APPENDIX A

Pre-Enrollment Interview Script via Phone or Email

Hello, how are you? My name is Brittany Yates. I am conducting research for my Master’s Thesis on the energy cost of a new interactive video game. The study will take about 4 hours, in four separate sessions (Session 1 will last approximately 90 minutes and Sessions 2- 4 will last approximately 45 minutes), over a three week period, and involve measuring your maximal exercise capacity, and then measuring your energy expenditure during different phases of the video game. Would you be interested in participating?

NO, Thank you for contacting me. Good bye.

YES, That is great! Now, I have three questions for you to ensure you qualify for participation in this study.

1. Are you between the ages 18 and 24? YES, proceed to question 2

NO, thank you for your interest, but you are not eligible for participation in this study 2. Do you regularly participate in physical activity – 3 or more days a week for 30 minutes or longer each session?

Yes, for men, proceed to scheduling an appointment to sign consent forms and health screening

Yes, for women, proceed to question 3

No, thank you for your interest, but you are not eligible for participation in this study 3. For women: Are you pregnant, or planning to become pregnant in the next month?

No, proceed to scheduling an appointment to sign consent forms and health screening Yes, thank you for your interest, but you are not eligible for participation in this study

36 APPENDIX B Informed Consent University of North Carolina-Chapel Hill

Consent to Participate in a Research Study Adult Subjects

Biomedical Form IRB Study #07-1859

Consent Form Version Date: 11/07/2007

Title of Study: A Pilot Study on Energy Expenditure and Interactive Video Game Play Principal Investigator: Brittany E. Yates

UNC-Chapel Hill Department: Exercise and Sport Science UNC-Chapel Hill Phone number: (757) 439-0893

Email Address: [email protected] Faculty Advisor: Robert G. McMurray, Ph.D. Funding Source: None

Study Contact telephone number: (757) 439-0893 Study Contact email: [email protected]

What are some general things you should know about research studies?

You are being asked to take part in a research study. To join the study is voluntary. You may refuse to join, or you may withdraw your consent to be in the study, for any reason. Research studies are designed to obtain new knowledge that may help other people in the future. You may not receive any direct benefit from being in the research study. There also may be risks to being in research studies.

Deciding not to be in the study or leaving the study before it is done will not affect your relationship with the researcher, your health care provider, or the University of North Carolina-Chapel Hill. If you are a patient with an illness, you do not have to be in the research study in order to receive health care.

Details about this study are discussed below. It is important that you understand this information so that you can make an informed choice about being in this research study. You will be given a copy of this consent form. You should ask the researchers named above, or staff members who may assist them, any questions you have about this study at any time.

What is the purpose of this study?

Interactive video games have the potential to increase physical activity levels, which could result in the reduction of cardiovascular disease risk factors and also promote weight loss. However, we know nothing about the energy expenditure to the game, Yourself!FitnessTM. The purpose of this investigation is to determine the energy expenditure and heart rate responses to participation in the “Yourself!FitnessTM,” interactive fitness video game. Of particular interest, this study will investigate differences in the manufacturer’s game- predicted and measured caloric expenditure for both the Cardio and Weight Loss gaming modes. Additional comparisons will be made for caloric expenditure between the Cardio and Weight Loss modes between college age males and females.

Research in this area is significant because obesity is on the rise. Therefore, it is of paramount importance to explore other venues for promoting physical exercise. Activity- promoting video games could become potent tools for weight management and potentially reversing sedentary behaviors while permitting highly valued screen-based activities. It has not yet been determined, whether Yourself!FitnessTM is effective in increasing energy expenditure equivalent to moderate and/or vigorous intensity physical activity. The

knowledge gained through research using Yourself!FitnessTM will help exercise physiologists determine if video game play can be a viable means for physical activity.

You are being asked to be in the study because you are between the ages of 18 and 24 and are physically active 3 or more days a week for 30 minutes or longer during each session.

Are there any reasons you should not be in this study?

You should not be in this study if you have a history of heart disease, uncontrolled diabetes, hypertension, pulmonary disease, severe arthritis, extreme overweight, pregnancy, major orthopedic maladies, or any other condition that could place you at risk during exercise. For Females Only: If you are currently pregnant, or become pregnant during the study, you should not participate in this study because the exercise intensity and duration may be greater than what is recommended by the American College of Obstetricians and Gynecologists (ACOG).

How many people will take part in this study?

If you decide to be in this study, you will be one of approximately 20 people in this research study.

How long will your part in this study last?

You will participate in a total of 4 testing sessions. The initial testing session will be no longer than 90 minutes, while the remaining sessions will last no more than 1 hour. Each participant will complete all four trials within 3 weeks of beginning the study so that changes in training status do not become a factor. You will complete all four trials at the same time of day with at least 24 hours rest between trials.

38 What will happen if you take part in the study? Trial 1

During the first visit, the study procedures will be explained to you and you will be given the opportunity to ask and have your questions answered prior to providing written consent. Once consent has been given, you will complete the medical history, and be given a pre- participation physical exam. After the physical exam, height and weight will be measured. You will then complete a graded exercise test at this time.

The graded exercise test will be completed on a treadmill using a modified using a protocol that consists of increases in speed from 3 to 6 miles per hour every 2 minutes. After 8 minutes of exercise, speed was held constant at 6 miles per hour, while grade was increased 5% every 2 minutes until the subject signaled volitional fatigue. Heart rate will be

continuously monitored by hear rate monitor and recorded in the last 10 seconds of each stage. A breathing valve with nose clips will be used to measure metabolic rate during every minute of the test. Rate of perceived exertion (RPE) will be measured at the end of every stage. You will be monitored at the conclusion of the exercise test until heart rate reaches 120 beats per minute or less.

Trial 2

You will complete the Yourself!FitnessTM personal profile during your second visit. A portable system that measures metabolic rate and a heart rate sensing chest strap will be worn during this session to allow for familiarization, however no data will be recorded. The first screen of the personal profile requires you to enter your “name,” in the form of the subject ID number, gender, and height. You will then indicate that no equipment will be used in the second screen of the personal profile. You will then complete the virtual fitness evaluation. During the fitness evaluation, you are first requested to enter your weight. The video game will then instruct you how to measure and record your resting heart rate. Next, you will complete a two minute jumping jack evaluation following the on-screen animated body model. At the conclusion of the jumping jack evaluation the video game will once again prompt you to measure and record your exercise heart rate. You will also indicate your current level of activity over the past six months. You will once again, follow the on-screen animated body model to complete body weight squats, pushups, crunches, and sit and reach. Lastly, you will select the Yourself!FitnessTM suggested goal focus for their program. The commitment schedule and meal plan aspects of the video game will not be taken into consideration for this study; therefore game defaults will be used.

Trials 3 and 4

You will perform the Weight Loss (WL) or Cardio (CV) gaming modes of

Yourself!FitnessTM. The modes will be randomly assigned for the next two trials. You will also be blinded with respect to gaming mode, in that you will receive no knowledge of the WL or CV mode you will perform for each trial. You should not exercise or consume caffeine three hours prior to testing and arrive at the laboratory no sooner than four hours after eating.

Weight Loss Gaming Mode (WL)

The video game will prompt you to respond to the initial perceived exertion question of, “How are you?” You will select “Not too bad.” The WL workout will be 30 minutes in length including a 3 minute warm-up and a 2 minute cool-down. Maya, the

Yourself!FitnessTM virtual personal trainer, will lead you through the workout.

During the WL workout, the portable metabolic system and heart rate sensing chest strap will be continuously worn throughout the duration of the exercise bout. The system will be used to measure respiratory gases and heart rate every minute during the trial. The video game will prompt you several times throughout the duration of the workout to respond to the perceived exertion question, “How did you feel about that?” You will respond, “I was working hard.” Yourself!FitnessTM will report the calories expended during that exercise session at the end of the workout. This value will be recorded for further comparison. Heart rate and blood pressure will be monitored after the exercise bout until your heart rate is less than 120 beats per minute (bpm) and/or your blood pressure returns to resting levels. At that time, if you respond that you are OK, the person will be released on their own recognizant. Cardio Gaming Mode (CV)

The CV workout will be 30 minutes in length including a 3 minute warm-up and a 2 minute cool-down. Again, Maya, the Yourself!FitnessTM virtual personal trainer, will lead you through the workout. Perceived exertion prompts prior to exercise and during will follow the same format as the WL trial. Measurements during the CV trial will be recorded using the same equipment and time intervals as used in the WL trial.

Please note that some individuals may not be eligible for participation based on the outcome of baseline testing (i.e. medical history, physical exam, or EKG). If it is determined that you will not be eligible for participation in this study due to findings during baseline testing you will be referred to your primary care physician, Student Health, or in extreme cases, UNC Hospitals.

What are the possible benefits from being in this study?

Research is designed to benefit society by gaining new knowledge. You will benefit from participation in this study in that you will learn your cardiorespiratory fitness (VO2max) and

you may also obtain a copy of your pre-test electrocardiogram (EKG).

What are the possible risks or discomforts involved with being in this study? There should be no risk of psychosocial harm, economic harm, or legal jeopardy. Medications will not be used in this study; therefore, there is no risk of drug-related side- effects.

There are risks associated with participation in this study, such as: fatigue, muscle soreness, sprain, strain, and/or broken bones. These are minimal, but do exist. Risks are minimized by proper warm-up and cool-down as well as continuous prompting by the video game to ensure exercise intensity is appropriate. It is unlikely, but you may experience chest pain, dizziness, fainting, abnormal heart rhythms or even a heart attack. Although rare, sudden death has been reported during strenuous exercise, even in highly trained athletes.

40

Although no radioactive materials are being used for this study, the UNC Chapel Hill Applied Physiology Laboratory, where you will be performing exercise tests, houses radioactive materials. The amount of radioactive material is very small and should pose no health threat to subjects. All radioactive material is stored in a contained biochemistry

section of the Applied Physiology Laboratory, and is kept in compliance with all UNC Office of Environmental, Health & Safety regulations.

In addition, there may be uncommon or previously unknown risks that might occur. You should report any problems to the researchers.

What are the risks to a pregnancy or to a nursing child?

If you are a woman and you are planning to get pregnant, you should not be in the study. The exercise intensity and duration of exercise in this study may be greater than what is recommended by the American College of Obstetricians and Gynecologists (ACOG). How will your privacy be protected?

No subjects will be identified in any report or publication about this study. Although every effort will be made to keep research records private, there may be times when federal or state law requires the disclosure of such records, including personal information. This is very unlikely, but if disclosure is ever required, UNC-Chapel Hill will take steps allowable by law to protect the privacy of personal information. In some cases, your information in this research study could be reviewed by representatives of the University, research sponsors, or government agencies for purposes such as quality control or safety.

Upon agreement to participate in the study, you will receive a participation number, and be referred to by that number at all times during the study. Any electronic files containing information linking subjects to their respective participation number will be in a password protected document on a password protected computer. Only my faculty adviser and I will have access to this information. Data collected throughout the duration of the study will be stored in a locked file cabinet in the Applied Physiology Lab. Once you have participation in the study, all information linking you to participation in this study will be destroyed.

What will happen if you are injured by this research?

All research involves a chance that something bad might happen to you. This may include the risk of personal injury. In spite of all safety measures, you might develop a reaction or injury from being in this study. If such problems occur, the researchers will help you get medical care, but any costs for the medical care will be billed to you and/or your insurance company. The University of North Carolina at Chapel Hill has not set aside funds to pay you for any such reactions or injuries, or for the related medical care. However, by signing this form, you do not give up any of your legal rights.

What if you want to stop before your part in the study is complete?

You can withdraw from this study at any time, without penalty. The investigators also have the right to stop your participation at any time. This could be because you have had an unexpected reaction, or have failed to follow instructions, or because the entire study has been stopped.

Will you receive anything for being in this study?

You will be receiving data on your cardiorespiratory fitness (VO2max) and a copy of your

pre-test electrocardiogram (EKG) for taking part in this study. Will it cost you anything to be in this study?

It will not cost you anything to participate in this study. You will be responsible for paying for transportation and parking costs, if necessary.

What if you are a UNC student?

You may choose not to be in the study or to stop being in the study before it is over at any time. This will not affect your class standing or grades at UNC-Chapel Hill. You will not be offered or receive any special consideration if you take part in this research.

What if you are a UNC employee?

Taking part in this research is not a part of your University duties, and refusing will not affect your job. You will not be offered or receive any special job-related consideration if you take part in this research.

Who is sponsoring this study?

This research is not funded by any outside resources. What if you have questions about this study?

You have the right to ask, and have answered, any questions you may have about this research. If you have questions, or if a research-related injury occurs, you should contact the researchers listed on the first page of this form.

What if you have questions about your rights as a research subject?

All research on human volunteers is reviewed by a committee that works to protect your rights and welfare. If you have questions or concerns about your rights as a research subject you may contact, anonymously if you wish, the Institutional Review Board at 919-966-3113 or by email to [email protected].

- - - Subject’s Agreement:

I have read the information provided above. I have asked all the questions I have at this time. I voluntarily agree to participate in this research study.

_________________________________________ _________________

Signature of Research Subject Date

Printed Name of Research Subject

_________________________________________ _________________ Signature of Person Obtaining Consent Date

42 APPENDIX C Data Collection Forms

Energy Expenditure and Video Games Subject __________

Trial 1 Date:_________ Time:_________