APPENDIX D. PARENT INFORMATION AND CONSENT FORM

Title of Research Study: Individual, Interpersonal and Organizational Determinants of Children's Physical Activity at Childcare

This study is being conducted by: Dr. Abby Gold [email protected] and Michelle Strang [email protected] from the Department of Public Health and North Dakota State University (NDSU).

Why is my child being asked to take part in this research study? Your child is invited to participate in a research study to evaluate preschoolers’ physical activity patterns while at childcare. Your child has been selected because he/she is between the ages of 3 and 5, and attends (full time) a licensed childcare facility that has agreed to participate in this study. Similar centers throughout Fargo, Moorhead, West Fargo and the surrounding areas have also been invited to participate.

What is the reason for doing the study? There are two main goals of this project: 1) to measure how much physical activity children are getting at childcare, and 2) to examine factors within the childcare center (center size, play space, teachers’ actions, etc.) that may influence children’s activity. Results from this research will be used to create a “best practices” guideline that childcare centers can use to help children learn and adopt healthy behaviors early in life.

What will my child be asked to do? We will not try to change your child’s normal routine at childcare. To measure your child’s activity, we will ask him/her to wear a small piece of equipment (called an accelerometer) on an elastic belt around their waist while at childcare. In addition, we will measure and weigh your child in a private location with help from his/her classroom teacher. The study will be done over a three-day period and will be supervised by childcare staff. We will explain carefully to your child that the accelerometer helps us measure how they move and play during the day, and the height and weight measurements will help to see how they are growing.

Accelerometers are small devices which sense and record movement. The accelerometers cannot be broken and do not have moving parts. Accelerometers are attached to an elastic waistband that is worn on the outside of clothing, and will not touch the child’s skin. Each accelerometer is protected in a soft plastic case.

At the beginning of each day during the study, your child will be fit with an accelerometer when he/she arrives at the childcare center. Your child will always be asked whether or not he/she wishes to participate in the study by wearing the accelerometer. The accelerometer will be removed at naptime. Upon waking, your child will be asked again if he/she wishes to continue participating in the study by wearing the accelerometer. Children who wish to continue will be re-fit with the accelerometer. If at any time your child indicates that he/she does not want to wear the accelerometer, it will be removed. At the end of the day, the accelerometer will be removed by your child’s teacher and stored at the center.

Finally, if you decide to allow your child to participate in this study, you will be asked to fill out a short (4 question) survey asking about your child’s age, gender, ethnicity, and your level of education.

Where is the study going to take place, and how long will it take? The study will take place at your child’s childcare center for three consecutive days. Again, we are simply measuring the duration and intensity of children’s physical activity. We will not disrupt the normal schedule other than to weigh and measure participants on the first day of the study.

What are the risks and discomforts? There is no known health or injury risks associated with wearing an accelerometer, besides falling directly onto the device. Such a fall may cause

localized swelling, bruising, or discomfort. However, the risk of such an injury from falling directly on top of the accelerometer is no greater than the risk of falling on a toy that is being carried or laying on the ground.

In addition, as a parent/guardian of a participating child you do not need to worry about your child damaging the accelerometer. The accelerometer is contained within its own protective case made of durable plastic. If an accelerometer is damaged by a participant, you will not be held liable for that damage and will not be expected to pay for any costs associated with repairing or replacing the device.

Are their benefits to my child? Your child is not expected to receive any direct benefit from being in this research study. However, we will provide you with a summary of the amount of time your child spent participating in different types of physical activity during the three day study, if you wish.

What are the benefits to other people? We will also provide your child’s daycare center with an overall summary (not each child separately) of the amount of physical activity that children got during the evaluation. More importantly, we will use the results of this study to create a best practices guideline, which will highlight the most effective ways to increase children’s activity levels while at daycare. As a token of thanks, your child’s daycare center will receive a $100 gift card to purchase activity-promoting materials, and your child’s teacher will receive a $50 gift card.

Does my child have to participate in the study? Your child’s participation is voluntary and he/she may quit at any time. Your decision to allow your child to participate will not affect your or your child’s ability to attend the childcare center or any other benefits to which they are otherwise entitled.

What are the alternatives to being in this research study? If your child does not participate in this research, their normal routine will not be altered in any way

Who will have access to my child’s information?

We will keep private all research records that identify your child. Your child’s information will be combined with information from other people taking part in the study. When we write about the study, we will write about the combined information that we have gathered. We may publish

the results of the study; however, we will keep your child’s name and other identifying information private.

Data and records from this project are owned by North Dakota State University and the

investigator. You may view information collected from your child by making a written request to the principal investigator. You may view only information collected from your child, and not information collected about other children participating in the project.

Can my child’s participation in the study end early? If you decide to allow your child to participate, you are free to withdraw your permission and to discontinue their participation at any time. Furthermore, if you decide to allow your child to participate, he/she still has the final say as to whether or not he/she wants to participate. Your child will be asked whether he/she wants to participate in the study at the beginning of each day and several times throughout the day. If at any time your child indicates that he/she does not want to wear the accelerometer or participate in the study, it will be removed by a member of the childcare staff.

What if I have questions?

Before you decide whether to accept this invitation to let your child participate in the research study, please ask any questions you may have by contacting the researchers, Dr. Abby Gold at [email protected] or 231-7478, or Michelle Strang at [email protected] or 701-241-5881. If at any time during or after the study you have more questions, please feel free to ask.

What are my child’s rights as a research participant?

Your child has rights as a participant in research. If you have questions about your child’s rights or complaints about this research, you may talk to the researchers or contact the NDSU Human Research Protection Program by:

 Telephone: 701.231.8995 or toll-free 1.855.800.6717

 Email: [email protected]

 Mail: NDSU HRPP Office, NDSU Dept. 4000, PO Box 6050, Fargo, ND 58108-6050.

The role of the Human Research Protection Program is to see that your rights are protected in this research; more information about your rights can be found at: www.ndsu.edu/irb . Documentation of Informed Consent:

You are freely making a decision whether to be in this research study. Signing this form means that

7. you have read and understood this consent form 8. you have had your questions answered, and

9. you give your permission for your child to be in the study.

You will be given a copy of this form to keep.

Your signature Date

Your printed name

Your Child’s Name

Signature of researcher explaining study Date

Printed name of researcher explaining study