Research Ethics Board

The acute effects of protein intake on the regulation of ghrelin and insulin in children with Prader-Willi Syndrome compared to controls.

Principal Investigator: Andrea Haqq, MD, MHS, FRCP(C)

INFORMATION LETTER

Note: The pronouns ‘you’ and ‘your’ should be read as referring to the participant (your child) rather than the person who is signing the consent for the participant.

Background: Prader-Willi Syndrome (PWS) is a genetic disorder. Children with PWS typically have a higher body weight than normal. However, the factors that influence appetite and weight gain in children with PWS are not completely understood and may be different from children without the syndrome.

Purpose: The purpose of this study is to examine dietary intake of children with PWS and to compare their intake to children without the syndrome. Although you do not have PWS, you are being asked to participate in this study because we would like to compare the results to children without the syndrome. Your participation in this study can be completed at home. It will take approximately 3 hours of your time, spread out over six days (~30 minutes per day). Procedures: A participation package will be mail to you. Upon receiving this package, study staff will contact you to discuss the study with you and your parent or legal guardian. If you both agree, we will ask your parent/legal guardian to sign this form. We will then ask you to record your height, weight, age and gender. Included in the participation package will be two 3-day food record booklets which contain instructions. Study staff will go through these instructions with you in detail. You will be asked to keep a record of everything you eat and drink for three days on two separate occasions. The booklet contains space to write what you ate and drank each day. You will also be asked about your level of activity on each of the three days. Once you have completed both booklets, you will mail all study forms back to our research team in the self-addressed stamped envelope provided.

Possible Benefits: Participation in this study may or may not be of personal benefit to you. However, the study could provide information that benefits patients with or without PWS in the future.

Possible Risks: There are no possible risks to participating in this study.

Confidentiality: Any research data collected about you during this study will not identify you by name, only by a coded number. Any report published as a result of this study will not identify you by name.

Voluntary Participation: You are free to withdraw from the research study at any time, and your continuing medical care will not be affected in any way. If the study is not undertaken or if it is discontinued at any time, the quality of your medical care will not be affected. You may withdraw your consent for us to use data that has already been collected (other than data needed to keep track of your withdrawal).

Control: Version: February 20, 2014 Contact Names and Telephone Numbers: If you have concerns about your rights as a study participant, you may contact the Research Ethics Office at (780) 492-2615. This office has no affiliation with the study investigators.

Please contact any of the individuals identified below if you have any questions or concerns: Dr. Andrea Haqq, Principal Investigator (780) 248-5488 or (780) 938-3474 Sarah Loehr, Study Coordinator (780) 248-5481

Control: Version: February 20, 2014 PARENT CONSENT FORM

Title of Project:The acute effects of protein intake on the regulation of ghrelin and insulin in children with Prader-Willi Syndrome compared to controls.

Principal Investigator: Andrea Haqq, MD, MHS, FRCP(C) Phone Number: (780) 248-5488 Study Coordinator: Sarah Loehr, MSc Phone Number: (780) 248-5481 ______

Part 2 (to be completed by the parent/guardian of the research subject): Yes No Do you understand that your child has been asked to participate in a research study?   Have you read and received a copy of the attached Information Sheet?   Do you understand the benefits and risks involved in taking part in this research study?   Have you had an opportunity to ask questions and discuss this study?   Do you understand that you are free to withdraw your child from the study at any time, without having to give a reason and without affecting your child's future medical care?   Do you want the investigator(s) to inform your child's family doctor or pediatrician that your child is participating in this research study? Doctor’s name   Who explained this study to you? ______

Child’s Name ______

I agree for my child to take part in this study: YES  NO  Signature of Parent or Guardian ______Date & Time ______

(Printed Name) ______

Signature of Witness ______Date & Time ______

Signature of Investigator or Designee ______Date & Time ______

THE INFORMATION SHEET MUST BE ATTACHED TO THIS CONSENT FORM AND A COPY GIVEN TO THE RESEARCH SUBJECT

Version: February 20, 2014