat ), toll-free at _________________. Or you may call your center’s Principal Investigator (name and phone number), or your center’s institutional review board representative (name and phone number).

If you are 20 years of age or older, understand the statements above, and freely consent to participate in the study, click on the "I Agree" button.

I agree

I do not agree