More Information

The BRIDGE & Friends research study wants to understand how people share health and weight loss information and if sharing information about diet and exercise with friends and family can improve weight loss and healthy lifestyle change.

Friends and family who know and discuss health information with someone who is a participant in the BRIDGE & Friends research study.

About 536 people will be enrolled in this research study.

If you are eligible and agree to be a part of this study We will ask you questions about health information you may have heard about from a person you know that is in this study.

Data Collection

To participate in the research, you will need to answer some questionnaires about your height and weight, how you eat and your lifestyle, and eating and lifestyle information you may have from a person you know that is in this study.

If you are eligible and interested, we will immediately begin the data collection process. Data collection will take about 15 minutes to complete and can be done in person or over the phone.

We will ask you to repeat this data collection 2 more times over the next 6 months. We will conduct data collection now when you are joining the study, in 3 months and then again in 6 months.

Each of the 3 data collection periods will take place in person and will take 15 minutes.

Altogether, the data collection visits will take about 45 minutes to an hour complete.

You may or you may not directly benefit from participation in this study, but your participation may help researchers learn new things that will help others.

There are some potential risks associated with participating in this research:

1. You may feel some stomach discomfort if you change your diet as part of the study.
2. You may feel temporary soreness and fatigue or injuries like muscle strains as you increase your physical activity. There also a risk of more serious injury like cardiovascular event from increasing your physical activity.

This is not a treatment study. Your alternative is not to participate in this study. Additionally, exercise and nutritional guidance are commercially available outside of participation in this study.

For questions, concerns, or complaints about the study, please contact Dr. Marian Fitzgibbon at 312-636-4665 or email at mlf@uic.edu.

If you have a research related injury, you should immediately contact Research Manager Lara Blumstein at 312-996-9028.

If you have questions about your rights as a study subject; including questions, concerns, complaints, or if you feel you have not been treated according to the description in the consent form; or to offer input you may call the UIC Office for the Protection of Research Subjects (OPRS) at 312-996-1711 or e-mail OPRS at uicirb@uic.edu.

At the end of the study, we can share with you a summary about your eating and exercise changes over the time of the study.

Side effects, risks, and/or discomforts from participation in this study include:

1. You may feel some stomach discomfort as you change your diet as part of the study.
2. You may feel temporary soreness and fatigue or injuries like muscle strains as you increase your physical activity. There may be risks from the study that are not known at this time.

A risk of this research is a loss of privacy (revealing to others that you are taking part in this study) or confidentiality (revealing information about you to others to whom you have not given permission to see this information).

We will try to keep your information confidential by not sharing your information with others outside this research team. There can never be a guarantee of complete confidentiality.

Your data and information will be given a code, so that most people will not know that it is yours. The code will be stored in a safe place. When data from this research is shared, no one outside this research team will know it was you.

There will be times your information with your name has to be shared because of laws or other rules. For example, your information and the consent form signed by you may be looked at by these groups:

• People from a university committee and office that reviews and approves research studies, the Institutional Review Board (IRB) and Office for the Protection of Research Subjects.
• People representing the State and University responsible for ethical, regulatory, or financial oversight of research.
• Government Regulatory Agencies, such as the Office for Human Research Protections (OHRP).
• The National Institutes of Health
• The National Cancer Institute

A description of this study will be available on http://www.ClinicalTrials.gov, as required by U.S. law. This web site will not include information that can identify you. At most, the web site will include a summary of the results. You can search this web site at any time.

If you get ill or injured from being in the study, UIC will help you get medical treatment. You should let the study doctor know right away that you are ill or injured. If you believe you have become ill or injured from this study, you should contact Study Manager Lara Blumstein at (312) 996-9028.

You should let any health care provider who treats you know that you are in a research study. If you do seek medical treatment, please take a copy of the consent document with you because it may help the doctors where you seek treatment to treat you. It will also provide the doctors where you seek treatment with information they may need if they want to contact the research doctors.

You or your health insurance plan will be billed. No money has been set aside to pay the costs of this treatment. Health insurance plans may or may not cover costs of research-related injury or illness. You should check with your insurance company before deciding to participate in this research study. Costs not covered by insurance could be substantial.

UIC has not set aside any money to pay you or to pay for your treatment if you get ill or injured from being in the study. There are no plans for the University to provide other forms of compensation (such as lost wages or pain and suffering) to you for research related illnesses or injuries. The only exception to this policy is if it is proven that your injury or illness is directly caused by the negligence of UIC.

By signing the consent form, you are not giving up any legal rights to seek compensation of injury.

There are no costs to you for participating in this research.

If you complete the interview and data collection, you will be reimbursed $30 for your full participation in the first data collection period, $30 for your participation in the second data collection period and $30 for your participation in the third data collection period. Therefore, you may be reimbursed a total of $90 over the course of 6 months if you complete all phases of the research. If you do not finish the study, you will be compensated for the visits you have completed. You will be paid in cash at the end of each visit.

During the course of the study, you will be informed of any significant new research findings (either good or bad), such as changes in the risks or benefits resulting from participation in the research or new alternatives to participation, that might cause you to change your mind about continuing in the study.  If new information is provided to you, your consent to continue participating in this study may be re-obtained.

If you choose to be in the study, you have the right to withdraw your consent and leave the study at any time without penalty.

The researchers may stop your participation in this study without your consent.

If you choose to no longer be in the study, you must inform the researchers. The researchers may use your information that was collected before you left the study.

We often have research studies looking for participants meeting your eligibility criteria.

In the consent form, we will ask you: Following your participation with this research study, do you wish to be contacted about future research? As always, your future participation in any research study would be completely voluntary and would not affect your medical care.

Your participation in this research study is voluntary. Your choice whether or not to participate will not affect your ability to receive care or services from the University.  If you choose to participate, you are free to stop and withdraw at any time.

The consent document provides more information about this research study.

This document is for review purposes only. If friends and family are eligible to participate, they will be provided a consent form to sign.