INTRODUCTION AND PURPOSE OF THE STUDY
You are being asked to take part in an online research study. The purpose of this study is to gain understanding of the psychological and physical conditions of weight loss participants who complete a 6-week online program. The study will involve about 100 participants. It will take place over the course of 1 to 2 years. If accepted into the study, you will receive a workbook, and email instructions at the start of each week. You will also participate in an online discussion group in which you share your experiences weekly. If you agree to take part in this study, you will first sign this Consent Form and fill in a short questionnaires that has been used in other studies. These forms can be completed in about ten minutes. After completing these forms, you will be notified if you are eligible for the study. If eligible, you will complete the forms again at the end of the online program, and after six months and 1 year after completing the program. All information you provide is confidential, and will not be seen by anyone other than the researchers conducting the study. After completing the forms the first time, you will be randomly assigned (by chance, like the flip of a coin) to one of two groups. Both groups will receive treatments that have been successfully used by weight loss participants in prior research. Once you have completed the six-month study period, you will be given the opportunity to experience the other group’s program if you choose.
Several other studies have found that there are no known risks to the treatments offered, or side effects, other than the possibility of uncomfortable body or emotional sensations as you discuss your thoughts and memories. There is no guarantee that any of your current psychological states will be improved by participation in this study. The investigators will tell you if any new findings arise that might cause you to change your mind about taking part in this study.
You are required to continue with your current medical care or medications while participating in this study. You do not have to take part in this study to receive treatment for psychological distress. If you decide not to take part in this study, there are other treatments for psychological distress. These are available from your doctor or psychologist in your primary care facility.
VOLUNTARY CONSENT AND SUBJECT WITHDRAWAL
Your decision to take part in this research study is completely voluntary. You have been told what your participation will involve, including the possible risks and benefits. There will not be any penalty or loss of benefits to you if you decide not to take part. You may withdraw from the study at any time. There will be no penalty if you decide to withdraw. Before withdrawing, please notify the investigator. You are encouraged to notify your primary care provider, such as your doctor or psychologist, that you have enrolled in this study, and to discuss potential risks and benefits with that person. The online programs used in this study are designed to supplement and support your regular medical and psychological care, and are not a substitute for regular professional care. The investigators, Soul Medicine Institute, or the FDA all have the right to stop your participation in the study at any time, with or without your consent, for any of the following reasons: if you have an adverse event, if you need a treatment not provided by this study, if you are not benefiting from participation, if you do not participate in the discussion groups, or if the study is canceled.
COMPENSATION IN CASE OF INJURY
If you are injured during the course of this research study you should seek medical attention from your primary care medical provider. The study does not have a program in place to provide compensation in the event of an injury.
POSSIBLE BENEFITS TO SUBJECTS
The possible benefits of participating in this study are an improvement in your psychological and physical condition. Your participation in the study will contribute to information about weight loss and may benefit other people in the future.
You will not receive payment for your participation in this study. You do not have to pay for the program you will receive during the course of the study.
CONSENT STATEMENT AND CONFIDENTIALITY
The investigators and practitioners will protect information about you and your taking part in this research study to the best of their ability. If information about this study is published, your identity will remain confidential. However, the U.S. Food and Drug Administration (FDA), and the AAABEM IRB, have the right to inspect the forms you fill out during the course of this study. By signing this consent form, you are authorizing such access. This consent is based on the verbal and written information provided to you and the understanding that you are medically qualified to participate in this study. You may ask questions at any time. In case of an adverse reaction, call the investigators or coordinators listed above. If you cannot reach any of them then call Dr. Duarte, Chairperson for AAABEM, IRB also listed on the first page. If you have a medical emergency call 911. You will receive a copy of this form to keep for your records. You do not waive any legal rights by signing this Consent Form, or restrict your right to seek legal assistance.
Since the ability to read is a requirement of this study, illiterate subjects cannot participate. I have read this form and I understand it. I have had all my questions answered to my satisfaction. I understand the risks and benefits of participation in this study. I am over 18 years old. I am not on a mission of entrapment or investigation. I make these statements on my own behalf and not as an agent for federal, state or local agencies.