APPENDIX C: CONSENT FORM

A Brief Intervention for Eating and Weight Regulation among College Freshmen: A Randomized Clinical Trial

You are invited to be in a research study aimed at preventing unintended weight gain among college freshmen women. You were selected as a possible participant because you are a UMD freshman woman between the ages of 18-20, living in a dormitory on campus. We ask that you read this form and ask any questions you may have before agreeing to be in the study.

This study is being conducted by: Lara LaCaille, PhD, a faculty member in the Psychology Department at the University of Minnesota Duluth, and Claire Guidinger, a graduate psychology student at the University of Minnesota Duluth.

Background Information

The purpose of this study is to assess the effectiveness of two different interventions targeting healthy eating practices in order to prevent weight gain.

Procedures

If you agree to be in this study, we would ask you to consent to random assignment to one of three groups: an appetite awareness training intervention, a nutritional education intervention, or a no-treatment control group. Participants in the appetite awareness and nutritional education interventions will be asked to participate in 4 in-person group sessions lasting 1 hour each. These will take place during the first half of this Fall semester. Group sessions will consist of

approximately 10 female students and 2 research staff, and will take place on the university campus. You will be asked to attend all 4 sessions if possible, in which you will learn about various strategies to eat in a healthy manner that will help you manage your weight. If randomized to the control group, you will not receive any intervention during the assessment period, but will have the opportunity to participate in a seminar covering the intervention material after the completion of the study. Participants in all three groups will be asked to have their physical measurements taken including weight, height, and % body fat and complete online surveys assessing eating and health habits, dieting and physical activity history, and mood assessments at three different points in time. The surveys are estimated to take approximately 30 minutes each.

Risks and Benefits of being in the Study

There are minimal risks associated with your participation in this study. You may potentially be uncomfortable with some of the survey questions or with being weighed. You will be asked questions like, “During the past 30 days, how many days did you have at least one drink of any alcoholic beverage such as beer, wine, a malt beverage, or liquor?” and “Over the past four

weeks, how many times have you taken laxatives as a means of controlling your shape or weight?” You need not answer any questions that make you uncomfortable. When being weighed, all measurements will be taken in a private area and will be conducted by trained members of the research team. There is also the potential for breach of confidentiality as it is necessary to place your name on your completed surveys. Precautions will be taken to ensure your right to confidentiality and privacy is maintained. You may experience changes in your diet as a result from your participation; however, these are expected to be positive changes.

The benefits to participation include the potential to learn new healthy eating habits and prevent unintended weight gain.

Compensation

You will receive payment in the form of two Amazon gift cards for your participation in this study. You will receive one $50 gift card for completing the second assessment (at week 6), and one $25 gift card for completing the third assessment (during Spring semester). If you complete both the second and third assessment, you will receive a total of $75 between two gift cards.

Confidentiality

The records of this study will be kept private and the only people who will see your responses will be the research staff. In any sort of report we might publish, we will not include any information that will make it possible to identify a subject. Research records will be stored securely according to current University policy for protection of confidentiality, and only researchers will have access to the records.

Voluntary Nature of the Study

Participation in this study is voluntary. Your decision whether or not to participate will not affect your current or future relations with the University of Minnesota. If you decide to participate, you are free to not answer any question or withdraw at any time without affecting those relationships.

Contacts and Questions:

The researchers conducting this study are: Dr. Lara LaCaille and Claire Guidinger. You may ask any questions you have now. If you have questions later, you are encouraged to contact them at through the University of Minnesota Duluth Psychology office (320 Bohannon Hall), at (218) 726-7364, or by email [email protected].

If you have any questions or concerns regarding this study and would like to talk to someone other than the researcher(s), you are encouraged to contact the Research Subjects’ Advocate Line, D528 Mayo, 420 Delaware St. Southeast, Minneapolis, Minnesota 55455; (612) 625-1650.

You will be given a copy of this information to keep for your records.

Statement of Consent

I have read the above information. I have asked questions and have received answers. I consent to participate in the study.

Signature: ______________________________________________ Date: _________________

Signature of Investigator: _________________________________ Date: __________________

APPENDIX D: STUDY QUESTIONNAIRES