Health Screener Consent | Shift Into Better Health

Shift into Better Health 2021 – Male Truck Driver Podcast Study

Thank you for your interest in the Shift into Better Health 2021 – Male Truck Driver Podcast Study. Every program requires some legal paperwork. It only takes 2 or 3 minutes to read over this material and complete the consent to get started on your journey to better health.

What should I know about this research?

On behalf of the Centers for Disease Control and Prevention’s Division of Diabetes Translation, ICF and its partners (the Association of Diabetes Care & Education Specialists (ADCES), and the Healthy Trucking Association of America (HTAA)) are conducting this study to see if audio podcasts consisting of key messages and tips to eat healthy, lose weight, become more physically active, and manage stress encourages male professional drivers to complete Omada’s online Diabetes Prevention Lifestyle Change Program.

Who is eligible to participate in this research?

We are looking for male professional drivers who are between the ages 35 – 65, drive more than 500 miles per day, and are at risk for type 2 diabetes.

What happens if I agree to participate in this research?

If you are eligible and agree to participate in the study, here are some points to know:

Rights Regarding Participation: Your participation is completely voluntary. You may choose to leave the study at any time for any reason. If you have any questions about the project, please contact the Research Director, Bhuvana Sukumar, PhD, at 404-592-2122.
Privacy: To conduct this study, the project staff must collect, use, and share personal information about you, including your health information and information that can identify you. Information will be collected during study enrollment and over the course of Omada’s lifestyle change program. We will take every precaution to protect your identity and ensure your privacy. ICF, ADCES, HTAA, and Omada will keep your name and contact information private. No personally identifiable information will be shared with CDC or your employer. See additional provisions about privacy below.
Benefits: Participation in this research may help you improve your health. Also, you will be able to participate in the Omada virtual lifestyle change program at no cost (a value of $650).
Risks: We do not anticipate any risks to you for participating in our study.

As part of the study you will enroll and participate in the Omada’s online Diabetes Prevention Lifestyle Change Program, receive podcasts linked to each session and receive support from HTAA and Omada coaches. There is no financial cost to you for your participation in the study.

What information will be collected and shared?

Full name/member ID, date of birth, email, phone number, dependent status, clinical condition, race/ethnicity, applied date, accepted date, rejection date, rejection reason, account set up date, enrolled date, account disabled date, baseline weight, number of weigh-ins, cumulative weigh-ins, weekly median weight loss %, reached Medium Weight for Calendar Month (MWCM) 5% weight loss date, reached MWCM 10% weight loss date, lessons completed, cumulative lessons completed, lesson 9 milestone completed date, lesson 16 milestone completed date, program week, program week start date, days of physical activity, cumulative days of physical activity.

With whom will your information be shared?

ICF, ADCES, and HTAA

For what purpose will your information be shared?

To see if tailoring audio podcast messages for professional drivers helps them to attend the online Omada virtual lifestyle change program and complete the program.
If the audio podcasts are found to benefit professional drivers, they can be shared with other drivers who have prediabetes or are at risk for type 2 diabetes.

Omada, who will collect health information from you as part of how it provides Diabetes Prevention Program services to you if you choose to participate in the study, is required by Federal privacy laws (such as HIPAA and the Privacy Rule) to protect it and must have your permission to collect and use or share health information that identifies you for this study. By clicking “NEXT” below, you are providing Omada with this permission.

You do not have to give this permission. If you decide not to give this permission, you will not be eligible to participate in this study, but you can still participate in Omada’s lifestyle change program. Here is the link to the OMADA program.

How long will I be in this research?

The Shift into Better Health 2021 – Male Truck Driver Podcast Study is a yearlong program, and your participation in this study will be one year from when you start the Omada program.

What happens if I agree to be in this research, but I change my mind later?

You may end your participation at any time by providing a written notice to Omada or the Shift into Better Health 2021 study staff.
You will no longer be able to participate in the Shift into Better Health 2021 study, and the study staff will provide you with a Withdrawal of Study Participation form to document your decision.
The study staff may still use or disclose the health information that they collected about you before you cancelled your permission. However, Omada and study staff will no longer collect your health information once you have withdrawn from the study. Please note that you will still be enrolled in the Omada program even if you withdraw from the study.

How will my information be used and kept confidential?

Your identifiable information can be accessed by Omada and study staff. To protect your identity, information that is collected for this study will be recorded by using a code instead of your name. However, access to your identifiable information may be necessary for our health coaches to stay in contact with you throughout the study. This section will explain how your coded and identifiable records will be used and shared for this research study.

Identifiable Records

Authorized representatives from the following organizations may be given access to your identifiable records, but only for the following reasons related to the research study:

ICF — Implementation of the Shift into Better Health 2021 – Male Truck Driver Podcast Study
OMADA —To make sure that you have given permission to share your health information before sharing it with ICF, ADCES, and HTAA
ADCES— Implementation of the Shift into Better Health 2021 – Male Truck Driver Podcast Study
HTAA—Health Coaches will contact you before and during the study

In addition, Omada will collect appropriate health information from you as it supplies the Omada program to you. Only a subset of that information that is described in the paragraph above labeled “What Information Will be Collected and Shared” will be shared with the Study Team. For example, in the Omada program, you will be paired with a professional coach assigned to you. Any messages between you and the coach, or any messages you post on Omada group boards, will NOT be shared with the Study team. Omada’s HIPAA Notice of Privacy Practices is found here.

Publication of Study Results

Results of this study may be published in a scientific journal or book or used in scientific discussions after all identifying data has been removed.

How will my information be used in the future?

Your personal information collected by the ICF Study team during the Shift into Better Health 2021 study will be securely destroyed at the end of the study. Your personal information will NOT be used for future research. The health information you supply to Omada Health as part of receiving the Omada program will be stored securely as is more fully described in Omada’s Terms of Use, Privacy Policy, and HIPAA Notice of Privacy Practices.

By clicking NEXT, you have agreed to the following:

You have read and understand the information in this document,
You are willing to share your contact information with Omada, ADCES, and HTAA,
You agree to be contacted by an HTAA Health Coach, and
If you are eligible and you enroll in the Omada virtual diabetes prevention program, you agree to allow Omada to share identifiable information (see What information will be collected and shared? section above) with ICF.