Description of Study and Eligibility Questionnaire

Attachment 1: Study description and eligibility phone screening questionnaire

You’re being asked to participate in a comparison study conducted for a health study conducted by the Department of Health and Human Services. It has two parts: the Dual Energy X-Ray Absorptiometry or DXA study, and the Hematology Analyzer and Blood Tube study.

The DXA study will help us keep monitoring osteoporosis and body composition changes in the U.S. population. If you agree to take part, you will complete three DXA scans (whole body, spine, and femur) on two different machines , for a total of six DXA scans. We will compare the scans and readings from the two machines to see if there are differences. The scans are administered by trained, certified, and licensed health professionals. It should take approximately 45 minutes to complete.

The whole-body scan will measure how much body fat you have. The spine and femur scans will measure how strong your bones are. These scans involve low-dosage x-rays to people aged 20-70 years. Radiation exposure is equal to a cross-country airline flight or a few days of natural background radiation. However, because the bone density scan involves x-rays, those who are pregnant will not be scanned. Therefore, women of childbearing ages 20-59 years who wish to participate will receive a urine pregnancy test prior to the scans.

If you are eligible, participation is voluntary and you may choose to end your participation at any time without loss of benefits. You will still receive the $100 debit/gift card for your time as a token of appreciation.

First, we need to learn some information about you to find out if you’re eligible. As just discussed, you may choose not to answer any of these questions.

Eligibility questions for DXA scans:

1. How old are you?

2. What is your gender?

3. Are you pregnant? (females only) If yes, not eligible

4. How much do you weigh? (not eligible if the person weighs more than 450 pounds)

5. How tall are you? (not eligible if the person is taller than 6' 5")

6. In the past 7 days, have you had any x-ray or test with the use of contrast material, such as barium? If yes, not eligible

7. Do you have a Harrington rod (metal rod) in your spine for scoliosis? If yes, not eligible

8. Have you ever fractured your hip, had a hip replacement, or do you have a pin in your hip? If yes, which hip? For both left and right hip, not eligible

The second part of the study is the Hematology Analyzer and Blood Tube study. It will help us keep monitoring trends for nutritional biomarkers that may result in conditions such as anemia, and biomarkers for diabetes, kidney, liver, and heart disease. If you agree to take part, you’ll have a blood draw of approximately 1.8 tablespoons of blood, or 4 tubes, which will take approximately 10 minutes.

If you’re eligible, participation is voluntary, and you may choose to end your participation at any time without loss of benefits.

First, we need to learn some information about you to find out if you’re eligible.

Eligibility questions for hematology studies:

1. Do you have hemophilia?

2. Have you had cancer chemotherapy within the last 4 weeks?