Explanation of Procedures. To be included in the study, you must meet the following inclusion criteria:
Explanation of Procedures. If you take part in this study, you will allow a member of the study staff to go into your medical chart and record a list of the health problems you have (e.g., diabetes, high blood pressure) and the specific diagnosis that caused you to come to CR (e.g., a heart attack). This information will be kept in a confidential chart. If you choose to participate in this study, you will be asked to attend a baseline assessment visit at either the WCDRC or CR where you will complete questionnaires about your physical activity, eating behaviors, mood, health, and strategies you have used to lose weight as well as a demographic questionnaire. Some of these questionnaires will be on the computer, and some will be a pencil and paper survey. You will complete a very brief assessment of your cognition; this assessment feels like completing a few puzzles and word games. Your height and weight will also be measured. You will also wear an armband on your upper arm for one week during the majority of your daily activities. This armband will be sized to fit you comfortably. It tracks your physical activity while you are awake. It will not interfere with any devices in your body, particularly devices that affect your heart (e.g., implantable cardioverter defibrillator). All of the information that you provide or that is taken from your medical chart will be kept confidential. Please see Section 9 of this form for additional details on the ways the research staff will maintain your privacy. This first visit will take up to 90 minutes. You will be asked to return to the WCDRC or CR for an assessment visit 3 months into the 6-month treatment program, and again at the end of the 6-month treatment program. Alternatively, you may complete the assessments online via a secure link. In that case, you will need to either receive the armband in the mail and send it back to us, or pick it up and drop it off. Again, we will accommodate you based on your preference. At these assessment visits, you will again complete questionnaires and have your weight measured. You will also wear the armband for one week prior to these visits. We will mail the armband to you ahead of time, or you are welcome to meet a member of the research staff to pick it up if that is your preference. You will receive $25 for completing the 3-month visit, and you will receive $50 for completing the 6-month assessment visit. These two visits will take up to 75 minutes each. Free parking adjacent to the building is availa...
Explanation of Procedures. If you take part in this study, you will:
Explanation of Procedures. Participation will involve a screening conversation via telephone and mail to determine study eligibility. You have already completed this screening. If you and your child are eligible, you are now being asked to sign this consent form. This consent form and assent form for children will be explained to you by a member of the research team. Should you wish to participate, you and your child will be asked to sign these documents indicating your willingness to participate and complete an in-person interview and several questionnaires to further determine eligibility. If your child is eligible and you have agreed to participate, you will be asked to stay at the Weight Control and Diabetes Research Center for approximately 2 hours. You will receive a detailed study explanation, provide informed consent, complete study questionnaires, and be trained in how to complete cognitive tasks and questionnaires using a Web-based application (app) loaded onto a personal or study-loaned smartphone. You and your child will have their height and weight measured and complete assessments of eating behaviors, cognitive functioning, and psychiatric comorbidities. We would like to record the interview for training purposes, but you can decline to have them recorded. I GIVE THE RESEARCHERS PERMISSION TO AUDIO/VIDEORECORD THE INTERVIEWS WITH MY CHILD □ YES □ NO Signature of parent/guardian* Date and Time when signed Signature of parent/guardian* Date and Time when signed You will be given the opportunity to review the questionnaires before they are administered to your child, and to withdraw your consent for your child to complete any or all of the questionnaires if you choose. In addition, you or your child will be asked to complete a questionnaire which addresses how physically developed your child has become, in terms of the emergence and growth of hair around the genitals. This is called Xxxxxx staging, allowing the doctor and the researchers to understand at what point in physical growth towards an adult body a child or adolescent has reached. Eligible children will be asked to complete questionnaires and cognitive tasks on their personal smartphone or a study-loaned smartphone over the following 15 days. Your child will be prompted 3-5 times a day randomly to complete these questionnaires or tasks; however, these prompts will not interfere with the school day. The research team will work with each participant’s school schedule to ensure prompts are not timed during their spe...
Explanation of Procedures. Two sets of questions are needed to complete your part of this project. The first questions are included with this form. Students will also be contacted by telephone and asked more questions one year after leaving high school.
Explanation of Procedures. If you agree to take part in this study, you will first read and sign this consent form before any study procedures begin. This study has been designed to be a randomized cross-over trial. This means there will be 2 treatment periods in the study. “
Explanation of Procedures. If you participate in this study, you will receive a 4-month, Internet- based behavioral weight loss program followed by an 8-month, Internet-based weight loss maintenance program. As part of this program, you will be asked to view video lessons and log your calorie intake, weight, and physical activity on the study website weekly. In addition to the Internet program, some individuals will also receive phone coaching. You may be randomly assigned to either 3 weeks of phone coaching, 12 weeks of phone coaching, or no phone coaching. You cannot choose whether or not you receive the phone coaching, rather it is determined by a method similar to flipping a coin. It is estimated that approximately 50% of individuals will receive phone coaching. We will conduct assessments of weight, diet, physical activity, and various questionnaire measures at baseline, 4, and 12 months. More details regarding the internet program, phone coaching, and assessment visits can be found below. Internet-based weight loss and weight loss maintenance program – All individuals enrolled in this study will receive a 4-month Internet-based weight loss program followed by an 8-month Internet-based weight loss maintenance program. During the first 4 months, each week you will be asked to view a 10-15-minute multi-media lesson (one per week). These lessons focus on behavioral principles for changing your diet and physical activity behaviors. You will also be given weight loss, calorie intake, and physical activity goals. You will be taught how to self-monitor this information and be instructed to submit it weekly on the study website. After you submit this information, you will receive a weekly individualized feedback message. Following the 4-month weight loss program you will receive an 8-month weight loss maintenance program. During this time, you will be asked to view monthly video lessons which focus on strategies for successful WL maintenance and you will be instructed to continue to self-monitor your weight, calorie intake, and physical activity minutes on the study website for one week per month. Feedback will be provided based upon this data. Phone coaching – In addition to the Internet program described above, some individuals enrolled in this study will be selected to receive phone coaching. All calls will be audio recorded so that content from the session can be coded and analyzed for research and quality control purposes. Individuals will not be identified in any way and all info...
Explanation of Procedures. Your child will be randomly assigned (like by the flip of a coin) by a computer to one of two groups. Neither you nor the researcher can decide which group you will be assigned to. For both groups, this study will involve your child’s participation in a brief survey and in-person session here in the emergency department (ED), followed by text messages for 8 weeks. The in-person session will be conducted right now, before you leave the ED, and will take about 20-30 minutes. In the session, we will go over with your child either the way that thoughts, emotions, and behavior work together (GROUP 1), or ways to improve their use of healthy behavior like seatbelts and nutrition (GROUP 2). For both groups, we will also go over the text messaging system. During the session with your child, we will ask you to step out of the room and you will be given some handouts to read. If your child is discharged from the emergency department before finishing the in-person session, we will move to a private treatment room to finish it. It should not take more than 20-30 minutes to finish. The session will be digitally recorded for quality purposes. Recordings of the session will be kept confidential and will be stored in a locked file in a locked research office. All identifying information will be destroyed after the study is complete. The audio recordings will be destroyed 5 years after the close of the study. The purpose is to evaluate the performance of the study staff, not you. GROUP 1 participants will receive daily text messages that will provide skills on managing stressful situations. Each day, GROUP 1 participants will be automatically sent one text-message question about their day, followed by a text message just for your child. The text messages will provide skills on managing stressful situations. Although no one will be monitoring the text messages, our program can send extra messages on certain topics (“MOOD” and “FIGHT”) if your child needs them. GROUP 2 participants will receive regular text messages on topics related to diet and nutrition. Messages will be sent to your child’s cell phone using an automated computerized system developed by an outside company, Reify Health. Only members of this research team will see your child’s text messages and responses. For both groups, we will contact your child to complete a follow-up survey and brief interview (over the phone, in person, or over the internet) at 8 weeks and again at 16 weeks (since the start of the stu...
Explanation of Procedures. If authorized by the Sheriff’s Office, Contractor shall explain autopsy procedures and respond to questions during the autopsy.
Explanation of Procedures. If you take part in this study, you will be randomized to either a 12- week exercise program or a delayed exercise condition, meaning that you cannot choose which group you are placed in (see below for additional details explaining both conditions). You will also be asked to complete assessment visits before the start of the study, half way through the study, and at the end of the study and you will be compensated for the 6-week and 12-week assessments. The following outlines all study procedures.
