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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

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.

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

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

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.

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.

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.

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.

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.

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

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

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

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

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.

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.

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.

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.]).

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

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