It’s actually doing the real study, need to be feasible on college, one person level and then pretend that I did the study.
- Specific what qualitative design I am doing.
- APA format.
- Follow the example on the document attached.
Sample Study Protocol
Smoking among ambulance personnel
Background
Cardiovascular diseases are a major problem in the US. In 2006, approximately eighty million people have one or more forms of cardiovascular disease (CVD), including high blood pressure, stroke, coronary heart disease (myocardial infarction, angina), and heart failure (AHA, 2009). Death from CVDs represents over 35% of all deaths in this country. Many factors increase someone’s risks of developing a cardiovascular disease, including smoking, family history, age, diabetes, physical inactivity, high cholesterol, and obesity. Ambulance personnel, also called Emergency Medical Technicians (EMTs), respond everyday to 911 calls involving people with all kind of emergencies including cardiovascular diseases and complications. Intense daily exposure to stressful emergencies puts EMTs at high risk of maladaptive reactions like; illness, depression, and impaired performance ADDIN EN.CITE (Boudreaux, Jones, Mandry, & Brantley, 1996) . And one consequence of intense and continuous stress is an increase in smoking (Pomerleau & Pomerleau, 1991).
However, due to their knowledge of health risks associated with smoking, one would expect that smoking behavior would be lower among such a group compared to the general US population, but it not (Pirrallo, Levine, & Dickison, 2005). Therefore, in this study, our objectives are to determine; 1) what EMTs know about health risks and consequences associated with smoking, 2) How they perceive their daily job stress as factor influencing smoking habits, 3) what other factors influence smoking behavior among EMTs beside job related stress.
Study Design
This is a cross-sectional qualitative study design with a phenomenological approach.
Sample
For this study, since I will explore EMTs perception and experience on smoking, I plan on interviewing enough participants until I reach saturation. Ideally, this could require 12 to 18 participants. However, due to the time restraints associated with this study, I will use a small sample size of three.
· Target population: Emergency Medical Technicians living in Georgia
· Inclusion criteria; be 18 years old or older, males or females , hold a current EMT certification, be a smoker.
· Exclusion criteria; not holding a current EMT card, less than 18 years old, not living in Georgia
Setting
The location of study procedures and data collection will be the respondent’s workplace. I plan on interviewing them at EMS station 8 in Marrietta, GA.
Recruitment
I will conveniently choose one ambulance company, the Metro Atlanta Ambulance Services (MAAS). Then, I will invite three EMTs who smoke to participate in the study after explaining to them what the study is about.
Procedures
I will be conducting three in-depth interviews. The interaction with the participant will be an oral interview about smoking among EMTs. The interview will take place at the participant’s workplace, will be recorded, and will be administered by the researcher. No other interactions (MRI, cognitive testing, and experimental procedures) will take place in this study. Each respondent will be in the study for about half an hour; just the time needed to be informed about the study and to answer the questionnaire.
Measures
A questionnaire developed by the researcher will be used to learn; what EMTs know about health risks and consequences associated with smoking; how they perceive their daily job stress as factor influencing smoking habits; and what other factors influence smoking behavior among them beside job related stress.
Risks to participation
There are no foreseeable risks or discomfort associated with this study.
Benefits to subject or future benefits
There are no direct benefits to study subjects. However, the findings will add to the knowledge about factors that influence EMTs to smoke, and will help create interventions to decrease smoking behavior among EMTs.
Data analysis
Interview data will be analyzed using the qualitative software package called MaxQDA, version 3.4.5.
Training for research personnel
No personnel training is required. The researcher will conduct the interviews, record, and do a verbatim transcription of the audio content of the interviews.
Plans for data management and monitoring
The questionnaire will not include name, only an interview numbers. All recorded answers and field notes will be transferred to the researcher’s laptop and will be password protected. They will also be backed up on an external drive. Only the researcher will have access to the laptop and the back-up drive.
Confidentiality
No medical records or photos data will be collected or stored. The questionnaire (field notes) will not include name but only an interview number. All answers will be transferred from the questionnaire form to the researcher’s laptop and will be password protected. Only the researcher will have access to the laptop and back-up drive. Once the original forms have been processed and checked, all forms will be destroyed. Until they are destroyed, they will be stored in a locked file, accessible only to the researcher. The voice data will be saved on the researcher’s computer and be password protected. They will be destroyed after transcription and analysis
Informed consent
At the respondent’s workplace, the qualified EMT who agrees to participate will be given another explanation of the study, then he will be given the consent form to read and to sign if he still agrees to participate, I will informed the participants at the end of the study about the findings
References
http://www.americanheart.org/presenter.jhtml?identifier=4478AHA (2009). Cardiovascular Disease Statistics, from
Boudreaux, E., Jones, G. N., Mandry, C., & Brantley, P. J. (1996). Patient care and daily stress among emergency medical technicians
The effects of stressors on emergency medical technicians (Part II): A critical review of the literature, and a call for further research
Sources of stress among emergency medical technicians (Part I): What does the research say? Prehosp Disaster Med, 11(3), 188-193; discussion 193-184.
Pirrallo, R. G., Levine, R., & Dickison, P. D. (2005). Behavioral health risk factors of United States emergency medical technicians: the LEADS Project. Prehosp Disaster Med, 20(4), 235-242.
Pomerleau, O. F., & Pomerleau, C. S. (1991). Research on stress and smoking: progress and problems. British Journal of Addiction, 86(5), 599-603.
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Andrews University
School of Health Professions FDNT 560-‐999: Health Research Methods
Class Instructor: Dr. Maximino Mejia, DrPh, MS, RD
A Lifestyle Intervention Comparison: Does the addition of the portfolio diet to a total vegetarian
diet and physical activity intervention improve selected markers of metabolic syndrome in Scandinavian women?
By Theresa Nybo Jakobsen
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Abstract Background: Metabolic syndrome has become a worldwide problem reaching a prevalence of 25%. Though there is an agreement that lifestyle changes are the first-‐line approach, there is not a consensus as to which type of diet and lifestyle is most effective. The purpose of this study is to compare the effect of the addition of the portfolio diet to a total vegetarian diet on metabolic syndrome risk factors within Scandinavian women in a 12-‐day lifestyle intervention. Methods: A 12-‐day, pre-‐post randomized, test control group design will be used. The subjects, 34 female guests at the Fredheim Health Center, will be randomly assigned to either the experimental group, total vegetarian diet and exercise intervention with the addition of the elements of the portfolio diet, or the control group, a total vegetarian diet and exercise intervention. Hypothesis: Our hypothesis is that a total vegetarian diet will effectively reduce metabolic syndrome risk factors in this population and that the addition of the four elements of the portfolio diet will further reduce these risk factors.
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Table of Contents
ABSTRACT 2
TABLE OF CONTENTS 3
INTRODUCTION 4
LITERATURE REVIEW 4
MATERIALS AND METHODS 6
EXPERIMENTAL UNITS 6 INCLUSION CRITERIA 6 EXCLUSION CRITERIA 6 SAMPLING METHOD 6 SAMPLE SIZE 7
RESEARCH DESIGN 7 TYPE OF RESEARCH DESIGN 7 DIET 7 EXERCISE 7 VARIABLES 7 INSTRUMENTS AND DATA COLLECTION SYSTEMS 8 STATISTICAL ANALYSIS 8 RISKS 8 BENEFITS 8 CONFIDENTIALITY 8 TIMELINE 8 BUDGET 8 ETHICS REVIEW 9 INCENTIVES 9
CONCLUSION 9
TABLES 10
TABLE 1: INDEPENDENT VARIABLES 10 TABLE 2: DEPENDENT VARIABLES 10 TABLE 3: CONFOUNDING VARIABLES 11 TABLE 4: TIMELINE 11 TABLE 5: BUDGET 12
APPENDIX 13
APPENDIX 1: INFORMED CONSENT FORM 13
REFERENCES 19
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Introduction Metabolic syndrome (MetS) has become a worldwide problem with prevalence rates of up to 84% in some countries (as cited by Kaur, 2014). It presents serious health risk problems (IDF, 2014; Grundy et al, 2004) and carries considerable economic costs (Bourdreau et al., 2009). Diet and lifestyle changes are the chosen treatment plan (Gurndy et al., 2004, NIH, 2011), but there is not a unity as to which diet or lifestyle presents the best results (Zivkovic, German and Sanyal, 2007). Previous studies have shown positive results with the use of a short-‐term plant-‐based diet and exercise for MetS markers (Macknin et al., 2014; Balliett & Burke, 2013; Chen, Roberts & Barnard, 2006; Sullivan & Klein, 2006). Additionally, a dietary portfolio of cholesterol lowering foods has presented promise for cardiovascular disease (CVD) risk factors (Jenkins, et al., 2003; Jenkins, et al., 2011). Therefore the purpose of this study is to compare the effect of the addition of the portfolio diet to a total vegetarian diet on metabolic syndrome risk factors within Scandinavian women in a 12-‐day lifestyle intervention. The objective is to determine if the portfolio diet elements incorporated into a total vegetarian diet and exercise intervention gives greater improvements than a total vegetarian diet and exercise intervention alone on metabolic syndrome risk factors. Our hypothesis is that a total vegetarian diet will effectively reduce metabolic syndrome risk factors in this population and that the addition of the four elements of the portfolio diet will further reduce these risk factors.
Literature Review MetS is a multifaceted risk factor for cardiovascular disease, as well as type 2 diabetes (T2D) (Grundy, Brewer, Cleeman, Smith, & Lenfant, 2004). This syndrome represents serious health risks. According to Alberti et al. (2009), MetS presents a 5-‐fold increase in the risk of T2D and a 2-‐fold increase in the risk of CVD within 5 to 10 years compared with individuals not having MetS. Additionally, those with MetS have a risk of dying from heart attack or stroke that is twice that of those without MetS and they are three times as likely to have a heart attack or stroke in the first place (International Diabetes Federation [IDF], 2014). Furthermore, there are other conditions that present themselves more often in those with MetS, namely: polycystic ovary syndrome, fatty liver, cholesterol gallstones, asthma, sleep disturbances, as well as some forms of cancer (Grundy et al., 2004). MetS is a cluster of different risk factors that occur simultaneously. Though there are several different variations of a definition for MetS given by different organizations, all agree that there are five components that constitute the syndrome (Kaur, 2014). These are: central obesity (increased waist circumference), elevated triglycerides, reduced HDL cholesterol, elevated blood pressure, and elevated fasting glucose (Alberti et al., 2009). A commonly used definition in clinical practice is the National Cholesterol Education Program Adult Treatment Panel III (ATP III). The ATP III classifies individuals as having MetS when they have at least three out of the five above-‐mentioned components (Alberti et al., 2009). Another internationally recognized
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definition is given by the International Diabetes Federation (IDF). This definition requires that an individual must have central obesity, plus any two of the four remaining factors (IDF, 2006). MetS has become a worldwide problem. The prevalence of MetS ranges from less than 10% to up around 84% in the different regions of the world, depending on the diagnostic criteria used (as cited by Kaur, 2014). On a worldwide basis according to the IDF about 25% of the population has MetS (IDF, 2014). Looking more locally, a study from 2007 found that the prevalence of MetS in Norway was 29.6% using the IDF definition or 25.9% using the ATP III definition (Hildrum, Mykletun, Hole, Midthjell, & Dahl, 2007). Either percentage represents a serious health problem that needs to be addressed. Additionally, the prevalence of MetS increases with age (Hidlrum et al., 2007). With an increasingly aging population, the prevalence of MetS can only be expected to increase. The economic burden that MetS presents is substantial. As MetS is a cluster of components, each component adds its burden to the increased risk for future health care costs (Nichols & Moler, 2011). Overall, Bourdreau et al. (2009) found that healthcare costs increased by 24% with the addition of each component of the MetS. Additionally, individuals with MetS had a statistically higher usage and cost for health care services than those without (Bourdreau et al., 2009). The average annual cost in the US for those with MetS was 1.6 greater than those not having the syndrome (Bourdreau et al., 2009). Looking at several of the individual components of MetS or related problems, we can get a better understanding of the global costs. Gaziano, Bitton, Anand, Weinstein and the International Society of Hypertension (2009) found that globally the direct cost of hypertension in 2001 was $370 billion. They further estimated that over a 10-‐year period this amount could rise to $1.0 trillion and with the addition of all indirect costs adding up to a whopping $3.6 trillion (Gaziano et al., 2009). Though not specifically abdominal obesity, the global economic cost for caring for all types of obesity is an incredible $2.0 trillion (Dobbs et al., 2014). According to the IDF (2013), global spending to treat and manage diabetes in 2013 was $548 billion and this figure is expected to rise to over $627 billion by 2035. Prediabetes or elevated fasting glucose levels, a component of MetS, comes to a cost of $44 billion in the US alone, according to a press release from the American Diabetes Association (Trimble, 2014). These figures represent a considerable economic cost for MetS. The increased health risk factors, the existing health problems and the financial burden of MetS cry out for a solution for this public health problem. According to conference participants from the National Heart, Lung, and Blood Institute/American Heart Association Conference of 2004, “therapeutic lifestyle change, with emphasis on weight reduction, constitutes first-‐line therapy for metabolic syndrome” (Grundy et al., 2004, p. 438). The NIH is in agreement with this and states that aggressive lifestyle changes include weight loss, dietary improvement, physical activity and smoking cessation (NIH, 2011). If lifestyle changes are insufficient, medicines may be prescribed to control one or more of the different components of MetS (NIH, 2011). However, lifestyle changes are both cost-‐effective and relatively simple to perform.
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Unfortunately, according to Zivkovic, German and Sanyal (2007) there is no consensus as to the best diet or lifestyle approach to prevent or treat MetS and further study needs to be done. One dietary approach that presents several promising aspects for MetS is a whole-‐food, plant-‐ based diet. This type of diet emphasizes eating unrefined plant foods such as fruits, vegetables, legumes, seeds and nuts, while limiting or eliminating animal products and refined, processed foods (Tuso, Ismail, Ha & Bartolotto, 2013). This type of diet can be found in a well-‐balanced vegetarian or vegan diet. Well-‐balanced vegetarian diets provide high quality nutrition while being low in energy (Clarys et al, 2014; Turner-‐McGrievy & Harris, 2014) and they tend to have a high level of satiety similar to that of animal origin (Neacsu, Fyfe, Horgan & Johnstone, 2014). Additionally, Lea, Crawford and Worsley (2006) found that the perceived barriers to eating a plant-‐based diet were low. These features make adoption and sustainability of this type of dietary easier and suitable to be used in interventions for MetS. Another dietary approach, focusing specifically on the CVD risk factors of MetS, is the dietary portfolio of cholesterol lowering foods or the portfolio diet (Jenkins, et al., 2003, Jenkins, et al., 2011). This diet includes cholesterol-‐lowering foods that are recommended by the US Food and Drug Administration (Jenkins, et al., 2011). Specifically, these foods are plant sterols, soy proteins, viscous fibers and nuts (Jenkins, et al., 2011).
Materials and Methods
Experimental Units The experimental units in this study will be patients at the Fredheim Health Center in Kongsberg, Norway, taken over 10 health sessions.
Inclusion criteria Women Age: 65+ BMI: 25 -‐ 45
Exclusion criteria Allergy to nuts or any other component of the intervention diets Taking antihypertensive medication Taking cholesterol reducing medication Taking diabetes medication
Sampling Method Patients will be randomly assigned to the total vegetarian diet and exercise program, control group, or the total vegetarian diet and exercise program with the addition of the portfolio diet, experimental group.
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Sample Size A sample size was calculated using G*Power 3.1. A F-‐test, ANOVA: Repeated measures, within-‐ between interaction was used. The effect size used is a medium size, 25%; the alpha error probability used is 5%; and the Power (1-‐beta error probability used is 80%.
Research Design
Type of Research Design A 12-‐day, pre-‐post randomized, test control group design will be used. The subjects will be randomly assigned to either the experimental group or the control group.
Diet The total vegetarian diet (~60% of calories from carbohydrates, 15% protein, and 25% fat) will consist of whole grains, legumes, vegetables, fruits, nuts and seeds. Animal products will not be served. The Portfolio diet will contain the same elements of the total vegetarian diet (~60% of energy from carbohydrates, 15% protein and 25% fat) with the incorporation of the following elements: 0.94 g of plant sterols per 1000 kcal of diet in a plant sterol ester–enriched margarine, 22.5 g of soy protein per 1000 kcal as soymilk, tofu, and soy meat analogues, 9.8 g of viscous fibers per 1000 kcal of diet from oats, barley, and psyllium, and 22.5 g of nuts (including tree nuts and peanuts) per 1000 kcal of diet. All food will be provided by the Fredheim Health Center and records will be kept for each participant’s food consumption in a daily dietary record.
Exercise Arranged walk/hikes or cross-‐country ski trips (depending on the time of year) for between 1 – 1.5 hours will be arranged 6 days per week. Morning gymnastics for 30 minutes will be arranged 5 days a week and an afternoon chair gymnastics of 30 minutes for 2 days a week. Additionally participants will be encouraged to walk after every meal. Physical activity will be assessed by pedometer (Omrom, Kyoto, Japan) and records kept of participation in all arranged physical activities.
Variables The following independent variables will be used in this study: control diet and experimental diet. See Table 1: Independent Variables. The following dependent variables will be used: metabolic syndrome diagnosis, weight, BMI, waist circumference, tryglycerides, HDL cholesterol, LDL cholesterol, total cholesterol, blood pressure, blood glucose, HbA1c. See Table 2: Dependent Variables. This study also has confounding variables, which are controlled for in the research design. They are as follows: gender, age, antihypertensive medication, anti-‐ hyperlipidemia medication, and diabetes medication. See Table 3: Confounding Variables.
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Instruments and data collection systems All measures will be performed on day 2 of the program (Monday morning after arrival) and on day 12 (Friday morning prior to departure) after 10-‐ to 12-‐h overnight fasting with only tap water allowed ad libitum. Weight will be measured using a periodically calibrated scale accurate to 0.1 kg with participants in light clothing and no shoes. Height will be measured using a standard measuring tape and the participant will have no shoes. Body mass index will be calculated from measured body weight and height (kg/m2). Waist circumference will be measured using a tape measure placed at the midpoint between the lowest rib and the upper part of the iliac bone. Blood pressure and heart rate will be measured after participants have rested 5 minutes using a digital blood pressure monitor (Omron, Kyoto, Japan). Three measurements will be taken 2 minutes apart. The first measurement will be disregarded and a mean value will be calculated for the remaining two measurements. All laboratory measurements will be taken according to standard techniques and processed at Fürst Medisinsk Laboratorium, Oslo, Norway.
Statistical analysis Repeated measures MANOVA models with between-‐subject and within-‐subject factors and interactions will be used. Data will be organized and cleaned using Microsoft Excel for Mac software. Statistical analysis will be performed using SPSS 23 for Mac software (SPSS Inc., Chicago, IL, USA). A P value of less than 0.05 will be considered statistically significant.
Risks There are no anticipated risks to the participants with this intervention, aside from the risk of unknown food allergies. In the event of a participant manifesting a food allergy, appropriate medical attention will be provided.
Benefits This study will enhance human knowledge by providing additional information on the effects of lifestyle interventions for metabolic syndrome.
Confidentiality So as to insure confidentiality, all data collected will be numerically coded and all personal identifiers will be removed. The data will be securely stored with password protection on all files. Only the researcher and those assisting with statistical analysis will have access to the coded data.
Timeline This study is calculated to take 16 months to complete. This time period could be shorter or longer depending on the amount of time needed for approval from the appropriate ethics review board. See Table 4: Timeline.
Budget This research study is budgeted to cost 502 000 Swedish crowns. Grants and donations will be sought to cover the majority of this budget. See Table 5: Budget.
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Ethics Review This study protocol will be submitted to the appropriate ethics review board, prior to implementation. Informed voluntary consent will be obtained from each participant prior to participation. The informed consent form is adapted from WHO templates for informed consent (WHO, 2015). See Appendix 1: Informed Consent Form. These informed consent forms will be kept by the researcher in a locked cabinet for a minimum of three years.
Incentives Incentives in the form of free pre and post blood testing will be offered each participant in this study.
Conclusion It is expected that the results of this study will support our hypothesis that significant changes can be made in MetS markers as a result of a short-‐term total vegetarian diet and exercise intervention among a population of Scandinavian women. Additional improvements are expected in those women consuming the additional elements of the portfolio diet. Therefore, this could be a very promising, economical program for MetS treatment.
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Tables
Table 1: Independent Variables Variable Type Measured Measurement
Control Diet Continuous Detailed menus with recipes and food consumed diaries
% fat, protein, carbohydrates
Experimental Diet Continuous Detailed menus with recipes and food consumed diaries
% fat, protein, carbohydrates
Table 2: Dependent Variables Variable Type Measured Measurement
Metabolic syndrome diagnosis
Binomial National Cholesterol Education Program Adult Treatment Panel III (ATP III)
Number of components of MetS
Weight Continuous Calibrated scale accurate to 0.1 kg Kg BMI Continuous Calculated from measured body weight and height kg/m2 Waist circumference Continuous Tape measure placed at the midpoint between the
lowest rib and the upper part of the iliac bone cm
Triglycerides Continuous Taken according to standard techniques and processed at Fürst Medisinsk Laboratorium, Oslo, Norway
mmol/L
HDL cholesterol Continuous Taken according to standard techniques and processed at Fürst Medisinsk Laboratorium, Oslo, Norway
mmol/L
LDL cholesterol Continuous Taken according to standard techniques and processed at Fürst Medisinsk Laboratorium, Oslo, Norway
mmol/L
Total cholesterol Continuous Taken according to standard techniques and processed at Fürst Medisinsk Laboratorium, Oslo, Norway
mmol/L
Blood pressure Continuous After participants have rested 5 minutes using a digital blood pressure monitor (Omron, Kyoto, Japan). Three measurements will be taken 2 minutes apart. The first measurement will be disregarded and a mean value will be calculated for the remaining two measurements
mm Hg
Blood glucose Continuous Taken according to standard techniques and processed at Fürst Medisinsk Laboratorium, Oslo, Norway
mmol/L
HbA1c Continuous Taken according to standard techniques and processed at Fürst Medisinsk Laboratorium, Oslo, Norway
%
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Table 3: Confounding Variables Variable Type Measured Rationale Controlled Eliminated
Gender Binomial Medical Record Men and women have different risks for MetS and could react differently to the intervention
Research design
Only women will be part of this study
Age Continuous Medical record Pre-‐menopausal women and post-‐menopausal women have different risk factors for CVD and could react differently to the intervention
Research design
Only women older than 65 (after menopause) will be part of this study
Antihypertensive medication
Binomial Medical Record Medication could influence the results
Research design
Excluded from study
Cholesterol reducing medication
Binomial Medical Record Medication could influence the results
Research design
Excluded from study
Diabetes medication Binomial Medical Record Medication could influence the results
Research design
Excluded from study
Table 4: Timeline Time Allotted Starting Dates Process Dates Specific Responsible
4 months September 2015 Ethics Review August 26, 2015
Protocol turned in to appropriate ethics review board
Researcher
8 months January 2016 Recruit and Collect Data
January 4 – 8, 2016
Assist in establishing data collection protocols
Researcher
January 4, 2016 – July 31, 2016
Collection of data Fredheim staff
April 11 – 13, 2016
Midpoint check on data collection
Researcher
August 1 – 3, 2016
Final check on data collection
Researcher
1 month August 2015 Enter & Clean Data August 4 – 10, 2016
Entering data / double data entry
Researcher
August 11 – 31, 2016
Cleaning data Researcher
1 month September 2016 Analyze Data September 1 – 30, 2016
Analyze Data Researcher & Statistician
2 months October 2016 Write and Report October 3 – 31, 2016
Write Report Researcher
16 months TOTAL
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Table 5: Budget Cost per patient /
unit Amount Committed Requested Provider
Blood Tests (40 patients) 2 400 sek 96 000 sek 96 000 sek Grant
Additional food Required (40 patients)
1 000 sek 40 000 sek 40 000 sek Grant
Researcher travel costs (3 trips)
10 000 sek 30 000 sek 30 000 sek Grant
Intervention 11 000 sek 440 000 sek 440 000 sek Fredheim Patients
Researcher Salary (16 months x 20 hours / month)
16 000 sek 256 000 sek 256 000 sek Grant
Office Space & Materials Computer/Phone
5 000 sek 80 000 sek 80 000 sek Grant
Total Requested 502 000 sek Grant
Abbreviations: sek = Swedish kronor, ~8 sek = ~1 USD
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Appendix
Appendix 1: Informed Consent Form
Informed Consent form for women patients at the Fredheim Health Center who are invited to participate in research on metabolic syndrome.
The title of our research project is “Does the addition of the portfolio diet to a total vegetarian diet and physical activity intervention improve selected markers of metabolic syndrome in Scandinavian women?” Researcher: Theresa Nybo Jakobsen, MPH Organization: LifeStyleTV, Fredheim Health Center Sponsor: Grant provider Proposal: “Does the addition of the portfolio diet to a total vegetarian diet and physical activity intervention improve selected markers of metabolic syndrome in Scandinavian women?” This Informed Consent Form has two parts:
• Information Sheet (to share information about the research with you) • Certificate of Consent (for signatures if you agree to take part)
You will be given a copy of the full Informed Consent Form
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PART I: Information Sheet A. Introduction LifeStyleTV in conjunction with Fredheim Health Center are conducting research on the risk factors for the metabolic syndrome. We will provide you with information and invite you to be part of this research. You are free to talk with anyone you wish before you decide to participate. There may be some words that you do not understand. Please ask to stop as we go through the information and an explanation will be given. If you have questions later, you can ask them the staff. Purpose of the research Metabolic syndrome has become a worldwide problem with prevalence rates of up to 84% in some countries (as cited by Kaur, 2014). It presents serious health risk problems (IDF, 2014; Grundy et al, 2004) and carries considerable economic costs (Bourdreau et al., 2009). Diet and lifestyle changes are the chosen treatment plan (Gurndy et al., 2004, NIH, 2011), but there is not a unity as to which diet or lifestyle presents the best results (Zivkovic, German and Sanyal, 2007). Previous studies have shown positive results with the use of a plant-‐based diet and exercise for the components of metabolic syndrome (Macknin et al., 2014; Balliett & Burke, 2013; Chen, Roberts & Barnard, 2006; Sullivan & Klein, 2006). Additionally, a dietary portfolio of cholesterol lowering foods has presented promise for cardiovascular disease risk factors, one particular component of metabolic syndrome (Jenkins, et al., 2003; Jenkins, et al., 2011). Therefore the purpose of this study is to compare the effect of the addition of the portfolio diet to a total vegetarian diet on metabolic syndrome risk factors within Scandinavian women in a 12-‐day lifestyle program. The objective is to determine if the portfolio diet gives greater improvements than a total vegetarian diet and exercise alone on metabolic syndrome risk factors. Type of Research Intervention This research will include the total vegetarian diet offered at Fredheim, including four components of the portfolio diet. Plant sterols such as a plant sterol ester–enriched margarine Soy protein such as soymilk, tofu, and soy meat analogues Viscous fibers such as oats, barley, and psyllium Nuts (including tree nuts and peanuts) Participant selection We are inviting all women attending Fredheim Health Center during this session to participate in this research on metabolic syndrome.
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Voluntary Participation Your participation in this research is entirely voluntary. It is your choice whether to participate or not. Whether you choose to participate or not, all the services you receive at Fredheim will continue and nothing will change. If you choose not to participate in this research project, you will be offered the treatment that is routinely offered at Fredheim. You may change your mind later and stop participating even if you agreed earlier. Information on the Portfolio Diet The lifestyle program we are testing in this research is called the portfolio diet. It has been tested before with people with high blood lipids or fats. We now want to test this diet in combination with a total vegetarian diet to see its effect on metabolic syndrome. No negative effects have been seen for this dietary treatment, aside from allergic reactions to specific elements of the diet among sensitive participants. Some participants in the research will not be given the portfolio diet that we are testing. Instead, they will be given the total vegetarian diet offered at Fredheim Health Center. Procedures and Protocol Metabolic syndrome is a cluster of risk factors for heart disease and diabetes. These include: increased waist circumference, elevated triglyceride levels, reduced HDL cholesterol, elevated blood pressure, elevated blood sugar levels. In order to test the different components of metabolic syndrome, we take measurements and tests on Monday morning, after your arrival and on Friday morning, the day of your departure (the last day of your stay at Fredheim). We will take the following measurements on you in the following ways:
1. Weight – measured in light clothing, without shoes 2. Height – measured without shoes 3. Waist circumference – measuring the midpoint between your lowest rib and your hip
bone 4. Blood pressure – taken after 5 minutes of rest. Three measurements will be taken 2
minutes apart and the first measurement will be disregarded and the last two measurements will be averaged.
We will also take blood from your arm using a syringe and needle. Each time (twice) we will take a small amount of blood. At the end of the research, any left over blood sample will be destroyed. The following blood tests will be taken:
1. Triglycerides 2. HDL cholesterol 3. LDL cholesterol 4. Blood glucose 5. HbA1c – shows the average blood sugar level over the previous three months.
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B. Description of the Process During this research study, you and the other women participating will be randomly divided into two groups. One group will continue eating the regular diet that Fredheim Health Center offers to all it guests without nuts. The other group will be eating the regular diet at Freheim with four elements added to the diet. These are specifically: Plant sterols such as a plant sterol ester–enriched margarine, Soy protein such as soymilk, tofu, and soy meat analogues, Viscous fibers such as oats, barley, and psyllium, and Nuts (including tree nuts and peanuts). All other features of the Fredheim Health Center will be the same for both groups of participants. Duration This research will take place while you are at Fredheim Health Center, during the 12 days of the health session. Side Effects There are no known side effects for eating the portfolio diet. Risks There are no anticipated risks for participation in this research project, aside from the risk of unknown food allergies. In the event of a participant manifesting a food allergy, appropriate medical attention will be provided. Benefits If you participate in this research, you will have the following benefits: free blood tests at the beginning of your stay at Fredheim and at the completion of your stay there, 12 days later. Confidentiality The information that we collect from this research project will be kept confidential. Information about you that will be collected during the research will be put away and no one but the researchers will be able to see it. Any information about you will have a number on it instead of your name. Only the researchers will know what your number is and we will lock that information securely stored with password protection. It will not be shared with or given to anyone except those in the research team and those helping with analyzing the study material. Sharing the Results The knowledge that we get from doing this research will be shared with you through the Fredheim newsletter before it is made widely available to the public. Confidential information will not be shared. After sharing this information in the Fredheim newsletter, we will publish the results in order that other interested people may learn from our research.
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Right to Refuse or Withdraw Example: You do not have to take part in this research if you do not wish to do so. You may also stop participating in the research at any time you choose. It is your choice and all of your rights will still be respected. Alternatives to Participating If you do not wish to take part in the research, you will be provided with the established standard treatment available at the Fredheim health center. Who to Contact If you have any questions you may ask them now or later, even after the study has started. If you wish to ask questions later, you may contact any of the staff at Fredheim Health Center or the primary researcher via telephone or email. Theresa Nybo Jakobsen Telephone # This proposal has been reviewed and approved by the local ethics committee (IRB), which is a committee whose task it is to make sure that research participants are protected from harm. If you wish to find about more about the IRB, contact [name, address, telephone number.]).
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PART II: Certificate of Consent I have read the foregoing information, or it has been read to me. I have had the opportunity to ask questions about it and any questions that I have asked have been answered to my satisfaction. I consent voluntarily to participate as a participant in this research. Print Name of Participant__________________
Signature of Participant ___________________
Date ___________________________ Day/month/year
Statement by the researcher/person taking consent I confirm that the participant was given an opportunity to ask questions about the study, and all the questions asked by the participant have been answered correctly and to the best of my ability. I confirm that the individual has not been coerced into giving consent, and the consent has been given freely and voluntarily. A copy of this informed consent form has been provided to the participant.
Print Name of Researcher / person taking the consent________________________
Signature of Researcher / person taking the consent__________________________
Date ___________________________ Day/month/year
19
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Fruchart, J.C., James, W. P. T., Loria, C. M., Smith Jr, S. C. (2009) Harmonizing the Metabolic Syndrome: A Joint Interim Statement of the International Diabetes Federation Task Force on Epidemiology and Prevention; National Heart, Lung, and Blood Institute; American Heart Association; World Heart Federation; International Atherosclerosis Society; and International Association for the Study of Obesity. Circulation. 120: 1640-‐1645. doi: 10.1161/CIRCULATIONAHA.109.192644
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Berkow, S. E. & Barnard, N. (2006) Vegetarian diets and weight status. Nutrition Review. 64(4):
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metabolic syndrome. International Diabetes Federation. Retrieved from http://www.idf.org/webdata/docs/MetS_def_update2006.pdf
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Federation. Retrieved from http://www.idf.org/sites/default/files/EN_6E_Atlas_Full_0.pdf
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Syndrome. International Diabetes Federation. Retrieved from http://www.idf.org/metabolic-‐syndrome
Jenkins, D. J. A., Kendall, C. W. C., Marchie, A., Faulkner, D. A., Wong, J. M. W., de Sousa, R.,
Emam, A., Parker, T. L., Vidgen, E., Lapsley, K. G., Trautwein, E. A., Josse, R. G., Leiter, L. A., and Connelly, P. W. (2003) Effects of a Dietary Portfolio of Cholesterol-‐Lowering Foods vs. Lovastatin on Serum Lipids and C-‐Reactive Protein. Journal of the American Medical Association. 290(4) 502-‐510. doi:10.1001/jama.290.4.502
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,
How to Create an Informed Consent Form The informed Consent Form must be a separate document from other documents. Except as provided in
sections 4, 5 and 6 below, informed consent shall be documented by the use of a written consent form
approved by the IRB and signed by the subject or the subjects' legally authorized representative. A copy
shall be given to the person signing the form. The full informed consent form must include:
Content of the written consent form
1. Statement that the activity involves research and a description of where the research activity will
occur.
2. An explanation of the scope, aims, and purposes of the research, and the procedures to be followed
(including identification of any treatments or procedures which are experimental) and the nature of
the expected duration of the subjects' participation.
3. Description of any reasonably foreseeable benefits, if any, to the subjects or others that may result
from the research.
4. A disclosure of appropriate alternative procedures or course of treatment (in instances where
therapeutic procedures are involved), if any that might be advantageous to the subjects.
5. A statement describing the extent to which confidentiality or records identifying the subjects will be
maintained except in unusual cases.
6. An offer to answer any questions the subjects may have about the research, the subject's rights or
related matters, and the name of the person (together with address and telephone number) to
whom the subjects may direct questions or must report an injury.
7. A Statement that participation is voluntary, that refusal to participate involves no penalty or loss of
benefit to which the subjects are otherwise entitled, and that the subjects may discontinue
participation at any time without penalty or loss to which the subjects are otherwise entitled if they
had completed their participation in the research.
8. For research which may involve more than minimal risk of injury the subject should be informed of
the following statement which must appear in the consent form: (to be modified for off-campus
research). "In the unlikely event of injury resulting from this research, Andrews University
is not able to offer financial compensation nor to absorb the costs of medical treatment.
However, assistance will be provided to research subjects in obtaining emergency
treatment and professional services that are available to the community generally at
nearby facilities. My signature below acknowledges my consent to voluntarily participate
in this research project. Such participation does not release the investigator(s),
sponsor(s) or granting agency (ies) from their professional and ethical responsibility to
me."
9. A space for the dated signatures of the subject, the principal investigator, and a witness. In the case
of a minor (the child must also sign if seven years of age or older) or a person unable to sign, a
second authorizing signature is required from the parent, guardian, or other responsible person. The
relationship must be specified.
In addition there is need to pay special attention to the following two definitions in your Informed
Consent, since lack of coercion and confidentiality are required for approval:
a) Coercion
Coercion means to compel or force someone to participate in or perform an action that would not
ordinarily be done of the individual's own free choice. Coercion may be present when recruiting
subjects for research. Participation should be free and voluntary, with no overriding statements. The
following are ways that coercion can be introduced: The researcher is the supervisor or pastor of the
participants. Telling subjects or their parents (when children are involved) how much they will be
helping the investigator by participating in research can be interpreted as coercive. Mentioning a
relationship that exists between the researcher and the potential subjects may be coercive. Subjects
may feel obligated to participate because they know or have seen the researcher at various times.
In cases of infants and children, mentioning that the researcher cares for or has cared for the child
puts parents in a very awkward and unfair position. Face-to-face recruitment has the potential to be
coercive. It is difficult for individuals to say no to someone who is directly in front of them and
talking about his or her research. Inflection, tone of voice, and nonverbal cues can inadvertently slip
into the recruitment process without the researcher's awareness. Coercion can be reduced if an
impartial third party presents the request for participation. Subjects should be protected from
coercion. If subjects are not protected, the IRB application must include an explanation of why
coercion is necessary as well as any possible repercussions of the coercion. The methods to be used
for coercing subjects must be detailed in the research proposal. A plan for informing subjects at the
end of the research of how and why they were coerced must be fully explained (see Debriefing).
Potential physical and/or psychological risks that may be incurred by subjects due to the coercion
must be identified, and procedures for addressing the risks must be established as part of the
debriefing procedures.
b) Confidentiality
Confidentiality refers to protection of subjects' privacy so that information collected about them, as
part of the research process, is not disclosed. Information may be revealed in group form, or as
individual examples, but not in a way that an individual may be identified. If the investigator collects
information on subjects over a period of time, such as in test-retest reliability or in
Pretest-posttest study designs, there must be a mechanism to relate various data to the same
subject. This may be done by using codes or identifiers (e.g., subject ID numbers) on both sets of
data that only the researcher can trace to a master name-number list. Because names and numbers
can be related, this list must be kept confidential by storing it in a private and secure location, such
as a locked file cabinet. If data are recorded in cases where the researcher personally knows
subjects, it must be acknowledged that the researcher knows the subjects personally, and the data
must be treated confidentially, because anonymity is not possible. The data must be collected in
such a way that the identity is not recorded. All data should be stored in a way that the person is
not identified when the identity is not crucial for the research objectives. In other words, the IRB will
require that data be collected in the least intrusive and most confidential way to serve the purpose
of the research. In a focus group situation, it must be acknowledged that there is a lack of
confidentiality due to the group situation. The consequences of this lack of confidentiality must be
outlined. It is important to acknowledge
It is important to acknowledge that subjects may waive the right of confidentiality. This may occur,
for example, when a subject specifically requests to be quoted. In the United States, all confidential
data must be stored by the researcher for 3 years. In Canada, data must be stored for 6 years.
Consider also that ethical research requires that the researcher is qualified to do the research they
are proposing.
Format of the Written Consent Form
1. The consent form should clearly identify the relationship of the researcher to Andrews University.
The name of Andrews University should appear centered at the top of the consent form together
with the name of the department with which the researcher is affiliated. In cases where an
anonymously returned questionnaire substitutes as a form of implied consent, the cover letter
accompanying the questionnaire should clearly identify how the research is connected with Andrews
University and one of its academic departments.
2. The consent from should clearly indicate the name, address, and phone number of the investigator
and an advisor or impartial third party whom the research subject may contact for additional
information if desired.
3. Places for the dated signatures of the subject (and/or parent/guardian, if applicable), investigator,
and witness should be included at the bottom of the consent form.
Retention of the Signed Informed Consent Form
1. A copy of the Informed Consent Form should be returned to the subject or the person legally
appointed to sign the Informed Consent Form to retain for his/her review.
2. The responsibility for retaining signed copies of the Informed Consent Form lies with the principal
investigator(s). These Informed Consent Forms should be kept in a secure depository along with the
researcher's other records for a reasonable amount of time (not normally to exceed three years).
Use of Alternate and/or Simplified Consent Forms
Certain situations may justify the use of alternate and/or simplified consent forms. However, in all cases the
investigator must demonstrate how the anonymity or confidentiality of the subject and his/her voluntary
participation in the project will be assured and maintained.
1. Oral Instructions Read to a Group. In the case of no risk or minimal risk research where
instructions are read to a group of subjects (e.g. a questionnaire passed out in a classroom setting,
with prior written authorization of the instructor), a short form to document the oral instructions
presented to the subjects may be used. A witness who heard the oral instructions read to the group
must co-sign the short form along with the researcher. A written copy of the oral instructions that
are to be read to the group must be submitted with the protocol. The items listed in Section 1 above
should be included in the oral instructions.
Research using surveys or questionnaires and dealing with sensitive areas of the respondent's own
behavior (illegal conduct, drug/alcohol use, sexual behavior, etc. See Appendix A, Exempt Review,
item 4) require special consideration. Although the purpose and use of surveys or questionnaires in
such research may be explained in a classroom setting (with prior documented permission of the
instructor(s) involved), requesting respondents to actually complete survey instruments in the
classroom setting is not recommended. Alternative methods of collecting forms completed at the
discretion of the respondent and which thus insure the respondent's anonymity should be employed.
2. Anonymous Surveys or Questionnaires. In the case of risk or minimal risk research involving
the use of surveys or questionnaires which are distributed individually and returned anonymously,
the cover letter explaining the purposes and procedures of the research project may substitute for
the consent form. Such a cover letter must be submitted with the protocol and should contain
reference to the items mentioned in section 1 above. It should state in the cover letter as well as on
the survey form itself that the return of the survey or questionnaire serves as a form of implied
consent.
3. Simplified Oral Interviews. Investigators conducting simple oral interviews, the content of which
qualifies as exempt from review, may submit an alternate form of written documentation in place of
an informed consent form. Such documentation should describe how the interviewer will explain
his/her research to the interviewee and how the researcher is prepared to insure the interviewee's
confidentiality and his/her right to refuse participation in the interview.
In all cases, the researcher is responsible for the filing of all proof of compliance with the above
procedures and to keep them for a period of three years
Waiving of Signed Consent Documentation
The IRB may waive the requirement for the investigator to obtain a signed consent form for some or all
subjects if it finds that either of the following conditions exists:
1. The only record linking the subject and the research would be the consent document and the
principal risk would be potential harm resulting from a breach of confidentiality. Each subject will be
asked whether he/she wants documentation linking the subject with the research, and the subject's
wishes will govern.
2. The research presents no more than minimal risk of harm to subjects and involves no procedures for
which written consent is normally required outside of the research context.
Waiving the Consent Process
The IRB may under certain special circumstances approve a consent procedure which does not include or
which alters some or all of the elements motioned above or may waive the requirement to obtain consent
provided the Board verifies and documents each of the following items:
1. The research involves no more than minimal risk to the subjects
2. The waiver or alteration of consent will not adversely affect the rights and welfare of the subjects.
3. The research could not practicably be carried out without the waiver or alteration.
4. Whenever appropriate, the subjects will be provided with additional pertinent information after
participation.
Consent form from Attending Physician and/or Other Health Care Professionals
In situations where an individual is currently being treated/evaluated by a physician and/or other health
care professional for a condition related to the objective of the research study, the researcher is required to
obtain the consent of the physician and/or health care professional prior to involving such research subjects
in the study.
Or faxed to attention IRB: (269) 471-6543
E-mail Letters: Letters may be sent as scanned email attachments to [email protected].
