Letter of Introduction and Informed Consent

Dear potential research participant,

We are researchers from Burman University, collaborating with One Week in Paradise (OWIP) on a research study examining: The characteristics and outcomes of OWIP participants, and the extent to which the One Week In Paradise program impacts physical/biological, health, and mental health of participants.

Project Title: Impacts of the One Week In Paradise program on physical/biological health indicators, cardiovascular health, gut microbiota, salivary cortisol, IgA, skin conductance, and mental health of participants.

Investigators:

Dr. Heather Gretton

Department: Psychology 

Email Address: heathergretton@burmanu.ca

Dr. Carole Anderson

Department: Psychology

Email Address: caroleanderson@burmanu.ca

Dr. Daniel Saugh

Department: Psychology 

Email Address:

Dr. Pekka Maattenen

Department: Biology

Email Address: pekkamaattanen@burmanu.ca

Department: Psychology 

Email Address: dadrialewis@burmanu.ca

This research study was reviewed by the Ethics Committee at Burman University

We are researching  the characteristics and outcomes of OWIP participants, and impacts of the OWIP program on physical/biological markers, health, and mental health of participants. 

The One Week in Paradise (OWIP) program is an 8 day live-in health and education program with plant-based meals. Participants engage in health consultations and lifestyle medicine-based treatments, with an interdisciplinary team of health care providers, that may include naturopathic doctors,  a medical doctor, a personal trainer, registered massage therapist, pharmacist, nutritionists, psychologist and/or mental health counselors.  OWIP program participants are asked to visit a doctor or have blood tested within one week before the program begins, to measure blood pressure, cardiovascular and other disease risk factors, and body mass index (BMI). They may also be asked to follow up with a health professional, and to repeat the physical/biological and mental health measures within 8 weeks following the program.We invite you to take part in this study. You have received this consent form because you are enrolled in the OWIP program or are considering enrollment in the program. 

Should you decide to participate in the research, we will ask you to provide and/or complete following:

• Access to your personal and health information,  history and measurements, before, during, post OWIP, and in the 8 weeks following the OWIP program. 

• A small saliva and stool sample at the beginning and end of OWIP. We may also ask you to collect another sample in the 8 week follow up period, when you have your final blood test.

•  You will be given simple instructions on collecting the stool and saliva samples. These will be submitted for storage and analysis. You will be asked to recall 3 days of foods consumed (breakfast, lunch, and dinner) prior to the program, and before your final stool collection and blood test.

• Mental health questionnaires, prior to and at the end of OWIP,  and after 8 weeks. These questionnaires can be completed online or by paper and take approximately 15-40 minutes. 

• If time permits you may be invited to participate in a pre and post program interview to share your presenting  issues and goals for the program, your experiences of the program, accomplishments, challenges, and what you hope to take with you from the program. If you agree,  this interview will be video/audio-recorded, for future analysis. 

As a research participant, you will also be asked to apply the principles you learn in the OWIP program to the best of your ability throughout your 8-day experience, and over the 8 week follow up, and record a daily checklist of certain diet and habits including hours of sleep, exercise, deep breathing, avoiding negative speech, cups of water and other lifestyle habits. Any major diet or lifestyle changes you make in response to this program should be done in consultation with your family physician.

Risks and discomforts: Please advise the OWIP program staff of any food allergies and your diet can be adjusted accordingly. The plant-based diet recommended in the program is generally higher in fiber than the standard North American diet. Side effects, such as bloating and gas,  may occur when increasing fiber in your diet.  Increasing water intake is important when adding fiber to your diet, to help alleviate possible side effects. If you experience discomfort, please report this to your OWIP doctor, and let the study coordinators know.

The OWIP program involves physical activity that comes with potential risks during participation (e.g. episodes of transient lightheadedness, loss of consciousness, abnormal blood pressure, chest discomfort, leg cramps, nausea). If you experience any pain, discomfort, fatigue or any other symptoms during and after your participation please inform your OWIP health care provider  immediately.

When completing questionnaires and interviews, thoughts and feelings may emerge, like those in day-to-day reflection. If you wish to withdraw, you are free to do so at any time. We welcome your feedback and invite you to contact the researchers for any debriefing, feedback, support and follow-up, as needed.

Data security and confidentiality: Data will be collected and stored according to the Personal Health Information Protection Act.  No identifying information will be shared with anyone outside the core research team and research assistants, unless required by law. Data from doctor’s reports that include your name (from your doctor’s visit) will be kept in a locked drawer/encrypted file folder. To prepare for analyses, data will be transferred to a separate data file that will be scrubbed and anonymized for analysis, with a code corresponding with your name. Only the investigators and research assistants will have access to the code. The data will form part of an ongoing database for present and future analyses and studies. Individual quotes from interviews may be used in research presentations or papers. For your privacy and protection, these will be anonymized using a pseudonym.  Consent forms will be stored separately and destroyed when legally permissible. 

Benefits of the research and benefits to you:  There is no guarantee that you will benefit directly from participating in this study. There will be no monetary compensation for your participation.  However, your participation will contribute to a body of research on the characteristics and outcomes of participants who engage in OWIP and similar lifestyle medicine and health-based programs. This will help with the development and improvement of future programs. As a participant, you are welcome to contact the researchers at any point in time if you wish to discuss the progress of the study.  

Voluntary participation: Your participation in the research is completely voluntary and you may be part of the OWIP program without being part of the research. You may also choose to stop participating at any time. Your decision to not continue participating will not influence your relationship with the OWIP Program staff or researchers at Burman University either now or in the future. If you withdraw from the study, all associated data collected will be immediately destroyed wherever possible.

If you have further questions regarding any aspect of the research study, please contact Pekka Määttänen at 1 403-782-3381 ext. 4186 (office) or 1 647-772-5991 (cell) or Daniel Cho (289-763-5994; owip@paradisehealth.ca) .