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. 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:
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. (1) Police Officers maintain authority and responsibility for a potential crime scene at all time.
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 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 agree to take part in this study, you will first sign this consent form. The study staff will then verify you are eligible to take part in the study. You will not be able to take part in this study if you use a BAN as an outpatient at home. Once your eligibility is confirmed you will be randomly assigned “randomized” to receive nebulizer treatments with either SN or BAN. Randomization means you are put into a group by chance. It is like flipping a coin. You have an equal chance (50/50) of being placed in either group. Neither you, the study staff nor your doctor can pick which group you will be assigned. Once you are randomized you will begin to receive your nebulizer treatments only using the device you were assigned to. If you are assigned to SN you will continue to use the SN device (handheld or mask) as you were before enrolling in the study. If you are randomized to BAN, a nurse or respiratory therapist will show you how to use the BAN device. After signing the consent form patients in both groups willbe asked to complete the St. George’s Respiratory Questionnaire for COPD patients. This is a 14-question survey that should take 5-10 minutes to complete. You will also be asked to complete a daily, one question survey rating how you feel about your shortness of breath while you are on nebulizer treatments for up to 7 days. If you are in the BAN group at some point during your hospital stay (likely within 3-4 days) a member of the study staff will ask you to complete a short (less than 5 minutes) survey about how easy or difficult you feel the BAN was to use. Study staff will collect information from your medical record (for up to 6 months after you are discharged from the hospital) like the number of nebulizer treatments you receive, oxygen use, the need for breathing support, how long you stay in the hospital, pulmonary function test results performed after discharge and readmissions to the hospital. A member of the study team may call you after discharge during that 6 months to see how you are doing. They may also contact your primary care doctor or lung doctor. Your care will not be changed or influenced in any way by being in this study. You will receive nebulizer treatments as per your doctor’s orders as frequently and for as long as your doctor feels you need them. There is nothing else you need to do as part of your participation in the study. Costs for participating in this study Some of the services you will receive are being performed o...
Explanation of Procedures. If you decide that you are interested in taking part in this study, the next step is that you will complete a baseline assessment. As part of this assessment, we will measure your height and weight and you will be asked to complete a series of questionnaires, have a brief interview with study staff, wear an armband for 10 days, and answer surveys on your smartphone for 10 days. After completing each of these steps and if it is determined that you are eligible for the study, you will be asked to complete a 12-week weight loss program in which you will attend weekly, group-based meetings. Following this, you will receive one of two interventions aimed at improving long-term weight loss outcomes: cooking/dietary instruction classes or yoga (described in further detail below). Following the 12-week weight loss program, you will be randomly assigned “randomized into one of these study groups. Randomization means that you are put into a group by chance. It is like flipping a coin. Which group you are put in is done by a computer. Neither you nor the researcher will choose what group you will be in. You will have an equal chance of being in either of the two groups. Further, you will be asked to complete assessments at baseline, 12 weeks, 24 weeks, and 1 year which will be used to evaluate these programs. The assessment visits and weight loss programs are described in detail below. Assessment visits: Assessment visits will take approximately 1 hour to complete and will be completed at baseline, 12 weeks, 24 weeks, and 1 year. At each visit, you will be asked to complete multiple questionnaires and your height and weight will be measured. In addition, at the baseline, 12-week and 24-week assessments, you will be equipped with a physical activity monitor to wear, and you will be provided with instructions for the 10-day monitoring period. 10-day monitoring period: At baseline, 12, and 24 weeks you will be asked to wear a physical activity monitor (armband, which is worn on your upper arm) for 10 days. In addition, during this same 10-day period, you will also receive 5 text messages per day, delivered randomly to your smartphone between the hours of 8:00am and 10:00pm. When you receive these text messages, you will be asked to respond to a 3-5 minute survey. These surveys ask you about your mood, daily events, eating, and exercise behaviors. If you respond to less than 80% of these text messages at baseline or do not wear the armband as specified, you will not be e...
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...
