INFORMED CONSENT DOCUMENT—ON-SITE PROGRAM LEADER Title of Study: Promoting Older Adult Wellness through an Intergenerational Physical

Activity Program

Investigators:

Dr. Sarah L. Francis, Dept. of Food Science & Human Nutrition Dr. Warren Franke, Dept. of Kinesiology

Dr. Jennifer Margrett, Dept of Human Development and Family Studies Mr. Marc Petersen, ISU Extension—4H Youth Development

Ms. Kara Strand, Graduate Student

This is a research study. Please take your time in deciding if you would like to participate. Please feel free to ask questions at any time.

INTRODUCTION

The purpose of this study is to pilot test a community-based, intergenerational exergaming program for older and young adults (Living well through Intergenerational Fitness and Exercise [LIFE] Program). The study takes place in congregate mealsites and uses Wii Active to promote physical activity.

LIFE Program Description:

This study has two main parts: on-site physical activity (6 weeks) and follow-up

newsletters (16 weeks). The on-site component will be held twice weekly for six weeks for a total of 90 minutes of activity (Day 1: 30 minutes Wii®, Day 2: 30 minutes Wii® and 30 minutes interactive group games) led by a young adult trainer. Wii® is the primary means for physical activity promotion during the LIFE Program; however, once weekly 30-minute group activity will be included to promote dialogue between participants and young adult trainers. The selected Wii® exercises will focus on endurance, strength, flexibility and

balance. The newsletter intervention uses eight bi-monthly wellness newsletters. During the newsletter intervention, the young adult trainer-led program will not be conducted but the Wii® will remain on-site. On-site leaders will be encouraged to continue the program during the newsletter intervention (16 weeks).

To help us assess what was liked and disliked about the LIFE Program, you will be asked to participate in a focus group discussion. We will conduct four separate focus groups with: 1) trainers 2) participants 3) on-site leaders and 4) trainers and participants together. Focus groups will be asked to provide feedback regarding the program. The focus group discussions will be recorded; however names will not be used. The recordings will be transcribed by an independent party who will not know who attended the focus group session.

You are being invited to participate in this study because you meet the following qualifications to enroll as an on-site leader: 1) are enrolled in the LIFE Program as a participant, 2) willing to attend a two-hour on-site leader training workshop offered at the congregate mealsite [senior center] you attend, 3) willing to co-lead the on-site LIFE

program Week 6 with the Young Adult Trainer, 4) willing to lead the on-site LIFE Program after the young adult trainer has left (Weeks 7-25).

DESCRIPTION OF PROCEDURES

In addition to completing the tasks asked of you as a LIFE Program participant, you will also be asked to participate in a series of weekly trainings (starting Week 4) before or after the on- site program. The total training time will be about 4.5 hours. During these 15-20 minute twice weekly sessions you will work with the Trainer to learn how to set up the Wii

equipment, operate the Wii, and lead the interactive games. On-site leaders will co-lead the on-site program Week 6 with the young adult trainer and will lead it Week 7 (the young adult trainer will be there if assistance is needed) prior to the newsletter intervention. You will be expected to continue the on-site program during the newsletter intervention (16 weeks). You will also be asked to participate in a focus group to discuss your experience as an on-site leader. Finally, at the conclusion of the study you will complete an on-site leader program evaluation (about 10 minutes to complete). The program evaluation asks about what you liked and did not like about serving as a LIFE Program on-site leader.

RISKS

While participating in this study the risk to you is minimal. In addition to the potential risks as a participant, you may be uncomfortable being trained by a young adult and instructing your peers. You may also find completing the follow-up evaluation inconvenient. If you choose to participate in a focus group discussion, you may feel uncomfortable with discussing your opinions in front of a group and being recorded.

BENEFITS

If you decide to participate in this study there may be direct benefit to you including

increased fitness, subjective well-being and physical activity readiness to change. It is hoped that the information gained in this study will benefit society in that we will have created a physical activity program that improves health and encourages meaningful interaction between generations.

COSTS AND COMPENSATION

You will need to pay for travel from your house to the on-site program and back home. You will not receive financial compensation for serving as an on-site leader. As an on-site leader you will receive a t-shirt to wear when leading the on-site program so that participants can easily recognize you. This will be distributed at the training workshop.

If you choose to participate in a focus group, you will receive a small token of appreciation. You will need to complete a form stating you received this item. Thisinformation allows the University to fulfill government reporting requirements. Confidentiality measures are in place to keep this information secure. You may forego receipt of the item and continue in the

focus group discussion if you do not wish to complete this form. Information regarding documentation required for participant compensation may be obtained from the Controller’s Department; 294-2555 or http://www.controller.iastate.edu.

PARTICIPANT RIGHTS

Your participation in this study is completely voluntary and you may refuse to participate or leave the study at any time. If you decide to not participate in the study or leave the study early, it will not result in any penalty or loss of benefits to which you are otherwise entitled. When completing the research assessment tools (questionnaires and/or focus group

questions) you can skip any questions that you do not wish to answer. CONFIDENTIALITY

Records identifying all LIFE program members will be kept confidential to the extent permitted by applicable laws and regulations and will not be made publicly available. However, federal government regulatory agencies including the National Institute of Food and Agriculture (the funding agency), auditing departments of Iowa State University, and the Institutional Review Board (a committee that reviews and approves human subject research studies) may inspect and/or copy your records for quality assurance and data analysis. These records may contain private information.

To ensure confidentiality to the extent permitted by law, the following measures will be taken: each participant and trainer will be identified with a code number to which only the research team members have access. On-site leaders will be identified by the code assigned to them as a participant. Focus group participants will not be identified in any way.

Identifying documents (e.g. registration forms, permission forms, and emergency contact forms) will be kept in a locked cabinet separate from the coded documents in the PI’s office. The collected data will be kept for five years following the close of the study or until the results are published, whichever occurs first. If the results are published, your identity will remain confidential.

QUESTIONS OR PROBLEMS

You are encouraged to ask questions at any time during this study. For further information about the study contact Dr. Sarah L. Francis, 515-294-1456. If you have any questions about the rights of research subjects or research-related injury, please contact the IRB

Administrator, (515) 294-4566, [email protected], or Director, (515) 294-3115, Office for Responsible Research, Iowa State University, Ames, Iowa 50011.