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 ▇▇▇▇▇▇ 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 specific school hours. On 3 randomly selected days, your child will also be asked to complete a dietary recall. For these recalls, a trained and registered dietician will call your child and ask about their eating. Two of these dietary recalls will occur during weekdays, and one will occur on the weekend. At the end of the 15-day assessment period, you will be asked to return to the Weight Control & Diabetes Research Center to have you and your child’s weight measured, receive cash compensation, return any study-loaned smartphone, and complete repeated assessments of eating behavior to assess potential changes. We think you will be in the study for about 4 weeks, starting from the time we spoke to you on the phone, until you finish the 15-day assessment period and in-person follow-up visit. Each of these in-person visits will take about 2 hours. We will try to schedule your visits close together so it’s easier for you. Eligible participants will receive up to $100 for completion of study procedures ($50 for the intake assessment, and $50 for completion of the 2-week protocol) plus additional incentives for timely responses to random signals and dietary recalls (e.g., $1 for each survey and dietary recall completed). Participants have the potential to earn a maximum of $153, assuming perfect compliance to all study visits, surveys, and dietary recalls. Any money your child earns for completing surveys and dietary recalls during the assessment period will be given to them at the follow-up visit. ▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇▇▇, Ph.D., (▇▇▇-▇▇▇-▇▇▇▇; ▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇., ▇▇▇▇▇▇▇▇▇▇, ▇▇, ▇▇▇▇▇) will be available to answer questions for research study volunteers about the study or any concerns about side effects/problems.
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Sources: Research Participation Agreement
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 and to allow your child to participate, you and your child will be asked to sign these documents indicating this consent document. You and your willingness child will also be asked to participate and complete an in-person interview and several questionnaires to further that will determine eligibilityif they are eligible for this study. If your child is eligible and you both have agreed to participate, you and your child will be asked to stay at the Weight Control and Diabetes Research Center for approximately 2 hourshours for an assessment visit. You will receive a detailed study explanationDuring this time, 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 you and your child will have their height and weight measured and complete assessments of eating behaviors, cognitive functioningmeasured, and psychiatric comorbiditiesyou and your child will complete several questionnaires, interviews, and tasks about his or her eating habits and psychological functioning. We will collect information about you for the purposes of this research. This includes your name, your address, phone number, e- mail address, gender, and your child’s age and date of birth. We would like to record the interview interviews 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 and/or your child will be asked to complete a questionnaire which addresses how physically developed your child has become, in terms of genital (penis, testicle, or labial) growth, the emergence and growth of hair around the genitalsgenitals and under the arms, as well as other parts of the body, and the appearance of breasts in girls. This is called ▇▇▇▇▇▇ 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 After the assessment visit, your child will then come back for a second 2-hour visit to participate in a MRI scan at Brown University while they are viewing different words and responding during a task designed to assess their memory. An MRI scanner uses a magnet and radio waves to take pictures of your child’s brain. Your child will need to lie still for the scanner for up to an hour. Being in the MRI scanner will not be painful for your child, but some children get antsy or nervous being in the scanner, and some children become anxious or claustrophobic from lying in an enclosed space. Someone will be in a room close by while they are in the scanner, and your child will be able to tell them if s/he wants to come out. Your child will have to remove any metal items they are wearing or have on, like jewelry, cell phones, or coins. They also need to make sure they don’t wear any clothes with metal zips, fasteners, buttons, belts or buckles. Make sure to tell someone if your child has an artificial limb or joint, a pacemaker, or screws or plates in their body from a previous surgery. This is because the magnet in the MRI scanner is very strong so if it comes in contact with any metal it could be dangerous for your child. You will be asked to complete questionnaires an additional consent form which describes the risks 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 specific school hours. On 3 randomly selected days, your child will also be asked to complete a dietary recall. For these recalls, a trained and registered dietician will call your child and ask about their eating. Two benefits of these dietary recalls will occur during weekdays, and one will occur on the weekend. At the end of the 15-day assessment period, you will be asked to return to the Weight Control & Diabetes Research Center to have you and your child’s weight measured, receive cash compensation, return any study-loaned smartphone, and complete repeated assessments of eating behavior to assess potential changesMRI procedures in greater detail. We think you will be in the study for about 4 2-3 weeks, starting from the time we spoke to you on the phone, until you finish the 15-day assessment period and two in-person follow-up visitstudy visits. Each of these in-person The two visits will take about 2 hourshours each. We will try to schedule your visits close together so it’s easier for you. Eligible participants Your child will receive up to $100 75 in cash at the end of each study visit for completion of participating in this study procedures ($50 for the intake assessment, and $50 for completion of the 2-week protocol) plus additional incentives for timely responses to random signals and dietary recalls (e.g., $1 for each survey and dietary recall completed150 total). Participants have the potential to earn a maximum of $153, assuming perfect compliance to all study visits, surveys, and dietary recalls. Any money your child earns for completing surveys and dietary recalls during the assessment period will be given to them at the follow-up visit. ▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇▇▇, Ph.D., PhD (▇▇▇-▇▇▇-▇▇▇▇; ▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇., ▇▇▇▇▇▇▇▇▇▇, ▇▇, ▇▇▇▇▇) will be available to answer questions for research study volunteers about the study or any concerns about side effects/problemseffects /problems.
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