Consent

must be completed by a parent or guardian
if the participant is a minor

Invitation to take part in a research study

Dr. Sarah E. Messiah is inviting you to take part in a research study. You need to know about the study so you can decide if you would like to join the study or not. If you enter the study, you will be asked to sign this form. You may take this paper home to talk with your family and friends before making your decision.

Your parent(s) or legal guardian will also be asked to give their permission for you to take part in this study. Please talk this over with your parent(s) or legal guardian before you decide whether or not to be in the study.

Who is eligible for this study?

To be eligible, you must:

• Be between 12-18 years of age.
• Have parent/guardian permission to participate if you are a minor.
• Be a patient referred for bariatric surgery at Children's Health.
• Not have diabetes that requires taking mealtime insulin.
• Have a Facebook account to access the healthy lifestyle intervention.

Why is this study being done?

We are inviting you to take part in a research study because we are trying to learn more about your decision to have weight loss surgery, and what online tools such as social media, blogs, online chatrooms and apps, etc. that you would be interested in using to help with your weight loss journey before and after surgery.

Why am I being asked to take part in this research study?

We are inviting you to take part in this research study because you have decided to have bariatric surgery.

How many people will take part in this study?

About 20 adolescents ages 12-18 will be in this study. This study will be done at about four Children's Health sites in the Dallas-Fort Worth area.

What is involved in the study?

If you agree to be in this study, the following things will happen:

• You must consent to participate in the study.
• You will be in the study for 18 months.
• You will have up to four follow-ups in total. One before surgery, and the remaining follow-ups after the surgery.
  
• You will be asked to spend a total of up to 26 hours in the study. Before surgery, you will be asked to participate in online educational sessions to learn more about weight loss surgery. After you have your surgery, we will ask you to participate in online educational sessions where you will be provided with information and tools to help you on your weight loss journey.
  

How long will this take?

You will be in the study for 18 months. During this time you will be asked to participate in follow-up surveys and take part in educational content that will support your weight loss journey. The total amount of time you will spend in the study is 26 hours.

What are the benefits of taking part in this study?

Taking part in this study may or may not provide you with support for weight loss. Information from this study might help researchers to come up with programs that can provide support before and after weight loss surgery.

What are some of the risks and discomforts?

• Psychological Stress: The risk of taking part in this study are minimal. At times you may feel awkward or embarrassed while answering the questions. However, you do not have to answer questions that you are not comfortable answering.
• Loss of Confidentiality: Any time information is collected; there is a potential risk of loss of confidentiality. Every effort will be made to keep your information confidential; however, this cannot be guaranteed.
• Other Risks: If you suffer an injury as a result of taking part in this research study, please understand that nothing has been arranged to provide free treatment of the injury or any other type of payment. However, necessary facilities, emergency treatment, and professional services will be available to you, just as they are to the general community. You should report any such injury to the Principal Investigator Dr. Sarah E. Barlow at 214-456-5466. You will not give up any of your legal rights by signing this consent form.
  

What options are available if I decide not to take part in this research study?

You will continue in the bariatric surgery program without study participation.

Can I stop taking part in this study?

You may decide to stop taking part in the study at any time. To withdraw from the study, please contact the Principal Investigator Dr. Sarah E. Barlow at 214-456-5466.

Your doctor or the sponsor can stop the study at any time. Your doctor or the sponsor may stop your participation in the study if you do not meet all the requirements of the study, or if the study is not in your best interest.

If you stop participating in this study, the information already collected will still be used in the data analysis. However, no further information will be collected without your permission.

While taking part in this study, the study team will notify you of new information that may become available and could affect your willingness to stay in the study.

Is there a cost to be in the study?

There is no cost to take part in the study.

Will I be paid if I take part in this research study?

You may receive a total of 3 gift cards over the 18-month period that you are enrolled in the study. The gift cards may be provided at 3 specific clinical visits. The first gift card of $20 may be provided to you at your 6-week post-operative clinical visit, the second gift card of $25 at the 3-month post-operative clinical visit, and lastly, the third gift card of $30 at the 6-month post-operative clinical visit.

You may also receive a Fitbit fitness tracker, a smart scale, resistance bands, dumbbell set, and a water bottle. You may be provided a water bottle at your first visit. Upon completion of your surgery you may recieve the fitness tracker, the smart scale, resistance bands, and dumbbells to aid in your weight loss journey while in the study. Please note that the technology provided to you are not medical devices.

Will my information be kept confidential?

Your privacy is important and your participation in this study will be kept confidential. However, absolute confidentiality cannot be guaranteed.

If you sign this document, you give permission to UTHealth Houston, UT Southwestern, and Children's Health to use and disclose (release) your health information. The health information that we may use or disclose for this research includes medical records, medical history, nutrition, exercise behavior, lab tests pertaining to bariatric surgery, and obesity-related comorbidities. Please understand that health information used and disclosed may include information relating to behavioral health, and psychiatric care.

Personal identifiers such as your name and medical record number will be removed from the information and samples collected in this study. After we remove all identifiers, the information or samples may be used for future research or shared with other researchers without your additional permission.

Representatives of the organizations listed below will see your and other personal identifiers when they review your research records and medical records for the purposes of verifying study data:

• Representatives of UTHealth Houston
• Representatives of UT Southwestern
• Representatives of Children's Health

What if you have any questions?

You can ask questions at any time. You can ask now, or you can ask later. You can talk to the study doctor or you can talk to the study coordinator Rashon King. If you would like to talk to the study coordinator, she can be contacted at 972-546-2958.

The Committee for Protection of Human Subjects at the University of Texas Health Science Center has reviewed this research study. You may contact them for any questions about your rights as a research subject, and to discuss any concerns, comments, or complaints about taking part in a research study at 713-500-7943.

Authorization for Use and Disclosure of
Health Information for Research Purposes

Research policies require that private information about you be protected and this is especially true for your health information. However, the law sometimes allows or requires others to see your information. The information given below describes how your privacy and the confidentiality of your research records will be protected in this study. Medical information collected during this study and the results of any test or procedure that may affect your medical care may be included in your medical record. The information included in your medical record will be available to healthcare providers and authorized persons including your insurance company.

What is Protected Health Information (PHI)?

Protected Health Information is information about a person's health that includes information that would make it
possible to figure out whose it is. According to the law, you have the right to decide who can see your protected health information. If you choose to take part in this study, you will be giving your permission to the investigators and the research study staff (individuals carrying out the study) to see and use your health information for this research study. In carrying out this research, the health information we will see and use about you will include information on your medical history, physical examination, body composition measures, and lab tests pertaining to bariatric surgery and obesity-related co-morbidities. Please understand that health information used and disclosed may include information relating to behavioral health, and psychiatric care.

We will get this information by accessing your medical records and asking you specific questions through questionnaires, group discussions, phone discussions, or an online video conversation.

How will your PHI be shared?

Because this is a research study, we will be unable to keep your PHI completely confidential. We may share your health information with people and groups involved in overseeing this research study including:

• The Sponsor, NIH-National Institute of Child Health and Human Development, funding the study. The sponsor includes any people, entities, groups, or companies working for or with the sponsor or owned by the sponsor. The sponsor will receive written reports about your participation in the research. The sponsor may look at your health information to assure the quality of the information used in the research. The data that will be sent to the sponsor will not include your name but may include your initials, date of birth, date of study visits, and date of study procedures.
• The following collaborators at other institutions that are involved with the study: Dr. Sarah E. Messiah (UTHealth Houston)
• The members of the local research team.
• The Human Research Protection Program Office and the Compliance Office of the University of Texas Southwestern Medical Center, and other groups that oversee how research studies are carried out.
• The Research offices at the University of Texas Southwestern Medical Center, Children's Medical Center of Dallas and any of its affiliated entities, and UTHealth Houston.
• Representatives of domestic and foreign governmental and regulatory agencies may be granted direct access to your health information for oversight, compliance activities, and determination of approval for new medicines, devices, or procedures.

If you decide to participate in this study, you will be giving your permission for the groups named above, to collect, use, and share your health information. If you choose not to let these groups collect, use, and share your health information as explained above, you will not be able to participate in the research study.

Parts of your PHI may be photocopied and sent to a central location or it may be transmitted electronically, such as by email or fax. The groups receiving your health information may not be obligated to keep it private. They may pass the information on to other groups or individuals not named here.

How will your PHI be protected?

In an effort to protect your privacy, the study staff will use code numbers instead of your name, to identify your health information. Initials and numbers will be used on any photocopies of your study records, and other study materials containing health information that are sent outside of UTHealth Houston OR Children's Health for review or testing. If the results of this study are reported in medical journals or at meetings, you will not be identified.

Do you have to allow the use of your health information?

You do not have to allow (authorize) the researchers and other groups to see and share your health information. If you choose not to let the researchers and other groups use your health information, there will be no penalties but you will not be allowed to participate in the study.

After you enroll in this study, you may ask the researchers to stop using your health information at any time. However, you need to say this in writing and send your letter to Sarah E. Barlow at 1935 Medical District Mailstop F4123, Dallas, TX 75235. If you tell the researchers to stop using your health information, your participation in the study will end and the study staff will stop collecting new health information from you and about you for this study. However, the study staff will continue to use the health information collected up to the time they receive your letter asking them to stop.

Can you ask to see the PHI that is collected about you for this study?

The federal rules say that you can see the health information that we collect about you and use in this study. Contact the study staff if you have a need to review your PHI collected for this study.

Because of the type of research, you can only access your PHI when the study is done. At that time, you have the right to see and copy the medical information we collect about you during the study, for as long as that information is kept by the study staff and other groups involved.

How long will your PHI be used?

By signing this form, you agree to let us use and disclose your health information for purposes of the study until 15 years after the end of the study. This permission to use your personal health information expires when 15 years have concluded after the research ends and all required study monitoring is over.

Additional questions about your rights

The University of Texas Southwestern Medical Center Participant Advocate will answer any questions about your rights as a research subject and take any concerns, comments, or complaints you may wish to offer. You can contact the Participant Advocate by calling the office at 214-648-3060.

To access our private Facebook group, visit https://www.facebook.com/groups/teenlyft and click the 'Join group' button.

To access our private Facebook group, visit https://www.facebook.com/groups/teenlyft and click the 'Join group' button.