Increased Adherence to Physical Activity on Prescription (PAP) Through Mindfulness- A Pilot Study.
Phase: NA
Conditions: Physical Activity, Life Style, Mindfulness
Sponsor: Region Skane

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Increased Adherence to Physical Activity on Prescription (FAR) through mindfulness - a randomized
study in primary care (FAR-MIND)
Doctoral student
Peter Nymberg Doctoral 
StudentCentre for Primary Care 
Research (CPF)CRC, Input72, 
SUS205 02 MalmöTel: 
+46705759810E-mail; 
Peter.Nymberg@med.lu.se
Principal investigator
Bengt Zöller Associate 
ProfessorCentre for Primary Care 
Research (CPF)CRC, Input72, 
SUS205 02 MalmöTel: +4640 
391954Fax:+4640391370E-mail; 
Bengt.zoller@med.lu.se
Co-supervisors:
Kristina Sundquist ProfessorCentre 
for Primary Care Research 
(CPF)CRC, Entrance 72, SUS20502 
MalmöE-mail; 
Kristina.sundquist@med.lu.se
Co-supervisors
Eva Ekvall-Hansson, Associate 
ProfessorDepartment of Health 
SciencesHCS Baravägen 3221 00 
LundE-mail; Eva.ekvall-
hansson@med.lu.se
Co-supervisors
Emelie Stenman PhDCentrum for 
Primary Care Research (CPF)CRC, 
Entrance 72, SUS20502 MalmöE-
mail; Emelie.stenman@med.lu.se
Co-supervisors
Susanna Calling Associate 
ProfessorCentre for Primary Care 
Research (CPF)CRC, Entrance 72, 
SUS20502 MalmöE-mail; 
Susanna.calling@med.lu.se
Co-supervisors
Jan Sundquist ProfessorCentre for 
Primary Care Research (CPF)CRC, 
Entrance 72, SUS20502 MalmöE-
mail; Jan.sundquist@med.lu.se
Faculty of Medicine

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Introduction
Patients who are physically inactive according to WHO recommendations, will be 
randomized to intervention with mindfulness, mindfulness and physical activity on 
prescription (FAR)® or FAR® only. The randomization will take place in conjunction 
with receiving a prescription for physical activity to evaluate the effect of mindfulness. 
The intervention will be followed up with questionnaires, accelerometers and analysis 
of biomarkers. The study will be preceded by a smaller pilot study with 90 patients to 
test the adaptability and the magnitude of the effects that can be expected.
Background
whereas cardiovascular disease is one of the leading causes of death in the industrialised 
world(1); Some causes of cardiovascular diseases are modifiable, such as lifestyle habits, 
while others are congenital. There is currently extensive evidence showing a link between 
unhealthy lifestyles and the onset of cardiovascular diseases (2). The risk factors and health 
factors are the same all over the world: exercise, diet, smoking, waist circumference, blood 
lipids, alcohol intake, diabetes, prediabetes and psychosocial health, and stress (2). 
Sweden's reduced mortality from cardiovascular disease can largely be explained by better 
clinical care in special departments for acute cardiac care with new treatment methods, but 
also increased primary prevention, which has been shown to have greater effects on survival 
than secondary preventive measures do (3). General screening of the entire population is a 
way of trying to identify individuals at risk before they fall ill or develop symptoms and seek 
treatment for them. For example, in general screening, it has been seen that a survey of 
lifestyle habits can predict the risk of developing cardiovascular diseases (4). Another way to 
go is opportunistic screening, i.e. to take the opportunity for screening, in connection with 
the individual contacting the health care system regardless of the reason for the visit. 
Opportunistic screening has proven to be an effective way to find high-risk individuals before 
they develop diabetes, among other things (5, 6), alcohol-related diseases (7) and elevated 
cholesterol levels (8). This screening method of individuals in contact with the healthcare 
system is presumed to be a better alternative than performing a general screening in the 
population to find individuals with an elevated risk of cardiovascular disease (9-13).
HeredityBiologically speaking, 50% of genetics are passed on from parent to child. 
The incidence both in terms of cardiovascular disease such as deep vein 
thrombosis, pulmonary embolism, aortic aneurysm, stroke

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and myocardial infarction is linked both to parents and to siblings' illness (14-17) The 
genetic predisposition to disease can in turn be influenced by factors in the environment 
such as environment and lifestyles. This means that for those with a heredity, there is 
an additional increased risk associated with external harmful factors (18).
Prevention
A large number of intervention studies have studied how lifestyle changes affect the 
incidence of chronic diseases; For example, increased physical activity has been shown to 
lower the risk of diabetes, high blood pressure and obesity (19-26). A structured 
motivational health conversation shows both an immediate effect with changed lifestyle 
habits and a long-term effect with reduced self-reported illness in both diabetes and 
cardiovascular disease (27-29). It has also been shown that interventions focusing on both 
diet and exercise have a better effect through regular follow-up (25). In order to facilitate 
discussion regarding changes in health behaviour and to be able to do so successfully, 
training in conversation methodology is required for those who carry it out (30, 31).
Physical activityA Swedish study has shown that a large part of the waking hours of 50-
64 year olds are dominated by sedentary sitting (about 60%). Only seven per cent of 
this age group meet the recommendation for physical activity in terms of both intensity 
and duration (32). With a sedentary lifestyle, the risk of several chronic conditions such 
as obesity, diabetes, hypertension and thus also an increased risk of metabolic 
syndrome and cardiovascular diseases increases (33-36). It is primarily aerobic physical 
activity that is considered to counteract and suppress the metabolic syndrome (37). The 
international recommendation of the WHO (2011) (38) is at least 150 minutes of 
physical activity per week of moderate intensity, or at least 75 minutes of high intensity. 
Physical activity on prescription (FAR)® (39) can be recommended as both primary and 
secondary prevention aimed at various disease states. The recommendations per 
disease state are described in the handbook Physical activity in disease prevention and 
treatment (FYSS) (40). The recommendations include the amount of physical activity, 
but not where the boundaries are with a sedentary lifestyle, i.e. how much of the hours 
of the day can be spent sitting still without affecting health (41). One problem is lack of 
adherence to recommendations on physical activity (42-45) and difficulty in objectively 
monitoring treatment outcomes. In diabetes care, for example, the possibility of 
following up treatment results with HbA1c has led to a therapeutic revolution.

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A similar simple and inexpensive test to follow the effect of intervention with lifestyle habits 
such as physical activity would have been of great value to the patient and caregiver.
Self-rated healthSelf-rated health encompasses all the different dimensions of the 
individual, physical, mental as well as social (46). The individuals' self-perceived health 
is assessed by asking the question "How do you assess your general state of health in 
relation to peers?" with five response alternatives; Very good, good, somewhat, bad or 
very bad (47-49). Poor self-rated health is associated with unhealthy lifestyles (50). 
There are demonstrated epidemiological associations between self-rated health and 
early death from cardiovascular disease (51, 52). This association with morbidity and 
mortality is independent of known risk factors such as medical, social and demographic 
(52-57). However, it can be difficult to compare self-rated health between different 
countries as there are cultural differences (46, 58). There may also be variations 
between different age groups, but also over time (59). A correlation has been shown 
between poor self-rated health and various biomarkers such as increased levels of 
inflammatory markers such as CRP and increased white blood cell counts, but lower 
levels of haemoglobin, albumin and high-density lipoprotein (HDL) (60, 61). Associations 
between newer markers such as microRNAs (miRNAs) (see below) and self-rated health 
have not been studied. Heredity and correlation with self-rated health and lifestyle habits 
have also not been investigated before.
Stress and sleep
Subjective sleep problems have been shown in prospective studies to be associated with the 
onset of acute myocardial infarction after adjusting for a number of parameters. Above all, they 
were associated with sleep problems, early awakening and the feeling of not being sleepy (62). 
Both sleep problems and premature awakening are associated with some of the modifiable risk 
factors for cardiovascular disease, such as hypertension, obesity, diabetes and hyperlipidaemia 
(63-65). Studies have shown associations in those with sleep periods of 8 hours or more with 
low levels of physical activity. But also that those with less sleep than 6 h/day had an increased 
mortality rate (66). Sleep deprivation and sedentary behaviour also independently affect the 
mental health condition, where little sleep leads to increased stress and a higher degree of 
suicidal thoughts (67). Long-term stress causes sleep problems, but also an increased risk of 
cardiovascular disease (68). There is a connection between sleep deprivation, stress and 
endothelial function in the body's vessels, but it is unclear whether the increased risk of 
cardiovascular disease is due to the lack of sleep in the body.

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or if there is an impact on endothelial function based on other factors that result 
from sleep deprivation (69).
MindfulnessMindfulness can be described as an approach with conscious presence, 
which is about living in greater awareness of oneself here and now without valuing 
thoughts and feelings. This approach works to ensure that the individual perceives the 
world as it is without being influenced by previous experiences, preconceptions or 
feelings, which in turn possibly strengthens the ability to make decisions in an objective 
way (70). Some association between the risk of cardiovascular disease and the ability to 
be consciously present has been demonstrated, with individuals with good 
cardiovascular health having a better ability to be consciously present (71). Overweight 
individuals can be helped with mindfulness to change their behavior and their 
relationship with food. This is especially true for negative behaviors such as binge eating, 
comfort eating, and snacking between main meals (72-74). A difference has been shown 
between those who are able to maintain their physical activity and those who 
discontinue, especially in conscious presence, acceptance and depression. It is not clear 
whether the individuals who continue to be physically active over time are so thanks to 
their conscious presence or whether it is a result of the physical activity itself (75).
BiomarkersMicroRNAs (miRNAs) are small non-coding RNA molecules that regulate the expression of 
RNAs, and thereby the expression of proteins. MiRNA is relatively stable in both serum and plasma. 
Some diseases have been associated with an altered expression in miRNAs, which has led to the use of 
miRNA analysis in the diagnosis and prognosis of some diseases (76, 77). Telomeres are the ends of 
chromosomes and act as protection against the breakdown of DNA. With an increased number of cell 
divisions, the telomeres become shorter and eventually become so short that the cell perceives the ends 
of the chromosome as damaged DNA and begins to break down, which is expressed in physical aging in 
the individual. Immediately after physical activity, there has been an altered expression of mRNA and 
miRNA molecules that regulate the length of telomeres, including an increased presence of the enzyme 
telomerase that protects the telomeres (78). However, this is controversial as other studies have shown 
that increased physical activity does not result in any significant change. However, a correlation has been 
shown between reduced sedentary lifestyle and an increased catheteric length (79, 80). There are few 
studies with mindfulness that have focused on telomeres, but those that have been done show an 
increased activity of telomerase (81). If a reduced risk of

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cardiovascular disease through a change in lifestyle causes a concomitant change in 
the expression of miRNAs and telomere length has not been investigated so far (82).
The Health and Medical Services Act (1982:763) §5 states that disease 
prevention work is the responsibility of primary health care. This is further 
described in the guidelines in Region Skåne for the financial compensation 
system, which describe that primary health care should actively offer citizens 
health-promoting and disease prevention measures (83).
"The Provider is responsible for ensuring that its hired staff has knowledge of, and that 
there are procedures for, identifying, assessing, initiating and carrying out as well as 
following up correct measures regarding lifestyle habits, when relevant from the Patient's 
perspective and the current medical condition." (p. 27; Prerequisites for Accreditation 
and Agreement for Health Care Center in Health Choice Skåne for the year 2016)
The guidelines cover both primary prevention, i.e. health counselling for healthy and 
at-risk groups, and secondary prevention for those already diagnosed with a 
disease. The mission of primary care, which is to prevent illness and worsening of 
pre-existing disease, is important for each individual, but also from a socio-economic 
perspective. Secondary preventive work has been actively conducted for many 
years in primary care with diabetes clinics, hypertension clinics, asthma/COPD 
clinics and clinics for smoking cessation.
Despite the fact that there is a clear disease prevention mission and knowledge 
that physical activity counteracts the onset of so-called well-being diseases, the 
inactive time is generally increasing in the population.
Purpose
To investigate whether mindfulness can increase adherence to FAR® in inactive individuals.
More specifically, we intend to:
1. Study whether mindfulness can strengthen adherence to FAR®, i.e. 
increase the amount of physical activity and reduce physical inactivity.
2. Study the effect of intervention on measured vital signs, routine blood 
tests, self-rated health, sleep and lifestyle habits.

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3. Study the effect of intervention on biomarkers e.g. inflammation markers 
(cytokines), microRNA and telomeres as well as the relationship between 
biomarkers and physical activity/inactivity.
Hypothesis
The main hypothesis is that Mindfulness increases the compliance of inactive individuals and leads to a
increased physical activity and reduced inactivity.
Hypothesis 1: Self-perceived sleep problems decrease and self-perceived health increases after
mindfulness/FAR®-intervention.
Hypothesis 2 The intervention with FAR/® mindfulness affects biomarkers (e.g. cytokines,
miRNAs, telomeres) in individuals with low levels of physical activity.
Studies
The following describes the implementation of the research project in the health choice 
units involved. The project, which consists of an intervention, will run from September 
2016 until December 2018 at the latest. The project starts with a pilot study that ends 
after 6 months of follow-up. The health choice units involved will ask all individuals 
seeking care and are between 40-65 years old if they want to participate in the study
Inclusion/exclusion
Individuals between the ages of 40-65, regardless of why they visit any of the 
committed health choice units, will be asked to participate by asking if they are 
insufficiently physically active (<150 minutes per week at moderate intensity or <75 
minutes per week at high intensity).
Exclusion Criteria: Dementia, severe mental disorder, new-onset untreated untreated 
unstable anginapectoris, or myocardial infarction within 6 weeks prior to study entry. Those 
with physical disabilities that prevent physical activity and individuals who do not master 
the Swedish language in speech and writing will be excluded. Patients who have abnormal 
values according to guidelines that require same-day or weekly medical consultation.
Procedure Inclusion

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At the care units, everyone who visits will be asked about study participation. There 
will be posters with information at the entrances and in other suitable places. Those 
who wish to participate in the study agree to this by signing informed consent after 
receiving oral and written information. Information about the study will be provided 
by the district nurse/nurse involved in the study, who will then also collect the 
informed consent. The opportunity to ask questions about the study will be repeated 
at subsequent visits as well as an opportunity to discontinue their participation. The 
potential research subject should estimate their physical activity level in minutes per 
week for inclusion assessment. The research subjects are asked to come one 
morning for fasting blood sampling.
Measurement methods
Physical activity; Health-promoting physical activity is any physical activity that improves 
health and physical capacity without causing harm or posing a risk. The international 
recommendation of the WHO (2011) (38) is at least 150 minutes of physical activity per 
week at moderate intensity, or at least 75 minutes at high intensity. Intensity refers to 
how strenuous the activity is. Moderate intensity refers to housework, gardening, brisk 
walks or the like. High intensity refers to running, swimming, aerobics, or similar.
Accelerometer: The Actigraph GT3X is a digital motion meter that will be attached to the subject 
at waist height. The accelerometer records the time in motion as well as the time inactivity. 
Over a seven-day period, about 40,000 measurement points are collected per accelerometer.
FFMQ (Five Facets of Mindfulness); is an instrument that measures five aspects of 
mindfulness. It consists of 29 statements where it is assessed on a five-point scale how 
well the statement is true "Never/almost never", "Rarely", "Sometimes", "Often" or "Always". 
In the compilation, the answers are graded from one to five, grouped and analyzed based 
on the five aspects of mindfulness (84, 85). The aspects that are measured are the ability 
to: Observe, Not react (in the face of inner experiences), Describe, Not judge and Act 
consciously. ISI (Insomnia Severity Index); is a self-assessment questionnaire that 
measures insomnia in order to quickly obtain a measure of the severity of sleep disorders. 
The scale consists of 7 questions that evaluate falling asleep, sleep during the night, early 
waking up, the feeling of being rested, how the sleep problems affect daily life and how the 
sleep pattern worries the individual. For each question, the participants must take a position 
on how they have experienced their sleep habits over the past two

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weeks and grading the answers from 0 to 4, where 0 stands for "not at all" and 4 stands 
for "very". Scores between 0 to 7 indicate the absence of significant sleep problems. 
Scores from 8 to 14 show some sleep problems but not as a sleep disorder. Scores from 
15 to 21 indicatearcclinically significant moderate sleep disorder. Scores between 22 
and 28 indicate clinically significant severe sleep problems (86, 87). Self-rated health; 
Self-rated health encompasses all the different dimensions of the individual, physical, 
mental as well as social (46). The individuals' self-perceived health is estimated through 
a simple question- How do you think your general health is in relation to peers- with five-
answer alternatives; Very good, good, somewhat, bad or very bad (47-49).
Initial visit
At the visit, participants will provide blood samples, measurement of body 
constitution and vital parameters, and submit completed questionnaires for mapping 
the hereditary prevalence of cardiovascular disease and lifestyles, and will receive 
accelerometers to be worn for one week until the follow-up visit. The results from the 
sampling here constitute the study's baseline.
The visit includes:
1. Information about the study
2. Written informed consent
Questionnaires:1) 
Country of birth,2) 
Occupation4) 
Illness5) 
Medication
6) Family history/hereditary (siblings and parents). coronary artery disease, stroke, 
venous thrombosis, diabetes, hypertension7) Self-assessment of lifestyle habits 
according to the National Board of Health and Welfare's elaborated questions 
regarding lifestyle habits.8) Mindfulness assessment with FFMQ9) Self-
assessment sleep with ISI
Clinical examination:
1) Length

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2) Weight3) 
Blood pressure.
Sampling:
Plasma samples and whole blood are taken fasting for;
1) Cholesterol, triglycerides, HDL, LDL.2) fP-glucose3) Venous blood samples for 
later analysis of biomarkers such as proteins, DNA, RNA and
miRNAs in order to see if they can be used as prognostic biomarkers, but also 
to see any change after intervention. We will also analyze telomer lengths in 
blood using qPCR method to see the association between risk of disease but 
also change after intervention. Please note that those who have given consent 
have also given consent for us to analyze their samples even if they choose to 
drop out before the intervention.
Follow-up visits
The individuals who wish to participate and meet the inclusion criteria will be 
offered a health consultation with the district nurse for review of collected material, 
blood samples and questionnaires. All patients who have abnormal values 
according to established guidelines will follow the flow chart for usual treatment. At 
this visit, inclusion and exclusion criteria are checked and the patient is again 
informed and has the opportunity to ask questions about the study. Patients who 
join the study will be randomized to either mindfulness, mindfulness with FAR®, or 
FAR® alone. Everything is documented partly in patient records but also in patient 
forms (case report form; CRF) together with the serial number.
The visit includes:
3. Feedback on collected information
4. Position on inclusion/exclusion criteria
5. Any additional measurements and sampling
Randomization
The randomization takes place after the inclusion in the study but before the follow-up visit where the 
research subject will find out which group they belong to. After inclusion, a commercial email is sent with 
serial number, gender and age to the contact person (peter.nymberg@med.lu.se)

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which makes a computerized randomization based on chance. The patient or staff 
cannot choose which group they should belong to.
Serial number
After the patient has consented to join the study, they are assigned a serial number. 
This serial number replaces the patient's name and social security number and then 
follows the patient throughout the study. Personal data will be processed in 
accordance with the Personal Data Act (PUL1998:204). The identification lists will be 
sent to the CPF and stored there in a secure manner so that no one can 
independently access them and separate from the collected data for 20 years after 
the end of the study, after which they will be destroyed. Patients' individual data can 
be obtained directly from the healthcare professional participating in the study or 
from Associate Professor Bengt Zöller in charge of research. The results of the study 
will be published in international peer-reviewed scientific journals.
Intervention
Three different interventions will occur in the study, prescription for physical 
activity, mindfulness and a combination of both.
Prescription for Physical Activity (FAR)®
Prescription for physical activity (FAR)® is a method for motivating individuals to increase 
physical activity based on their own abilities and preferences. The prescription must be 
followed up after three months according to normal routines, for evaluation in this 
evaluation there is the possibility of a further prescription. FAR® should be prescribed 
after inclusion of the district nurse who meets the patient. When prescribing, patients 
should also be informed about the connection between sedentary lifestyle, activity and 
disease. If necessary, a physiotherapist will be consulted regarding the prescription of 
FAR,® this applies to those with musculoskeletal problems. Prescribing of FAR® will be 
performed further after 3 months with follow-up after an additional 3 months
Mindfulness
The mindfulness intervention consists of an 8-week course according to the Here & Now 
program (88), with a course occasion in groups (about 1.5 hours/time) each week, 20 minutes 
of individual daily meditation practice and short everyday exercises. The daily exercises require 
access to a computer/tablet or smartphone, where the participants log in with their serial 
number. Login

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will be recorded to link to the adherence at group level of the daily exercises. 
The courses will be given in group form with 10 participants per group.
FAR® Group
Patients in this group will receive a Physical Activity Prescription (FAR)® at 
baseline and after 3 months.
Mindfulness group
This group receives only an 8-week mindfulness course with one meeting per 
week and 20 minutes of daily exercises.
Mindfulness/FAR® group
The patients randomized to this group receive an 8-week mindfulness course with 
one meeting per week and 20 minutes of daily individual exercises. These patients 
receive FAR® at baseline and after 3 months.
Case Report Form (CRF)
For each patient, a CRF will be kept where all measurements as well as the 
hereditary etc. are documented. The CRF does not contain any personal data but will 
be marked with the patient's serial number and stored at the care unit during the study 
period and then collected for the CPF after completed intervention and follow-up.
Questionnaire management
The assessment forms used during the study at baseline but also during follow-up 
are pseudonymized and replaced with sequential numbers assigned to the patient. 
In the same way, the health questionnaires that are completed in connection with the 
sampling are handled. After that, the copied forms are sent to CPF, the copies are 
saved at the care units. On CPF, data will be entered via REDCAP and saved in a 
server that does not have an internet connection. Random sampling of input data will 
be performed to check the consistency of input questionnaires and laboratory value.
Centre for Primary Care Research
Ref: Peter NymbergCRC, building 28 floor 11 entrance 27
Jan Waldenströmsgata 35Malmö University Hospital 205 02 Malmö

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Interruption
In the full study, this is compensated for an expected non-response of 30%. If a person's 
participation is interrupted, he or she is counted as a non-member in the analysis and is 
not replaced by another person. People who are asked but do not want to be included in 
the study are not randomized and are therefore not counted as non-response.
Follow-up of intervention group and control group
All participants in the study will be evaluated with the same measurements and samples as 
at baseline, as well as control for unexpected effects. Patients will be asked at 3, 6 and 12 
months to submit new samples and answer the same questionnaire as at baseline. This 
will be done by letter, in case of no-show, the patient will be called to make an appointment 
for sampling. They will also be allowed to wear an accelerometer for 7 days on these 
occasions. Samples to be analyzed are marked with the same serial number as before and 
the measured values must be documented both on the CRF and in the patient record.
Samples for freezing
Participating health choice units perform venous sampling of the research samples 
according to the sampling kits sent out. This also means assisting in sending the 
marked test tubes to the laboratory for further handling and transport to the CPF. 
This refers to sampling before and after intervention and during follow-up. This 
means sampling at 0 months, 3 months, 6 months and at full study also at 12 
months, which means four occasions per participant.
Tests and procedures
In vitro kits, including referrals, instructions and labels for labelling, will be prepared at 
the CPF laboratory and packed in boxes, one per participant and sampling. These boxes 
will be distributed to the participating health choice units. The unused tubes should be 
returned to the CPF after the study is completed. A detailed annex to instructions will be 
prepared by the CPF. The samples to be submitted to the CPF are marked with the date 
and the participant's serial number. Blood volume is 36 ml per test batch, a total of 108 
ml after three rounds of tests and 144 ml after four rounds. It must be noted in the 
patient's medical record that samples have been taken as part of a research study.

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Study Flowchart
Outcome measures
Association between self-rated health, lifestyle habits, heredity for 
cardiovascular disease, physical activity level, vital parameters and blood tests.
All patients who come to the health choice units and are between 40 and 65 years old are asked about participation in the 
study, answer the question about physical activity. Informed
consent
Control Inclusion Criteria Questionnaire ,Time to Fasting
sampling
Mindfulness
Follow-up/health conversation with Nurse/District Nurse, feedback sampling, questionnaire, 
collection accelerometer, randomization. Checking information prescribing ofFAR.®
Mindfulness + FAR®
FAR®
Mindfulness course 8 weeks
SamplingReceiving accelerometer 1
week
Mindfulness course 8 weeks
After 3 months of sampling fasting,
questionnaires and measurements. New FAR
After 3 months-sampling 
fasting,questionnaires, measurements.
New FAR
After 3 months of sampling 
fasting,questionnaires, measurements
New FAR
6 months follow-up with sampling questionnaire and accelerometer-Pilot study end
Full study follow-up also at 12 months 
with samples
questionnaires, measurements
and accelerometer
Full study follow-up also at 12 months 
with samples,
questionnaires, measurements
and accelerometer
Full study follow-up also
at 12 months co-samples, questionnaires,
Measurements and accelerometer

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Change in physical inactivity and activity
Difference in inactivity between intervention group and control group as measured by accelerometer
Change in self-rated worry and anxiety according to PHQ 9 after intervention
Change in Conscious Presence According to FFMQ After Intervention
Change in sleep according to ISI after intervention
Differences in biomarker levels between the different intervention groups
Power calculation
We will carry out a pilot study in order to make a more accurate power calculation 
which will be based on the results of the pilot study (89). We plan to include 30 
people per group in the pilot study, a total of 90 people.
The sample size for a full-scale intervention study with follow-up is based on a 1:1 ratio 
between the groups and calculated to N=321 in the intervention group and N=321 in the 
control group per group based on a power analysis with 5% significance level and 80% 
power. The non-response rate is calculated at about 30%. The calculation is based on 
other studies with compliance to physical activity on prescription as an outcome 
measure, where 50% of the individuals followed the recommendation on physical 
activity based on FAR,® we expect an increase of 25% from 50% to 62.5% adherence
Data analysis
Group comparison analysis will be conducted using chi-2 test for categorical 
variables. Quantitative variables will be analyzed with ANOVA or Kruskal-Wallis pre-
normal-distributed and non-normally distributed variables, respectively. Correlations 
between different variables will be investigated using regression analyses (90).
Safety and ethical aspects
Participants in all groups are contacted by a doctor according to a flow chart if abnormal 
measurements appear or if physical symptoms occur during intervention that need to be 
assessed by a doctor. Conversations about lifestyle habits can raise thoughts and 
concerns about personal health, and if necessary, there will therefore be the opportunity 
to get feedback via the district nurse or your regular doctor. Personal identity number 
and name will be replaced with a serial number that follows the form and

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samples through the study, which means that all data during analysis is completely without 
personal data and only marked with serial number. The identification lists will be kept at the 
health choice units until the analyses are completed, after which the identification lists will 
be stored at the CPF in a secure manner so that no unauthorised person can access them. 
Presentation of results from the study will take place at group level, which means that it is 
not possible to identify individuals. The individuals included in the study are covered by the 
Patient Injury Act (1996:799) as they are patients at visits to the health choice unit and are 
covered in clinical research by the same protection as if they were only patients. The study 
has received ethical approval from the Regional Ethics Review Board in Lund (2016/404). 
The study is registered on clinicaltrials.gov(20160826) rainr NCT02869854.
Economics
The research subjects participating in the study do not receive any compensation for 
loss of income or travel. Visits to the district nurse are currently free of charge, in the 
event of the introduction of a possible fee for visits to the district nurse, this should not 
affect the patients included in the study. The visits that may be relevant with a cost 
are if there is a need for treatment of a doctor/counsellor/physiotherapist contact. The 
health choice units are compensated with SEK 1200 per patient for the intrusion into 
the activities, which includes sampling and collection of data for the study. This refers 
to sampling before and after intervention and at follow-up after 3, 6 and 12 months. In 
total, the pilot study involves about 90 patients, 30 people in each group.
CPF covers the cost of all test tubes and blood analyses included in the study. 
CPF is responsible for pre-printing forms, envelopes and return postage.
Expected benefits
Prevention of cardiovascular disease is of paramount importance as this is the most 
common cause of death in Sweden. Primary and secondary prevention of 
cardiovascular diseases means reduced suffering for patients and great socio-economic 
benefits (3). By reducing inactivity, the risk of developing the disease can be reduced. 
Measurement of self-rated health creates the conditions for patient-centred care by 
starting from the patient's experience. Patients perceive it as important to work with 
lifestyle habits in primary care (91) as health risks can be detected. Through lifestyle 
counselling in primary care, patients can receive guidance to a healthier life (91-93).

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For the health choice units, this can lead to a more structured work on lifestyle habits 
and increased coverage, which can have a positive impact on the health choice 
units' finances. For the staff concerned, this can lead to increased job satisfaction.
Timetable
The pilot study is scheduled to begin in September 2016 and is expected to last no later than 
December 2019, The number of individuals included in the pilot study amounts to 88 
individuals (180829). Full-scale study will be planned according to Power calculation based 
on pilot study. Analysis of collected blood samples in the biobank will be analyzed during the 
spring from February 2019 to December 2019 including statistical analysis and report writing.

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