INTRODUCTION
You are invited to participate in a health literacy assessment and evaluation project by Cherise B. Harrington, PhD, MPH, Professor, North Carolina Central University.
This study involves research. You are being asked if you want to participate in this project because you are a student at North Carolina Central University. Details about this study are discussed below. It is important that you understand this information to make an informed choice about whether you want to participate in this research. Would you please read this form and ask us any questions that will help you decide if you want to be in the project? Taking part is completely voluntary, and even if you decide you want to, you can quit at any time.
You must be at least 18 years old to take part in this study.
You are 1 of 475 people taking part in this intervention portion of the BeFAB-HBCU project that includes assessing health and weight resources and barriers.
PURPOSE
This project aims to understand the weight and physical activity health needs of North Carolina Central University (NCCU) students. Your participation will help identify the best programs, services, and approaches to address the weight and physical activity health of NCCU students. You will be asked questions about your health, resources, barriers, and your opinion about weight-based programs in your area.
PROCEDURES
If you choose to participate in this research, you will be randomly assigned to either the BeFAB-lite (delayed attention waitlist control) group or the BeFAB-HBCU (treatment) group. If assigned to BeFAB-HBCU, you will also be asked to participate in the intervention which is available through a downloadable mobile app or through a web platform.
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Review of Informed Consent (5-minute duration)
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Participation in Intervention (12 weeks, with a delayed/maintenance 12-week participation for BeFAB-lite group). Minimum engagement estimated to be approximately 6-12 hours over 24 weeks (~15-30 minutes a week).
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Possible engagement:Review weekly newsletters, goal setting, logging progress, watching videos and reviewing messaging, attending campus fitness and nutrition events, and sharing your progress through regular survey-based assessments.
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Assessments:
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Baseline Time 1 - Attend a public launch event or individual appointment to complete baseline assessment (survey and biometrics) and introduction to the application and website.
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Midpoint Time 2 (week 6) - Complete survey and biometric assessments (public event and individual appointments possible).
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Follow-up Time 3 (week 12) – Complete survey and biometric assessments.
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Weekly short check-in - 5 item questionnaires
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Optional: Biomarker and Accelerometer assessments.
Expected Time commitment for Assessments:
— Online surveys
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Week 1 - Baseline 88-item – 15-minutes
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Week 6 - Midpoint 81-item – 15-minutes
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Week 12 - Final 84-item – 15-minutes
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Week 18 – Maintenance-1 50-item 1 – 15-minutes
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Week 24 – Maintenance-2/Final - 50-item – 15-minutes
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12 - 5-item weekly evaluations– 1-minute each
— Weight/height measurements – 5 minutes at Weeks 1, 6, 12, 18, 24
BeFAB-HBCU (Treatment):
This group will be asked to download and engage with weekly content over 24 weeks (12-week intervention, 12-week maintenance phase). During the introductory period and baseline data collection, participants will explore the program’s interface, navigate through various components, and watch an introductory video that provides an overview of the program and encourages participation.
BeFAB-lite (Delayed Attention Waitlist Control):
This group is a delayed attention control, meaning you will receive key introduction health behavior information weekly for 12-weeks, plus the opportunity to engage in community events. After 12-weeks, Group 2 will then have access to the full intervention for 12 weeks.
RISKS & CONFIDENTIALITY
The risks and discomforts involved in this study are believed to be minimal. The study has the following risks:
You may feel some emotional stress/discomfort answering the intervention questions. You will be asked questions about weight and physical activity priorities, health resources, and barriers.
You are free to skip any questions or stop engaging with the intervention at any point. If you feel the need to talk to someone about your emotions, don't hesitate to get in touch with Cherise Harrington at 919-530-7130, who will provide you with contact information for professional services.
There is a chance that someone not on our research team could find out that you took part in the study or somehow connect your name with the information we collect about you; however, the following steps are being taken to reduce this risk: 1. your name will not be associated with your survey responses, 2. your name, which again will only be collected for tracking purposes will be stored in a separate, secure location; identifying data will be destroyed after 12-months.
The records of this study will be kept private. In any published articles or presentations, we will not include any information that will make it possible to identify you as a subject.
Your records for the study may be reviewed by the North Carolina Central University departments responsible for overseeing research safety and compliance.
The likelihood of any serious problem is believed to be low.
BENEFITS
This research will not help you directly; however, the benefit to society will be a better understanding of weight and physical activity health needs and barriers of NCCU students.
Right to Refuse or Withdraw from the Study:
Your participation in this study is voluntary. You may refuse to participate or may discontinue your participation at any time without penalty. The Investigator has the right to stop your participation at any time.
Use of Research Results:
The data obtained in this study will assist investigators in understanding the physical activity and weight needs North Carolina students. The data may be used in publications or for teaching purposes.
COSTS and COMPENSATION
Incentives – Participants will receive $20 for each completed baseline, midpoint at 6-weeks, and final at 12-weeks.
Incentives Biomarkers Assessment – 10% of participants will be asked to volunteer for additional biomarker assessments, including salivary cortisol and hemoglobin to assess C-Reactive Protein (CRP) to assess inflammation, Lipids to assess cholesterol levels, and hemoglobin A1c (HbA1c) to assess glucose metabolism. Participants will receive an additional $50 for providing biomarker data. Time estimate 30 minutes at Weeks 1, 6, and 12.
Incentives for Personal Wearable – 20% of participants will be recruited and asked to wear have their personal wearable linked to the app and their activity monitored over the 12-week intervention timeline. Participants will receive an additional $50 for providing biomarker data.
Prizes - You may receive small prizes and gifts for interacting with study materials. Additional incentives, such as raffle prizes and bonuses for completing follow-up visits, will be provided to help maximize retention.
QUESTIONS
If you have any questions, complaints, or concerns about this study, you can contact the Principal Investigator listed at the top of this form at 919-530-7130. This study has been approved by the Institutional Review Board (IRB) at North Carolina Central University. If you have questions about your rights as a research participant or have complaints or concerns about this study, you may contact the NCCU IRB at IRB@NCCU.EDU.
Title of Study:
Multi-dimensional Approach to Address Excess Weight and Pre-Diabetic Health Disparities in Young Adults: BeFAB-HBCU
Principal Investigator:
Cherise B. Harrington, PhD, MPH
Participant's Agreement:
I have read the information provided above and voluntarily agree to participate in this study. My signature certifies that I am 18 years of age or older.
Printed Name of Research Participant
Signature of Research Participant
INVESTIGATOR STATEMENT
I certify that the research study has been explained to the above individual by my research staff, including the purpose, procedures, possible risks, and potential benefits of participation in this research study. Any questions raised have been answered to the individual's satisfaction.
