Attach 3 - Invite Letter

Attachment 3: Invitation Letter for the 24HR Recall Comparison Study

Diet Methods Study Invitation Letter

(On Health Center Letterhead)

Name:

Address:

Dear _______________________:

(Health center) and the National Institutes of Health invite you to take part in an important short-term study. This study is aimed at learning how best to collect information on food intake of Americans. The results will enable researchers to design better studies that will ultimately increase our understanding of diet and disease.

What do you have to do?

• You’ll tell us about your food intake on two different days.

• You’ll give us some information about yourself and your experience with the study.

• You’ll complete the interviews in your home and you don’t have to go anywhere.

Why were you chosen?

We will be enrolling participants from your center. Your name was chosen randomly from all the eligible people from your center. This is why it’s very important that you participate and complete the study.

Where can you get additional information about the study?

For more information about the study, see the list of Frequently Asked Questions on the back of this letter. You can also call (name), title, at (phone number).

How do you sign up?

To sign up, go to (website name) and complete the on-line form. You will be contacted by telephone in the next week to confirm your participation and to answer any questions you may have.

As a token of our gratitude, you will receive up to an additional $50 for your participation.

We hope you will join us in this important study. It is only with the generous help of people like you that our project can be successful.

Thank you!

Health center staff signature and date

NCI staff signature and date

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 the 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: 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 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: Will my insurance be affected?

A: No. Your responses will not affect your health insurance coverage, premium costs, or relationship with your health insurance 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. This study has been approved by the Office of Management and Budget (OMB), the office that reviews all federally-sponsored surveys. The OMB approval number assigned to this study is _______________.

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 ___________________________.