3 WINS Fitness Program
3 WINS Fitness will be following COVID related guidelines provided by Los Angeles County Department of Public Health and California State University Northridge. In an abundance of caution, our instructors may be wearing masks to cover their mouth and nose while instructing. Classes/sessions will be outdoor. In the event of poor weather, classes/sessions may be cancelled or moved to an indoor location. We will weigh participants and conduct questionnaire surveys/interviews periodically.. Masks may be required during indoor sessions/activities consistent with the policies and orders of Los Angeles County Department of Public Health and California State University Northridge. We will be encouraging participants to spread themselves by 6 feet. We will work with the parks to have hand sanitation supplies available and for the foreseeable future, we will be going equipment less though we will phase in equipment as feasible. We encourage you to also bring your own hand sanitizing supplies as we begin to introduce equipment. We encourage you to bring your own mats for ground exercises and bring your own water to prevent dehydration.
Your participation in face-to-face research/exercise may increase your risk of exposure to the virus that causes COVID-19 which can cause severe illness, hospitalization and death. Symptoms of COVID-19 include, but are not limited to, a new onset of a cough, sore throat, shortness of breath, respiratory distress, diarrhea, or an unusual rash. They may also include a fever that is at or over 100.4 degrees Fahrenheit. If you experience any of these symptoms, please seek medical advice. http://www.publichealth.lacounty.gov/chs/SPA2/ provides community health services information.
You are being asked to participate in a research study. Participation in this study is completely voluntary. Please read the information below and ask questions about anything that you do not understand before deciding if you want to participate. Steven Loy will be able to answer your questions.
Steven Loy, Ph. D.
Department of Kinesiology
California State University Northridge
18111 Nordhoff Street, Northridge, CA 91330-8287
Phone: (818) 677-3220
Email: steven.loy@csun.edu
Jimmy Xie, Ph. D.
College of Health and Human Development
California State University Northridge
18111 Nordhoff Street, Northridge, CA 91330-8269
Phone: (818) 677-5896
Email: jimmy.xie@csun.edu
The research team will include faculty from California State University, Northridge. They include Drs. Lisa Chaudhari and Suzanne Spear.
What is the purpose of this study?
The purpose of this study is to examine how 3WINS Fitness Program affects participants’ weight, fitness, and health behavior and outcomes.
Who may participate?
You are eligible to participate in this study if you are an adult aged 18 years of age and over and have completed the Health Screening form. ANSWERING YES TO ANY QUESTIONS IN THE PHYSICAL ACTIVITY READINESS QUESTIONNAIRE (2021 PAR-Q+) WILL DISQUALIFY YOU FROM CONTINUING. YOU WILL BE ASKED TO COMPLETE PAGES 2-4 AND BRING THE COPY TO YOUR MEDICAL DOCTOR ALONG WITH THE 3 WINS FITNESS CLEARANCE FORM. YOU WILL BE ALLOWED TO PARTICIPATE WHEN THE MEDICAL CLEARANCE FORM IS RETURNED WITH YOUR DOCTOR’S SIGNATURE.
Related: If you have experienced any adverse event such as broken bones, stroke, heart attack, (Questions 1 and 6 on Par-Q+) or an event that has resulted in hospitalization you will require a signed clearance form by your primary physician before engagement in the program is permitted.
How much of your time is expected?
This study will involve approximately 4 hours a week and it will be ongoing.
What does this study involve?
A screening session
- You will voluntarily sign the informed consent form and a Bill of Rights form.
- You will then be asked to complete the CDC Prediabetes screening test.
- You will complete a Health Screening form (2021 PAR-Q+). AN X THROUGH a YES BOX IN QUESTIONS 1-7 ON PAGE 1 WILL DISQUALIFY YOU FROM CONTINUING UNTIL THE MEDICAL CLEARANCE FORM IS RETURNED WITH YOUR DOCTOR’S SIGNATURE.
- The program staff will measure your height and weight periodically at the park approximately every 3-4 months.
- You will be asked to complete periodic questionnaire surveys in person at the park or by Zoom video call or by phone approximately every 3-4 months. The purpose of the surveys is to assess your physical activity and health related attitudes and behavior. The surveys will take approximately 20 minutes to complete.
- You will be asked to complete periodic interviews in person at the park or by Zoom video call or by phone approximately every 3-4 months. You may participate in the interviews individually or with other 3 WINS Fitness participants. The purpose of the health survey interviews is to obtain your feedback on the 3WINS Fitness program, and assess the impact of the program on your health behavior and outcomes. The interviews will take up to 60 minutes and will be scheduled at a time that is convenient for you.
- You will be asked to provide your contact information (Name, phone number, and email) for the purpose of contacting you to schedule the phone interviews and to receive newsletters. Your contact information will be kept confidential by storing it in a locked file cabinet in the study research office.
Ongoing program
We will be meeting for about 1.3 hours 3 days a week at a designated location. The time will consist of 60 minutes of physical activity and 10-15 minutes of health education at the end of the hour of physical activity.
The physical activity will be conducted in a group setting intended to maintain an elevated heart rate and exercise intensity incorporating aerobic and strength training. Aerobic exercise will be performed at moderate-intensity similar to brisk walking (4 mph/15 minute mile) and progressing to a higher intensity as your fitness improves. Strength training will include the use of body weight or your own weighted backpack exercises with 5-10 exercises for each major muscle group (including upper body, lower body, and core). You will participate in a total body workout that includes modifications specific to your ability. Following the physical activity portion, we will have a voluntary 10-15 minutes of health education including discussion topics revolving around basic nutritional guidelines, physical activity strategies, and behavioral self-management skills. These guidelines will be given to you as an aid to help you achieve your physical activity goal(s) set for this program. You may choose to have an accountability coach, who will 1) meet with you to help you set up your physical activity goals, and 2) regularly follow up with you, monitor your progress in your goal fulfillment, and provide you feedback and suggestions.
What are the risks and discomforts of this program?
The risk for you to participate in this program is minimal. The possible risks and/or discomforts you might experience are fatigue, boredom, dizziness, nausea, heart attack, muscle soreness, strain, sprain, broken bones, and mild dehydration. We plan to minimize these risks by including suitable progressions and modifications to you and providing regular exercise water breaks. In the event that you are injured, 9-1-1 will be called and we will remain with you until help arrives. Any costs incurred are your responsibility.
What are possible benefits for participating in this program?
The possible benefits you may experience from the procedures described in this program include weight loss, decreased Body Mass Index (BMI) values, a positive shift in well-being, improved fitness, better posture and balance, better self-esteem, stronger muscles and bones, feeling more energetic, relaxation and reduced stress, continued independent living in later life, information retention (revolved around basic nutrition, physical activity and behavioral self-management) and a decreased risk of type 2 diabetes (and other related chronic diseases). Additional benefits of the study include learning about the potential for free, park-based physical activity programs to improve the health of individuals and communities. The information will help 3 WINS Fitness understand what makes the program a good experience for people and encourages them to stick with their exercise program.
What are the alternatives to participation?
If you choose to not participate in this 3 WINS Fitness program, there is no other alternative.
What are the costs, reimbursements, and compensation for this program?
You will not be paid for your participation in this program and there is no cost to you. You will not be reimbursed for any out-of-pocket expenses, such as parking, transportation, or any medical costs. For certain questionnaire surveys, you may receive a $10 Target gift card for participation. For certain interviews, you may receive Target gift cards worth $20 for participation..
WITHDRAWAL OR TERMINATION FROM THE STUDY AND CONSEQUENCES
You are free to withdraw from this study at any time. If you decide to withdraw from this study you should notify Steven Loy immediately. The research team may also end your participation in this study if you do not follow instructions or if your safety and welfare are at risk. We will inform you immediately if this occurs.
CONFIDENTIALITY
Your information will be kept confidential by replacing your name with a code. A list linking the code and your identifiable information (e.g. this form) will be stored in a locked file cabinet in a secure faculty office and only the research team on the first page has access to this cabinet. The de-identified research data will be stored electronically on computers with password protection in secure office at all times.
Storage locations for identifiable information and de-identifiable research data are both in the Department of Kinesiology at California State University, Northridge and will be kept for at least 3 years from the date of the end of the program.
Data from the interviews will be recorded on a secure website maintained at CSUN. The website will be password protected. Only the research team will have access to the dataset. Consent forms and participant contact information will be kept confidential by storing it in a locked file cabinet in the study research office. The interview data will not include your name or any personally identifying information. You will be assigned a unique ID code, which will appear with the information you provide in the interview.
Your separate consent will be required to access any information derived from this research project that personally identifies you, except as specifically required by law. Publications and/or presentations that result from this study will not include identifiable information about you.
What if you have questions?
If you have any comments, concerns, or questions regarding the conduct of this research please contact Steven Loy listed on the first page of this form.
Mandated Reporting
Under California law, the researchers are required to report known or reasonably suspected incidents of abuse or neglect of a child, dependent adult or elder, including, but not limited to, physical, sexual, emotional, and financial abuse or neglect. If any researcher has or is given such information in the course of conducting this study, he or she may be required to report it to the authorities.
IF YOU HAVE QUESTIONS
If you have any comments, concerns, or questions regarding the conduct of this research please contact the research team listed on the first page of this form. If you have concerns or complaints about the research study, research team, or questions about your rights as a research participant, please contact the Research and Sponsored Programs office, 18111 Nordhoff Street, California State University, Northridge, Northridge, CA 91330-8232, by phone at (818) 677-2901 or email at irb@csun.edu.
VOLUNTARY PARTICIPATION STATEMENT
You should not endorse this form unless you have read it and been given a copy of it to keep. Participation in this study is voluntary. You may refuse to answer any question or discontinue your involvement at any time without penalty or loss of benefits to which you might otherwise be entitled. Your decision will not affect your relationship with California State University, Northridge. Your endorsement below indicates that you have read the information in this consent form and have had a chance to ask any questions that you have about the study.