Screening Consent |
RESEARCH PARTICIPANT CONSENT INFORMATION
FOR SCREENING SURVEY
STUDY TITLE: Piloting a novel intuitive eating intervention for college women with disordered eating
VCU INVESTIGATOR: Suzanne Mazzeo, PhD
ABOUT THIS CONSENT FORM
You are being invited to participate in a research study. It is important that you carefully think about whether being in this study is right for you and your situation.
This consent form is meant to assist you in thinking about whether or not you want to be in this study. Please ask the investigator or the study staff to explain any information in this consent document that is not clear to you. You may print a copy of this consent information to think about or discuss with family or friends before making your decision.
Your participation is voluntary. You may choose to not take this screening survey, stop the survey at any time, or skip any questions with no penalty or loss of benefits to which you are otherwise entitled.
WHAT AM I BEING ASKED TO DO?
The purpose of this 10-minute screening survey is to see if you meet the criteria to be in a research study. If you agree to take the survey, you will be asked questions about your demographics, mental health, eating habits and body image.
You will not receive instant feedback on your screening questionnaire. However, we intend to provide notice of eligibility within 5 business days. If your answers to the screener indicate that you are ineligible for the study, we will provide resources that can address any eating-related concerns you might have.
If you are eligible, you will be invited to participate in a program where you learn: about the negative effects of dieting and restrictive behaviors, to increase food flexibility and awareness of your hunger and fullness cues, to rely on these cues to guide eating rather than dietary rules, to identify emotional eating triggers, to engage in mindful movement, to accept your body’s unique genetic blueprint, and to choose foods that are satisfying and nourishing.
You will be randomized to either a group version of the program or to guided self-help. You will not be able to choose what version you participate in, but you have the option to decline or stop participating at any time
Participants in the group condition will meet for 1.5 hours weekly (over an 8-week period) at the Wellness Resource Center. Groups will include about 6 – 10 young adult women. If you are in the guided self-help condition, you will have weekly individual phone sessions with a study interventionist. These phone calls will last approximately 20 minutes and will occur at the same day/time each week (chosen by you and the interventionist).
Additionally, you will fill out a set of online questionnaires at three different time points: before the group or phone sessions (i.e., today), at the end of the group/phone sessions, and two months after the group/phone sessions. These surveys will take you approximately 30 minutes to complete. Questions will ask about your eating and exercise behaviors and attitudes, level of body appreciation, body awareness, feelings of weight stigma, family history, and satisfaction with life.
WHAT ARE THE RISKS AND BENEFITS OF TAKING THIS SURVEY?
Possible risks of this screening survey include feelings of discomfort or distress elicited by the topics discussed. On this screener, you can choose not to answer any questions. However, if you do skip screening items, you cannot be considered for enrollment into the study. There is also a small risk that someone outside the study could see and misuse information about you. You will not benefit from taking this survey.
HOW WILL INFORMATION ABOUT ME BE PROTECTED?
Information that you give me will be kept as confidential as possible by storing it in secure databases accessible only to the following people: study personnel, authorized people at VCU or VCUHS who oversee research, and authorized officials of the Department of Health and Human Services.
In the future, identifiers might be removed from the information you provide in this survey, and after that removal, the information could be used for other research studies by this study team or another researcher without asking you for additional consent.
WILL I BE PAID TO PARTICIPATE?
There is no compensation for completing this screener.
WHO SHOULD I CONTACT IF I HAVE QUESTIONS?
If you have any questions, complaints, or concerns about your participation in this research, contact:
Suzanne Mazzeo, PhD, Professor of Psychology (semazzeo@vcu.edu), 804-827- 9211
or
Blair Burnette, MS, Graduate Student (burnettecb@vcu.edu), 615-308-4769
The researcher/study staff named above is the best person(s) to call for questions about your participation in this study. If you have general questions about your rights as a participant in this or any other research, you may contact:
Virginia Commonwealth University Office of Research
800 East Leigh Street, Suite 3000
Box 980568
Richmond, VA 23298
Telephone: (804) 827-2157
Contact this number to ask general questions, to obtain information or offer input, and to express concerns or complaints about research. You may also call this number if you cannot reach the research team or if you wish to talk to someone else. General information about participation in research studies can also be found at http://www.research.vcu.edu/irb/volunteers.htm.
If you experience any distress from completing these surveys, you may contact University Counseling Services (UCS) at 804-828-6200 or walk-in during business hours (8-4:30 M-F) to speak with a counselor.
If you have any questions, please contact the study team before taking the survey.