Posted: April 25th, 2025

Biology Qualitative protocol draft assignment

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.

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

LITERATURE
REVIEW
4

MATERIALS
AND
METHODS

EXPERIMENTAL
UNITS
6

INCLUSION
CRITERIA
6

EXCLUSION
CRITERIA
6

SAMPLING
METHOD
6

SAMPLE
SIZE

RESEARCH
DESIGN
7

TYPE
OF
RESEARCH
DESIGN
7

DIET
7

EXERCISE
7

VARIABLES
7

INSTRUMENTS
AND
DATA
COLLECTION
SYSTEMS

STATISTICAL
ANALYSIS
8

RISKS
8

BENEFITS
8

CONFIDENTIALITY
8

TIMELINE
8

BUDGET
8

ETHICS
REVIEW

INCENTIVES
9

CONCLUSION
9

TABLES

TABLE
1:
INDEPENDENT
VARIABLES
10

TABLE
2:
DEPENDENT
VARIABLES
10

TABLE
3:
CONFOUNDING
VARIABLES

TABLE
4:
TIMELINE
11

TABLE
5:
BUDGET

APPENDIX

APPENDIX
1:
INFORMED
CONSENT
FORM
13

REFERENCES

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).

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

References

Agriculture
Research
Service
(2010)
Report
of
the
Dietary
Guidelines
Advisory
Committee
on

the
dietary
guidelines
for
Americans,
2010:
to
Secretary
of
Agriculture
and
the
Secretary

of
Health
and
Human
Services.
Washington,
DC:
Agriculture
Research
Service,
US

Department
of
Agriculture,
US
Department
of
Health
and
Human
Services.

Alberti,
K.G.M.M.,
Eckel,
F.
H.,
Grundy,
S.
M.,
Zimmet,
P.
Z.,
Cleeman,
J.
I.,
Donato,
K.
A.,

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

Balliett,
M.,
&
Burke,
J.
R.
(2013)
Changes
in
anthropometric
measurements,
body
composition,

blood
pressure,
lipid
profile,
and
testosterone
in
patients
participating
in
a
low-‐energy

dietary
intervention.
Journal
of
Chiropractic
Medicine.
2013(12):
3-‐14.

http://dx.doi.org/10.1016/j.jcm.2012.11.003

Berkow,
S.
E.
&
Barnard,
N.
(2006)
Vegetarian
diets
and
weight
status.
Nutrition
Review.
64(4):

175-‐188.
DOI:
http//dx.doi.org/10.1111/j.1753-‐4887.2006.tb00200.x

Boudreau,
D.M.,
Malone,
D.
C.,
Raebel,
M.
A.,
Fishman,
P.
A.,
Nichols,
G.
A.,
Feldstein,
A.
C.,

Boscoe,
A.
N.,
Ben-‐Joseph,
R.
H.,
Magid,
D.
J.,

&
Okamoto,
L.
J.
(2009)
Health
Care

Utilization
and
Costs
by
Metabolic
Syndrome
Risk
Factors.
Metabolic
Syndrome
and

Related
Disorders.
7(4):
305-‐314.
doi:10.1089/met.2008.0070.

Clarys,
P.,
Deliens,
T.,
Huybrechts,
I.,
Deriemaeker,
P.,
Vanaelst,
B.,
De
Keyzer,
W.,
Hebbelinck,

M.,
Mullie,
P.
(2014)
Comparison
of
nutritional
quality
of
the
vegan,
vegetarian,
semi-‐
vegetarian,
pesco-‐vegetarian
and
omnivorous
diet.
Nutrients.
6(3):1318-‐32.
doi:

10.3390/nu6031318.

Chen,
A.
K.,
Roberts,
C.
K.,
Barnard,
R.
J.
(2006)
Effect
of
a
short-‐term
diet
and
exercise

intervention
on
metabolic
syndrome
in
overweight
children.
Metabolism
Clinical
and

Experimental.
55(2006):
871-‐878

Dobbs,
R.,
Sawers,
C.,
Thompson,
F.,
Manyika,
J.,
Woetzel,
J.,
Child,
P.,
McKenna,
S.,
Spatharou,

A.
(2014)
Overcoming
obesity:
An
initial
economic
analysis.
Discussion
paper.
McKinsey

Global
Institute.
www.mckinsey.com/mgi.
Retrieved
from

http://www.google.se/url?sa=t&rct=j&q=&esrc=s&source=web&cd=1&ved=0CCEQFjAA
&url=http%3A%2F%2Fwww.mckinsey.com%2F~%2Fmedia%2FMcKinsey%2Fdotcom%2F
Insights%2FEconomic%2520Studies%2FHow%2520the%2520world%2520could%2520be

tter%2520fight%2520obesity%2FMGI_Overcoming_obesity_Full_report.ashx&ei=6zFbV
bSNIMupsgHWnIDoCA&usg=AFQjCNFYTgns_qo7FLj0UR0BOTYvUJQYVw&bvm=bv.93564
037,d.bGg

Esselstyn
Jr,
C.
B.,
Gendy,
G.,
Doyle,
J.,
Golubic,
M.,
Roizen,
M.
F.
(2014)
A
Way
to
Reverse
CAD?

The
Journal
of
Family
Practice.
63(7):356-‐364,
364a,
364b

Fraser,
G.
E.
(2003)
Diet,
Life
Expectancy,
and
Chronic
Disease:
Studies
of
Seventh-‐day

Adventists
and
Other
Vegetarians.
Oxford,
United
Kingdom,
Oxford
University
Press

Gaziano,
T.
A.,
Bitton,
A.,
Anand,
S.,
Weinstein,
M.
C.,
&
International
Society
of

Hypertension.(2009)
The
global
cost
of
nonoptimal
blood
pressure.
Journal
of

Hypertension.
27(7):1472-‐7.
doi:
10.1097/HJH.0b013e32832a9ba3.

Grundy,
S.
M.,
Brewer
Jr.,
H.
B.,
Cleeman,
J.
I.,
Smith
Jr.,
S.
C.,
&
Lenfant,
C.
(2004)
Definition
of

Metabolic
Syndrome:
Report
of
the
National
Heart,
Lung,
and
Blood
Institute/American

Heart
Association
Conference
on
Scientific
Issues
Related
to
Definition.
Circulation.
109:

433-‐438.
doi:
10.1161/01.CIR.0000111245.75752.C6

Hildrum,
B.,
Mykletun,
A.,
Hole,
T.,
Midthjell,
K.,
&
Dahl
A.
A.
(2007)
Age-‐specific
prevalence
of

the
metabolic
syndrome
defined
by
the
International
Diabetes
Federation
and
the

National
Cholesterol
Education
Program:
the
Norwegian
HUNT
2
study.
BMC
Public

Health.
7:220.
doi:10.1186/1471-‐2458-‐7-‐220

International
Diabetes
Federation
[IDF]
(2006)
The
IDF
consensus
worldwide
definition
of
the

metabolic
syndrome.
International
Diabetes
Federation.
Retrieved
from

http://www.idf.org/webdata/docs/MetS_def_update2006

International
Diabetes
Federation
[IDF]
(2013)
IDF
Diabetes
Atlas.
International
Diabetes

Federation.
Retrieved
from

http://www.idf.org/sites/default/files/EN_6E_Atlas_Full_0

International
Diabetes
Federation
[IDF]
(2014)
IDF
Worldwide
Definition
of
the
Metabolic

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

Jenkins,
D.
J.
A.,
Jones,
P.
J.
H.,
Lamarche,
B.,
Kendall,
C.
W.
C.,
Faulkner,
D.,
Cermakova,
L.,

Gigleux,
I.,
Ramprasath,
V.,
de
Souza,
R.,
Ireland,
C.,
Patel,
D.,
Srichaikul,
K.,
Abdulnour,

S.,
Bashyam,
B.,
Collier,
C.,
Hoshizaki,
S.,
Josse,
R.,
Leiter,
L.
A.,
Connelly,
P.
W.,
&

Frohlich,
J.
(2011)
Effect
of
a
Dietary
Portfolio
of
Cholesterol-‐Lowering
Foods
Given
at
2

Levels
of
Intensity
of
Dietary
Advice
on
Serum
Lipids
in
Hyperlipidemia:
A
Randomized

Controlled
Trial.
Journal
of
the
American
Medical
Association.
306(8)
831-‐839.

doi:10.1001/jama.2011.1202

Kahleova,
H.,
Matoulek,
M.,
Malinska,
H.,
Oliyarnik,
O.,
Kazdova,
L.,
Neskudla,
T.,
Skoch,
A.,

Hajek,
M.,
Hill,
M.,
Kahle,
M.,
&
Pelikanova,
T.
(2011)
Vegetarian
diet
improves
insulin

resistance
and
oxidative
stress
markers
more
than
conventional
diet
in
subjects
with

Type
2
diabetes.
Diabetic
Medicine.
28(5):549-‐59.
DOI:
10.1111/j.1464-‐
5491.2010.03209.x

Kaur,
J.
(2014)
A
Comprehensive
Review
on
Metabolic
Syndrome.
Hindawi
Publishing

Corporation:
Cardiology
Research
and
Practice.
Volume
2014,
Article
ID
943162,
21

pages
http://dx.doi.org/10.1155/2014/943162

Kent,
L.,
Morton,
D.,
Rankin,
P.,
Ward,
E.,
Grant,
R.,
Gobble,
J.,
Diehl,
H.
(2013)
The
effect
of
a

low-‐fat,
plant-‐based
lifestyle
intervention
(CHIP)
on
serum
HDL
levels
and
the

implications
for
the
metabolic
syndrome
status
-‐
a
cohort
study.
Nutrition
&

Metabolism.
10(58)

Lea,
E.
J.,
Crawford,
D.
&
Worsley,
A.
(2006)
Public
views
of
the
benefits
and
barriers
to
the

consumption
of
a
plant-‐based
diet.
European
Journal
of
Clinical
Nutrition.
(2006)60:
828-‐
837.
Doi:10.1038/sj.ejcn.1602387

Macknin,
M.,
Kong,
T.,
Weier,
A.,
Worley,
S.,
Tang,
A.
S.,
Alkhouri,
N.,
Golubic,
M.
(2015)
Plant-‐

Based,
No-‐Added-‐Fat
or
American
Heart
Association
Diets:
Impact
on
Cardiovascular

Risk
in
Obese
Children
with
Hypercholesterolemia
and
Their
Parents.
The
Journal
of

Pediatrics.
2015(166):
953-‐9
DOI:
http://dx.doi.org/10.1016/j.jpeds.2014.12.058

Mayneris-‐Perxachs,
J.,
Sala-‐Vila,
A.,
Chisaguano,
M.,
Castellote,
A.
I.,
Estruch,
R.,
Covas,
M.
I.,

Fitó,
M.,
Salas-‐Salvadó,
J.,
Martínez-‐González,
M.
A.,
Lamuela-‐Raventós,
R.,
Ros,
E.,

López-‐Sabater,
M.
C.
(2013)
Effects
of
1-‐Year
Intervention
with
a
Mediterranean
Diet
on

Plasma
Fatty
Acid
Composition
and
Metabolic
Syndrome
in
a
Population
at
High

Cardiovascular
Risk.
PLoS
ONE.
9(3):
e85202.
DOI:
10.1371/journal.pone.0085202

Neacsu,
M.,
Fyfe,
C.,
Horgan,
G.
&
Johnstone,
A.M.
(2014)
Appetite
control
and
biomarkers
of

satiety
with
vegetarian
(soy)
and
meat-‐based
high-‐protein
diets
for
weight
loss
in
obese

men:
a
randomized
crossover
trial.
American
Journal
of
Clinical
Nutrition.
100(2):548-‐58.

doi:
10.3945/ajcn.113.077503.

Nichols,
G.
A.,
&
Moler,
E.
J.
(2011)
Metabolic
Syndrome
Components
Are
Associated
with

Future
Medical
Costs
Independent
of
Cardiovascular
Hospitalization
and
Incident

Diabetes.
Metabolic
Syndrome
Related
Disorders.
9(2):
127–133.
doi:

10.1089/met.2010.0105

NIH
(2011)
How
is
Metabolic
Syndrome
Treated?
National
Heart,
Lung,
Blood
Institute,
National

Institutes
of
Health.
Retrieved
from
https://www.nhlbi.nih.gov/health/health-‐
topics/topics/ms/treatment

Ornish,
D,
Scherwitz,
L.
W.,
Billings,
J.
H.,
Brown,
S.
E.,
Gould,
K.
L.,
Merritt,
T.
A.,
Sparler,
S.,

Armstrong,
W.
T.,
Ports,
T.
A.,
Kirkeeide,
R.
L.,
Hogeboom,
C.,
Brand,
R.
J.
(1998)

Intensive
Lifestyle
Changes
for
Reversal
of
Coronary
Heart
Disease.
The
Journal
of

American
Medicine.
280(23):2001-‐2007.
doi:10.1001/jama.280.23.2001

Razavi,
M.,
Fournier,
S.,
Shepard,
D.
S.,
Ritter,
G.,
Strickler,
G.
K.,
Stason,
W.
B.
(2014)
Effects
of

Lifestyle
Modification
Programs
on
Cardiac
Risk
Factors.
PLoS
ONE.
9(12):
e114772.

doi:10.1371/journal.pone.0114772

Riccardi,
G.,
Giacco,
R.
&
Rivellese,
A.
A.
(2004)
Dietary
fat,
insulin
sensitivity
and
the
metabolic

syndrome.
Clinical
Nutrition.
54:447-‐456.

Rosell,
M.,
Appleby,
P.,
Spencer,
E.
&
Key,
T.
(2006)
Weight
gain
over
5
years
in
21,966
meat-‐

eating,
fish-‐eating,
vegetarian
and
vegan
men
and
women
in
EPOC-‐Oxford.
International

Journal
of
Obesity.
30(9):1389-‐1396.
DOI:http://dx.doi.org/10.1038/sj.ijo.0803305

Sabaté,
J.
&
Wien,
M.
(2010)
Vegetarian
diets
and
childhood
obesity
prevention.
American

Journal
of
Clinical
Nutrition.
91(5):1525S-‐1529S.
DOI:

http//dx.doi.org/10.3945/ajcn.2010.28701F

Sullivan,
S.,
Klein,
S.
(2006)
Effect
of
Short-‐Term
Pritikin
Diet
Therapy
on
the
Metabolic

Syndrome.
The
Journal
of
Cardiometabolic
Syndrome.
Fall
2006:
308-‐312

Trimble,
M.
(2014)
Economic
Burden
of
Prediabetes
Up
74
Percent
Over
Five
Years.
American

Diabetes
Association.
Retrieved
from
http://www.diabetes.org/newsroom/press-‐
releases/2014/economic-‐burden-‐of-‐prediabetes-‐up-‐74-‐percent-‐over-‐five-‐years.html

Turner-‐McGrievy,
G.
&
Harris,
M.
(2014)
Key
elements
of
Plant-‐Based
Diets
Associated
with

Reduced
Risk
of
Metabolic
Syndrome.
Current
Diabetes
Report.
14:524.
DOI

10.1007/s11892-‐014-‐0524-‐y

Tuso,
P.
J.,
Ismail,
M.
H.,
Ha,
B.
P.
&
Bartolotto,
C.
(2013)
Nutritional
Update
for
Physicians:

Plant-‐Based
Diets.
The
Permanente
Journal.
17(2):
61-‐66.

http://dx.doi.org/10.7812/TPP/12-‐085

Vessby,
B.
(2003)
Dietary
fat,
fatty
acid
composition
in
plasma
and
the
metabolic
syndrome.

Current
Opinion
in
Lipidology.
14:15-‐19

WHO
(2015)
Informed
Consent
Form
Templates.
World
Health
Organization.
Retrieved
from

http://www.who.int/rpc/research_ethics/informed_consent/en/

Zivkovic,
A.
M.,
German,
J.
B.,
&
Sanyal,
A.
J.
(2007)
Comparative
review
of
diets
for
the

metabolic
syndrome:
implications
for
nonalcoholic
fatty
liver
disease.
The
American

Journal
of
Clinical
Nutrition.
86(2)
285-‐300

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 irb@andrews.edu.

mailto:irb@andrews.edu

Expert paper writers are just a few clicks away

Place an order in 3 easy steps. Takes less than 5 mins.

Calculate the price of your order

Type of paper needed:

Pages:

You will get a personal manager and a discount.

Academic level:

We'll send you the first draft for approval by at

Total price:

$0.00