Longitudinal Approach to Generate Positive Cardiometabolic Health Outcomes in Severe Mental Illness
Phase: NA
Conditions: Psychotic Disorders
Sponsor: Vastra Gotaland Region

Version No: 
Date: 
Clinical Investigation Plan 
Study Code: 
CIV-ID: 
LAGOM 
24-09-049056 
3.1 
2025-10-21 
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CLINICAL INVESTIGATION PLAN 
Longitudinal Approach to Generate positive 
cardiometabolic health Outcomes in severe Mental 
illness 
LAGOM 
 
CIV- 24-09-049056 
 
 
 
 
 
 
Version number: 3.1 
 
Date: 2025-10-21 
 
 
 
Sponsor: Västra Götalandsregionen 
 
 
 
Sponsor representative and 
Coordinating Investigator: 
Hemen Najar 

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Study Code: 
CIV-ID: 
LAGOM 
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Revision history 
 
Document 
version 
Date of Issue 
Summary of Change 
2.0 
2024-12-06 
The addition of a fifth exclusion criterion: 
5) Currently under compulsory care. 
This change should be reflected on page 10 (under Section 
1: Synopsis) and page 22 (under Section 6.3.2: Exclusion 
Criteria). 
The addition of: 
5) Under behandling med tvångsvård. 
This change should be reflected on page 13 (under Section 
Synopsis på Svenska). 
 
3.0 
2025-06-10 
Correcting the order of the references. 
Principle investigator has been changed for Öster to Lina 
Klysing and for Nordost to Elin Saari-Bladmyr. 
”psychiatric outpatient clinics” has been changed to 
“psychosis outpatient clinics” in the synopsis. 
“Descriptive cost” has been modified to “cost” throughout the 
document.  
“Accredited translators” has been changed to “Accredited 
interpreters” throughout the document” 
“At the first baseline” has been changed to “Before the first 
baseline.” throughout the document. 
Section 6.5, under care as usual: 
“Care as usual takes place over two visits, with some days' 
interval between them. During the first visit, which lasts 
approximately 45 minutes, the patient meets with the case 
manager. At the second visit, which also lasts approximately 
45 minutes” 
Has been changed to: 
“Care as usual takes place over two visits, which take place 
within 45 days. During the first visit, which lasts approximately 
60 minutes, the patient meets with the case manager. At the 

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second visit, which also lasts approximately 60 minutes” 
Following text has been added:  
”The blood test and physical examination provide the 
cardiometabolic risk indicator values relevant to this clinical 
trial. Only indicators obtained within the defined visit window 
will be included. This visit window spans 45 days before and 
after the second visit of the annual health check, which 
involves the physician. The window is designed to 
accommodate the realities of clinical practice, where it may 
not always be feasible for patients to complete the blood test 
or physical examination on the scheduled day. This flexibility 
ensures alignment with routine care. If a patient completes the 
blood test or undergoes the physical examination after the 
second visit, a follow-up physician visit is required to review 
the results and implement necessary management 
measures.” 
“As part of care as usual, the case manager sends all patients 
with self-assessment questionnaires (EQ-5D-5L, AUDIT-C, 
and a questionnaire on eating habits to be filled at home) and 
a letter with instructions for blood sample preparation” 
Has been changed to: 
“As part of care as usual, the case manager prepares for the 
annual health check by ordering blood tests, beginning to fill 
in the worksheet, and sending a letter to the patient with 
instructions for blood sample preparation. Depending on the 
case, the case manager may also send the patient self-
assessment questionnaires (EQ-5D-5L, AUDIT-C, and a 
questionnaire on eating habits to be completed at home)” 
The section describing the data collection procedure for the 
control group has been moved to follow directly after the 
description of care as usual, to improve the logical flow. 
Visits 1, 3, 5, and 7– “Two weeks before the annual health 
check with the physician” has been changed to “The annual 
health check with the case manager” 
Visits 2, 4, 6, and 8 – “The annual health check with the 
physician” has been changed to “The annual health check with 
the physician and case manager” 
Visit 1: A text clarification has been made, that written consent 
is obtained during the annual health check. 
“The participant completes the control version of the 
worksheet and undergoes a somatic examination, as 
outlined in Table 1, conducted by the case manager.” 
Has been changed to  
“The participant is interviewed according to the control 
version of the worksheet and undergoes a somatic 
examination, as outlined in Table 1, conducted by the case 

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manager.” 
Following text has been added: 
“In preparation for Visit 1, the case manager begins filling 
the worksheet for the annual health check by gathering 
information from various sources, including medical 
records, telephone interviews with the participant, or the 
case manager’s or physician’s prior knowledge of the 
patient.” 
Section 6.5, under intervention group: 
“After informed consent, the case manager will interview the 
participants with the intervention version of the worksheet.” 
Has been changed to 
“After informed consent, the case manager will continue 
interviewing the participants and fill in the intervention 
version of the worksheet.” 
A repetitive paragraph has been removed.   
Visits 1, 8, 15, and 22: – “Two weeks before the annual health 
check with the physician” has been changed to “The annual 
health check with the case manager” 
Visits 2, 9, 16, and 23 – The annual health check with the 
physician. “and the case manager” has been added. 
Under Visit 1:  
“At this visit, patients are screened for eligibility. If eligible, 
they are invited to join the intervention group by a member 
of the clinical trial team, and written consent is obtained. 
The participant completes the intervention version of the 
worksheet and undergoes a somatic examination, as 
outlined in Table 1, conducted by the case manager. A 
blood test is ordered according to clinical practice and 
should be completed before the baseline visit. The blood 
sample is collected following the standard clinical 
procedure used during routine annual health checks. 
Participants are examined using a body composition 
analyzer and complete the QRISK3 assessment with their 
case manager, as outlined in table 1.” 
Has been changed to  
“The same routine as in Visit 1 (baseline) for the control 
group, except for inviting to the intervention group and 
using the intervention version of the worksheet. If written 
consent is obtained, the participants are examined using a 
body composition analyzer by their case manager, as 
outlined in table 1. No study-specific procedures are 

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conducted before informed consent is obtained. However, 
in preparation for Visit 1, the case manager begins filling 
the worksheet for the annual health check by gathering 
information from various sources, including medical 
records, telephone interviews with the participant, or the 
case manager’s or physician’s prior knowledge of the 
patient.” 
Following text has been added to visit 2: 
“The physician fills in the QRISK3 algorithm with the 
participant.”  
Section 7.4: 
“the number of completed medical history protocols” has been 
changed to “the completed worksheets” 
Section 8.3: 
Following text has been removed “within one week” and 
the following text has been added: “The first and second 
checks are performed within 45 days of the second visit of 
the annual health check. However, during summer, 
Christmas, and other national holidays, these routines may 
require additional time due to limited staff availability and 
scheduling constraints.” 
Section 9.1: 
“One week” has been changed to “45 days” 
Section 14.1: 
“during the annual health checks” has been added to the 
sentence “If they are eligible, they will be invited to participate 
in the clinical trial” in the first paragraph. 
 
3.1 
2025-10-21 
“Care as usual” has been changed to “usual care” throughout 
the document. 
The terms “intervention group” and “control group” have been 
revised to “intervention clinics” and “control clinics,” 
respectively, where applicable. This change was made to 
improve clarity and accuracy in describing the trial’s cluster-
level design. The adjustment has been applied selectively—
only in contexts where “intervention clinics” and “control 
clinics” more appropriately reflect the organizational level of 
the intervention rather than the individual participant level. 
Table 1 
Changing “eating habits” to “Dietary habits” 
An update was made to specify the timing of data collection 

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for “Questions about participation in educational sessions and 
lifestyle sessions.” These assessments occur at baseline, 12 
months, 24 months, and 36 months. This information had 
been omitted in previous versions of the CIP and has now 
been added for completeness and clarity. 
6.3.2 Exclusion criteria 
Exclusion criteria, “Deemed unsuitable for inclusion at the 
discretion of the investigator” and “Previous participation in the 
clinical trial” have been clarified. 
 
 
 
 

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Table of Contents 
 
Signatures ................................................................................................................................. 9 
Contact information ................................................................................................................. 10 
Funding and research agreement ........................................................................................... 11 
List of used acronyms and abbreviations ................................................................................ 11 
1. 
Synopsis ................................................................................................................... 13 
Synopsis på Svenska .......................................................................................................... 16 
2. 
Identification and description of the investigational device ........................................ 19 
2.1. 
Description of the investigational device............................................................ 19 
2.2. 
Intended purposes ............................................................................................. 20 
2.3. 
Manufacturer of the investigational device ........................................................ 20 
2.4. 
Model/type ......................................................................................................... 20 
2.5. 
Summary of required training/experience needed ............................................. 21 
3. 
Background and justification for the design of the clinical trial .................................. 21 
3.1. 
Background ....................................................................................................... 21 
4. 
Risks and clinical benefits of the investigational device and clinical trial .................. 24 
4.1. 
Expected clinical benefits and risks ................................................................... 24 
4.2. 
Rationale for benefit-risk ratio ............................................................................ 24 
5. 
Objectives of the clinical trial ..................................................................................... 24 
5.1. 
The purpose of the clinical trial .......................................................................... 24 
5.2. 
Objectives .......................................................................................................... 25 
6. 
Design of the clinical trial .......................................................................................... 25 
6.1. 
General information ........................................................................................... 25 
6.2. 
Endpoints .......................................................................................................... 25 
6.3. 
Participants ....................................................................................................... 26 
6.4. 
Methods to minimize bias .................................................................................. 27 
6.5. 
Description of the clinical procedures and diagnostic methods relating to the 
clinical trial ...................................................................................................................... 28 
6.6. 
End of the clinical trial ....................................................................................... 33 
7. 
Quality control .......................................................................................................... 34 
7.1. 
Monitoring ......................................................................................................... 34 
7.2. 
Monitoring plan .................................................................................................. 34 
7.3. 
Source data ....................................................................................................... 34 
7.4. 
Quality assurance and quality control ............................................................... 34 
8. 
Statistical considerations........................................................................................... 35 

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8.1. 
Analytical procedures ........................................................................................ 35 
8.2. 
Sample size calculation ..................................................................................... 35 
8.3. 
Missing data ...................................................................................................... 36 
9. 
Data management and protection ............................................................................. 36 
9.1. 
Case Report Form and data cleaning ................................................................ 37 
9.2. 
Archiving ............................................................................................................ 37 
9.3. 
Data protection .................................................................................................. 37 
10. 
Amendments to the CIP ............................................................................................ 38 
11. 
Deviations from the CIP ............................................................................................ 38 
12. 
Device traceability and accountability ....................................................................... 38 
13. 
Statements of compliance ......................................................................................... 38 
13.1. 
Compliance to the investigational plan, good clinical practice, and regulations . 39 
13.2. 
Insurance ........................................................................................................... 39 
14. 
Informed consent process......................................................................................... 39 
14.1. 
General process for informed consent .............................................................. 39 
15. 
Adverse events, adverse device effects and device deficiencies .............................. 39 
15.1. 
Definitions .......................................................................................................... 40 
15.2. 
Recording and Reporting ................................................................................... 41 
16. 
Premature termination of the clinical trial .................................................................. 43 
17. 
Publication policy ...................................................................................................... 44 
18. 
References ............................................................................................................... 44 
19. 
Appendix ................................................................................................................... 46 
 

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Signatures 
Sponsor 
I am responsible for ensuring that this CIP includes all essential information to be able to 
conduct this clinical trial. I will submit the CIP and all other important clinical investigation- 
related information to the responsible investigator(s) so that they can conduct the clinical trial 
correctly. I am aware that it is my responsibility to hold the staff members who work with this 
clinical trial informed and trained. 
 
 
 
Sponsor representative and Coordinating Investigator signature 
Date 
 
 
Hemen Najar 
 
 
Principal Investigator 
I have read this CIP and agree that it includes all essential information to be able to conduct 
the clinical trial. By signing my name below, I agree to conduct the clinical trial in compliance 
with this Clinical trial plan, the Declaration of Helsinki, SS-EN ISO14155:2020 (Good Clinical 
Practice), and the current national and international regulations governing the conduct of this 
clinical trial. 
I will submit this CIP and all other important clinical trial-related information to the staff 
members who participate in this clinical trial, so that they can conduct the clinical trial 
correctly. I am aware of my responsibility to continuously keep the staff members who work 
with this clinical trial informed and trained. 
I am aware that quality control of this clinical trial will be performed in the form of monitoring, 
audit, and possibly inspection. 
 
 
 
 
 
Principal Investigator’s signature 
Date 
 
 
Printed name 

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Contact information 
 
Role 
Sponsor representative and Coordinating 
Investigator 
Hemen Najar, Consultant psychiatrist 
Department of Psychotic disorders 
Psykosmottagning Centrum, Kronhusgatan 
2G, plan 4, 411 13 Göteborg 
073 763 13 53 
Principal Investigator Centrum 
Eva Andreasson, Specialist nurse in 
psychiatric care 
Department of Psychotic disorders 
Psykosmottagning Centrum 
Kronhusgatan 2G, plan 4 
411 13 Göteborg 
070 242 67 97 
Principal Investigator Mölndal 
Erik Wålinder, Specialist nurse in 
psychiatric care 
Department of Psychotic disorders 
Psykosmottagning Mölndal 
Norra Ågatan 32 
431 35 Mölndal 
076 940 29 76 
Principal Investigator Hisingen 
Christina Hagberg, Specialist nurse in 
psychiatric care 
Department of Psychotic disorders 
Psykosmottagning Hisingen 
Polstjärnegatan 6 
417 52 Göteborg 
073 660 14 18 
Principal Investigator Väster 
Caroline Holmbom, Specialist nurse in 
psychiatric care 
Department of Psychotic disorders 
Psykosmottagning Väster 
Topasgatan 2 
421 48 Västra Frölunda 
076 949 43 08 
Principal Investigator Öster 
Lina Klysing, Specialist nurse in psychiatric 
care 
Department of Psychotic disorders 
Psykosmottagning Öster 
Lilla Munkebäcksgatan 4A 
416 72 Göteborg 
072 145 83 73 

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Principal Investigator Nordost 
Elin Saari-Bladmyr, Specialist nurse in 
psychiatric care 
Department of Psychotic disorders 
Psykosmottagning Nordost Byfogdegatan 3A 
415 05 Göteborg 
070 355 13 57 
Emergency contact details 
Hemen Najar, Consultant psychiatrist 
Department of Psychotic disorders 
Psykosmottagning Centrum, Kronhusgatan 
2G, plan 4, 411 13 Göteborg 
073 763 13 53 
 
Monitor 
To be decided 
 
Funding and research agreement 
This is an investigator-initiated clinical trial without any assistance or input from any 
company. 
 
The clinical trial has got research grants from Sahlgrenska University Hospital’s foundations, 
Göteborgs Läkaresällskap, Innovation fund, and Wilhelm and Martina Lundgren’s Science 
Foundation as well as from Västra Götalandsregionen and Sahlgrenska University Hospital. 
We will even apply for funding from ALF-medel and Forte. 
The clinical trial will be held in 6 outpatient clinics belonging to the Department of Psychotic 
Disorders in Gothenburg. No site agreement will be signed, as it is the same manager who is 
responsible for the study being carried out at all 6 sites. 
 
List of used acronyms and abbreviations 
 
 
Abbreviation 
Term/Explanation 
ADE 
Adverse Device Effect 
AE 
Adverse Event 
AUDIT-C 
Alcohol Use Disorders Identification Test-Concise 
B-HbA1c 
Blood Hemoglobin A1C 
BIA 
Bioelectrical Impedance Analysis 
BMI 
Body Mass Index 

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BMR 
Basal Metabolic Rate 
Case manager 
The person responsible for coordinating the patient’s care and 
treatment. This role may be filled by a nurse, assistant nurse, 
occupational therapist, or social worker 
CE 
Conformité Européenne, which is French for "European Conformity" 
CIP 
Clinical Investigation Plan 
CVD 
Cardiovascular Disease 
DBP 
Diastolic Blood Pressure 
DD 
Device Deficiency 
eCRF 
electronic Case Report Form 
Euro 
the single European currency 
FFM 
Fat-Free Mass (FFM) 
fP-TAG 
fasting Plasma Triacylglycerol 
IB 
Investigator’s Brochure 
ICD 
International Classification of Diseases 
ID 
Identification 
ICER 
Incremental cost-effectiveness ratio 
IFU 
Instructions For Use 
ISF 
Investigation Site File 
LAGOM 
Longitudinal Approach to Generate positive cardiometabolic health 
Outcomes in severe Mental illness 
MAR 
Missing At Random 
MCAR 
Missing Completely At Random 
MDCG 
Medical Device Coordination Group 
MDR 
Medical Device Regulation 
MI 
Multiple Imputation 
ML 
Maximum Likelihood 
MNAR 
Missing Not At Random 
P-ALP 
Plasma Alkaline Phosphatase 
P-ALT 
Plasma Alanine Transaminase 
P-AST 
Plasma Aspartate Transaminase 
P-CRP 
Plasma C Reactive Protein 
P-HDL-C 
Plasma High Density Lipoprotein Cholesterol 
P-LDL-C 
Plasma Low Density Lipoprotein Cholesterol 

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P-TChol 
Plasma Total cholesterol 
QALY 
Quality-Adjusted Life Year 
REDCap 
Research Electronic Data Capture 
Research team 
The research team is comprised of research nurses, research 
assistants, case managers, psychiatrists, physiotherapists, and licensed 
psychologists 
SADE 
Serious Adverse Device Effect 
SAE 
Serious Adverse Event 
SBP 
Systolic Blood Pressure 
SCORE2 
Systematic COronary Risk Evaluation 2 
SS-EN ISO 
Swedish Standard - European standard International Organization for 
Standardization 
UKCA 
United Kingdom Conformity Assessed 
WHR 
Waist-hip ratio 
1. Synopsis 
 
Background and rationale: 
Cardiometabolic diseases are prevalent among individuals 
with psychotic disorders, significantly contributing to their 
shorter lifespan, reduced quality of life, and economic 
impact on individuals and society. To improve 
cardiometabolic health, effective and individualized 
interventions are crucial. Psychosis outpatient clinics are 
ideal for these interventions due to regular patient visits 
and the availability of diverse health professionals. We 
have developed and want to test a comprehensive 
intervention program to improve cardiometabolic health, 
enhance quality of life, and promote healthy lifestyles 
specifically for people with psychotic disorders at 
psychosis outpatient clinics in Gothenburg. 
This longitudinal, multicenter, naturalistic, multicomponent, 
parallel-group, quasi-experimental, superiority, case-control 
study, LAGOM (Longitudinal Approach to Generate 
positive cardiometabolic health Outcomes in severe Mental 
illness) aims to include 644 individuals with psychotic 
disorders from six outpatient clinics in the Department of 
Psychotic Disorders at Sahlgrenska University Hospital in 
Gothenburg. Two outpatient clinics will provide the 
LAGOM-intervention, while the other clinics will serve as 
controls, offering "usual care". The intervention group 

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will receive multidisciplinary support integrated into the 
routine clinical procedures. The intervention includes 
regular follow-ups and use of motivational tools, including 
body composition analyzer and cardiovascular risk 
prediction algorithm (QRISK3). 
If the intervention effectively improves cardiometabolic 
health, enhances quality of life for this vulnerable group, 
and proves cost-effective, it can serve as a model program 
for implementation in Region Västra Götaland. 
Investigational device: 
In this clinical trial, we will use two investigational devices 
that are also visual in the sense that they can create a 
shared picture, between participants and healthcare 
providers, of the participants’ well-being. These devices are 
motivational tools and are focused on cardiometabolic 
health, in line with the project’s overall purpose. These are 
called QRISK3 algorithm and TANITA body composition 
analyzer, a special type of scale that gives a more holistic 
view of body composition. 
Number of participants: 
644 
Inclusion criteria: 
1) Adults, ≥18 years, meeting ICD-10 diagnostic criteria for 
any one of the schizophrenia spectrum disorders (F20-F25 
or F28-F29). 
2) Has the ability to sign informed consent. 
Exclusion criteria: 
1) Having an electrical medical implant like pacemaker or 
other mechanical implants. 
2) Pregnant women. 
3) Deemed unsuitable for inclusion at the discretion of the 
investigator. 
4) Previous participation in the clinical trial. 
5) Currently under compulsory care. 
Study objectives: 
Primary objective: To evaluate whether the intervention is 
superior to usual care in lowering levels of cardiometabolic 
risk indicators after 36 months. 
Secondary and exploratory objective(s): 
To assess if the intervention is superior to usual care in 
lowering the risk of cardiovascular disease (CVD) after 36 
months. 
To evaluate whether the intervention is superior to usual 
care in enhancing the quality of life (EQ-5D-5L) after 36 
months. 

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To evaluate whether the intervention reduces high- 
sensitivity CRP and HbA1c after 36 months. 
To determine the cost per participant and perform a cost- 
effectiveness analysis where cost neutrality for the 
intervention is a positive outcome. 
To evaluate whether the intervention improves the targeted 
lifestyle after 36 months. 
To explore the total number and the type of intervention 
sessions, and the average time interval between 
consecutive sessions needed per year to achieve a change 
in the targeted lifestyle. 
To investigate whether participation in educational 
sessions by participants and their relatives will motivate 
participants to adopt a new lifestyle 
Study endpoints: 
Primary endpoint: 
Cardiometabolic risk indicators: 
• 
Body mass index (BMI) (kg/m2) 
• 
Waist-hip ratio (WHR) 
• 
Systolic blood pressure (SBP) mm Hg 
• 
Diastolic blood pressure (DBP) mm Hg 
• 
Triacylglycerol/high density lipoprotein-cholesterol 
ratio (TAG/HDL-C ratio) 
• 
Total cholesterol/HDL-C ratio (TChol/HDL-C ratio) 
• 
Plasma glucose (mmol/L) 
Secondary and exploratory endpoint(s): 
• 
CVD events or reduction in CVD risk scores 
according to SCORE2 
• 
Blood samples 
o High-sensitivity CRP (mg/L) 
o HbA1c (mmol/mol) 
• 
Questionnaires 
o Quality of life according to EQ-5D-5L 
o Alcohol habits according to AUDIT-C 
o Tobacco habits 
o Eating habits 
o Physical activity 
• 
Cost-utility analysis 
o Cost description in SEK and EURO 
o Quality-Adjusted Life Years (QALYs) at baseline 
and at 12, 24, and 36 months 

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o Incremental cost-effectiveness ratio (ICER), 
comparing the costs between the control and 
intervention groups at baseline and after 36 
months 
Planned duration of the 
clinical trial: 
Q1 2025 – Q4 2029 
 
Synopsis på Svenska 
 
Bakgrund and rational: 
Kardiometabola sjukdomar är utbredda bland personer 
med psykossjukdomar, vilket väsentligt bidrar till deras 
kortare livslängd, minskade livskvalitet och ekonomiska 
påverkan på individer och samhälle. För att förbättra den 
kardiometabola hälsan är effektiva och individanpassade 
interventioner avgörande. Psykos öppenvårdsmottagningar 
är idealiska för dessa insatser på grund av regelbundna 
patientbesök och tillgången till olika hälso- och 
sjukvårdpersonal. Vi har utvecklat och vill testa ett 
omfattande interventionsprogram för att förbättra 
kardiometabol hälsa, höja livskvaliteten och främja en 
hälsosam livsstil specifikt för personer med 
psykossjukdomar vid psykos öppenvårdsmottagningar i 
Göteborg. 
Denna longitudinella, multicenter, naturalistiska, 
multikomponent, parallell-grupp, quasi-experimentella, 
överlägsenhet, fall-kontrollstudie, LAGOM (Longitudinal 
Approach to Generate positive cardiometabolic health 
Outcomes in severe Mental illness) kommer att inkludera 
644 individer med psykossjukdomar från sex 
öppenvårdsmottagningar inom Psykiatri Psykos vid 
Sahlgrenska universitetssjukhuset i Göteborg. Två av 
mottagningarna genomför LAGOM-interventionen och vid 
övriga mottagningar rekryteras kontroller som får vanlig 
vård. Interventiongruppen kommer att få multidisciplinärt 
stöd integrerat i de rutinmässiga kliniska procedurerna. 
Interventionen inkluderar regelbundna uppföljningar och 
användning av motiverande verktyg, inklusive 
kroppsanalysvåg och algoritm för förutsägelse av 
kardiovaskulär risk (QRISK3). 
Om interventionen effektivt förbättrar kardiometabol hälsa, 
förbättrar livskvalité för denna sårbara grupp och visar sig 
vara kostnadseffektiv kan den fungera som ett 
modellprogram för implementering inom Västra Götalands 
Regionen. 

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Medicinsk teknisk produkt: 
I den här kliniska prövningen kommer vi att använda två 
medicintekniska produkter som också är visuella i den 
meningen att de kan skapa en delad bild, mellan 
försökspersoner och vårdgivare, av deltagarnas 
välbefinnande. Dessa enheter är motiverande verktyg och 
är fokuserade på kardiometabolisk hälsa, i linje med 
projektets övergripande syfte. Dessa kallas QRISK3 
algoritm och TANITA kroppsanalysvåg, en speciell typ av 
våg som ger en mer helhetssyn på 
kroppssammansättningen. 
Antal försökspersoner: 
644 
Inklusionskriterier: 
1) Vuxna, ≥18 år, som uppfyller ICD-10 diagnostiska 
kriterier för någon av schizofrenispektrumsyndrom och 
andra psykoser (F20-F25 eller F28-F29). 
2) Har förmåga att underteckna informerat samtycke. 
Exklusionskriterier: 
1) Att ha ett elektriskt medicinskt implantat som pacemaker 
eller andra mekaniska implantat. 
2) Gravida kvinnor. 
3) Anses olämplig för inkludering efter utredarens 
bedömning. 
4) Tidigare deltagande i prövningen. 
5) Under behandling med tvångsvård. 
Syfte: 
Primärt syfte: Att utvärdera om interventionen är 
överlägsen vanlig vård för att sänka nivåer av 
kardiometabola riskindikatorer efter 36 månader. 
Sekundära och explorativa syften: 
Att bedöma om interventionen är överlägsen vanlig vård för 
att sänka risken för hjärtkärlsjukdom efter 36 månader. 
Att utvärdera om interventionen är överlägsen vanlig vård 
för att höja livskvaliteten (EQ-5D-5L) efter 36 månader. 
Att utvärdera om interventionen minskar högkänslig CRP 
och HbA1c efter 36 månader. 
Att bestämma kostnaden per försöksperson och utföra en 
kostnadseffektivitetsanalys där kostnadsneutralitet för 
interventionen är ett positivt resultat. 
Att utvärdera om interventionen förbättrar den riktade 
livsstilen efter 36 månader. 

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Att utforska det totala antalet och typen av 
interventionssessioner, och det genomsnittliga 
tidsintervallet mellan på varandra följande sessioner som 
behövs per år för att uppnå en förändring i den riktade 
livsstilen. 
Att undersöka om deltagande i utbildningstillfällen av 
försökspersoner och deras anhöriga kommer att motivera 
försökspersonerna att anta en ny livsstil. 
Utfallsmått: 
Primära utfallsmått: 
Kardiometabola riskindikatorer: 
• 
Body mass index (BMI) (kg/m2) 
• 
Waist-hip ratio (WHR) 
• 
Systolic blood pressure (SBP) mm Hg 
• 
Diastolic blood pressure (DBP) mm Hg 
• 
Triacylglycerol/high density lipoprotein-cholesterol 
ratio (TAG/HDL-C ratio) 
• 
Total cholesterol/HDL-C ratio (TChol/HDL-C ratio) 
• 
Plasma glucose (mmol/L) 
Secondära och exploratorativa utfallsmått: 
• 
Händelser av hjärtkärlsjukdom eller minskning av 
riskpoäng för hjärtkärlsjukdom enligt SCORE2 
• 
Blood samples 
o Högkänslig CRP (mg/L) 
o HbA1c (mmol/mol) 
• 
Questionnaires 
o Livskvalitet enligt EQ-5D-5L 
o Alkoholvanor enligt AUDIT-C 
o Tobaksrökning och snusvanor 
o Matvanor och Kostindex 
o Fysisk aktivitet 
• 
Cost-utility analysis 
o Kostnadsbeskrivning i SEK och EURO 
o Quality-Adjusted Life Years (QALYs) vid 
baslinjen samt vid 12, 24 och 36 månader 
o Incremental cost-effectiveness ratio (ICER) där 
vi jämför kostnaderna mellan kontroll- och 
interventionsgruppen vid baslinjen och efter 36 
månader 
Planerad varaktighet av den 
Q1 2025 – Q4 2029 
kliniska prövningen: 

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2. Identification and description of the investigational device 
2.1. 
Description of the investigational device 
QRISK®3-2018 risk calculator 
The QRISK3 algorithm was developed in 2007 by a research group in Great Britain and 
updated in 2017 to the current version-QRISK3 (https://qrisk.org) (1). QRISK3 is a software 
that calculates a person’s risk of developing a heart attack or stroke over the next 10 years. 
QRISK3 is United Kingdom Conformity Assessed (UKCA)-marked. The UKCA marking set 
up by the UK is intended to completely replace CE marking in the UK. QRISK3 considers 
having psychotic disorders and treatment with atypical antipsychotics as independent risk 
factors. In addition, QRISK3 estimates the risk over a wide age range (25–84 years). 
QRISK3 is included in the intervention for use in motivational work because it illustrates how 
reducing the number of cigarettes, losing weight, and improving blood pressure and blood 
lipids can reduce the absolute risk of CVD. In addition, QRISK3 illustrates the interactive and 
synergistic relation between the various cardiometabolic risk factors. 
The calculator uses 
• 
the QRISK3 algorithm, version 2018.0 
• 
the BMI predictor algorithm, version 2013.0 
• 
the cholesterol ratio predictor algorithm, version 2013.0 
• 
the SBP predictor algorithm, version 2013.0 
• 
the University of Nottingham Townsend score reference table, version 2018.0 
 
Body composition analyzer 
TANITA body composition analyzer calculates body composition using Dual Frequency 
Bioelectrical Impedance Analysis (BIA). The device is CE certified as a class IIa medical 
device. Safe, low-level electrical signals are passed through the body via the TANITA foot 
pads on the monitor platform. The signal can flow easily through fluids in muscles and other 
body tissue but meets resistance as it passes through body fat, because body fat only 
contains small amount of fluid. This resistance is called impedance. The impedance readings 
are then entered into medically researched mathematical formulas to calculate body 
composition. 
TANITA is intended for persons aged 5-99 years. This Tanita Body Composition Analyzer is 
clinically proven to deliver accurate, reliable, and highly repeatable results. It is used globally 
by health, research, and medical professionals for: 
• 
Medical screening and health assessments 
• 
Monitoring the progress of weight loss during treatment relating for lifestyle diseases 
such as diabetes, hyperlipidemia, bariatric surgery, hypertension, and fatty liver 
disease 
The analyzer measures weight, impedance, and estimates BMI, total body fat percent and 
mass, total body water percent and mass, total body muscle mass, bone mass, visceral fat, 

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basal metabolic rate (BMR), and fat-free mass (FFM) using BIA. It is suitable for healthy 
children (ages 5-17) and adults with varying levels of physical activity, ranging from inactive 
to highly active lifestyles. 
2.2. 
Intended purposes 
In this clinical trial, QRISK3 will be used as a motivational tool to encourage lifestyle changes 
such as reducing smoking, exercising, and improving diet. These healthier habits can lower 
both absolute and relative risks of CVD, either directly by reducing smoking or indirectly by 
reducing factors like blood pressure, BMI, and blood lipids. Additionally, QRISK3 is intended 
to help participants understand the importance of managing these factors to reduce 
cardiovascular risk. 
QRISK3 highlights the interactive and synergistic relation between various cardiometabolic 
risk factors. It shows how small improvements in multiple risk factors can significantly reduce 
overall cardiovascular risk. This makes QRISK3 a valuable visual tool, fostering a shared 
understanding between participants and healthcare providers about the participant’s health. It 
also conveys that even modest changes in different risk factors can be beneficial. Since 
QRISK3 estimates risk over the next 10 years, it may indicate to the participants that they 
have time to make meaningful changes without undue pressure. 
The TANITA body composition analyzer used in this clinical trial further supports 
participants in making lifestyle changes, aligning with the device’s overall intended purpose. 
Importantly, the results from QRISK3 and TANITA will not influence medical decisions made 
by physicians or healthcare professionals. These results will not be shared with other health 
units, such as primary health care centers. Instead, they will be communicated exclusively to 
the participants, to motivate lifestyle changes and support healthcare professionals’ efforts to 
improve the participants’ cardiometabolic health. 
2.3. 
Manufacturer of the investigational device 
2.3.1 QRISK®3-2018 risk calculator 
Name: ClinRisk Ltd. 
Address: 13-19 Queen St, Leeds, LS1 2TW 
Contact: enquiries@clinrisk.co.uk 
6.3.1. 
Body composition analyzer DC-430MA 
Name: TANITA Corporation 
Address: 1-14-2 Maeno-cho, Itabashi-ku, Tokyo 174-8630 Japan 
Contact, phone number: +81-(0)3-3968-7048 
2.4. 
Model/type 
QRISK3 algorithm: version 2018.0 
TANITA body composition analyzer: Model DC-430MA 

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2.5. 
Summary of required training/experience needed 
The clinical trial team will undergo both theoretical and practical training before using the 
QRISK3 software and TANITA body composition analyzer. 
3. Background and justification for the design of the clinical trial 
3.1. 
Background 
People with schizophrenia and schizophrenia-spectrum disorders (psychotic disorders) are at 
higher risk for cardiometabolic diseases such as CVD, obesity, and type 2 diabetes mellitus 
compared with the general population (2). These illnesses can lead to premature death, and 
people with psychotic disorders have a life expectancy that is 20 years shorter than that of 
the general population in Sweden (3). This mortality gap has increased in recent decades 
(4). Cardiometabolic diseases also lead to a poorer quality of life for these individuals (5) and 
affect the economy through loss of production and increased healthcare costs (6). 
Several factors increase the risk for these cardiometabolic diseases in people with psychotic 
disorders, including the phenomenology of the illness, genetic predisposition, use of 
psychotropic drugs, unhealthy eating habits, lack of physical activity, tobacco smoking, and 
risky alcohol use (7). A lower quality of somatic care for people with psychotic disorders 
compared with the general population is well documented and plays an important role (7, 8). 
Many of these risk factors can be influenced by the choice of psychotropic drugs and 

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interventions to change unhealthy lifestyles. However, people with psychotic disorders, 
especially schizophrenia, find it difficult to change their lifestyle because of difficulties with 
memory and executive functions, as well as persistent psychiatric symptoms that prevent 
them from adopting new behaviors (9). Even when learning a new lifestyle, people with 
schizophrenia have difficulty maintaining it because of illness, cognitive impairment, and side 
effects of psychotropic medications. 
In addition to the difficulties faced by people with psychotic disorders, there are several 
shortcomings in health care. Healthcare professionals do not consider the vulnerability of 
individuals with psychosis and place high demands on these individuals to follow the same 
recommendations as for the public when it comes to changing lifestyles. These 
recommendations are often given in the form of concise standardized advice, which, 
according to The Swedish National Board of Health and Welfare (10), should be 
complemented by more extensive measures. Such measures may include advisory sessions 
that are adapted to the individual’s specific needs and include motivational strategies as well 
as various tools and aids, or qualified advisory sessions that are similar to advisory sessions 
but are more time-consuming and require staff to have in-depth knowledge of the subject and 
are trained in the method used for the session. Another shortcoming in healthcare is the lack 
of educational programs for both individuals with psychotic disorders and healthcare 
professionals, to inform about the relation between psychotic disorders, lifestyle choices and 
the cardiometabolic profile. This profile includes development over time or the collective 
effect of different cardiometabolic parameters such as weight parameters (waist 
circumference and BMI), blood sugar, blood lipids, and blood pressure. There is also a large 
variation among healthcare professionals regarding follow-up and level of knowledge 
regarding the evaluation of deviations in the cardiometabolic profile and lifestyle habits of 
individuals with psychotic disorders. In psychiatry, there are recommendations to carry out 
annual physical health checks, but there are no clear guidelines for these health checks nor 
follow-up guidelines. These guidelines would ensure the application of interventions aimed at 
improving the cardiometabolic profile and lifestyles. This has been noticed by the Swedish 
National Board of Health and Welfare in its report on the national evaluation of care and 
support for schizophrenia and schizophrenia-spectrum disorders – 2022 (11). Finally, the 
collaboration between psychiatry and primary health care centers needs to be strengthened 
to improve the health of people with psychotic disorders. 
Some intervention programs succeeded in improving certain components of the 
cardiometabolic profile in individuals with psychotic disorders. An example is the ACHIEVE 
trial (12) which lasted 18 months and showed that tailored interventions can help people with 
psychotic disorders lose weight. Two other studies lasting 30 months showed improvement 
in all cardiovascular risk factors  (13) and reduction in the risk of type 2 diabetes in people 
with schizophrenia (14). 
Although some intervention studies have shown positive results, only a few were naturalistic 
(13-15) while most intervention studies were designed in a way that limited their effect on the 
individual’s health in everyday clinical practice. Most studies focused on individual lifestyle 
factors and individual cardiometabolic risk factors rather than the overall cardiometabolic 

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profile and aggregate cardiovascular risk estimate (12-14, 16-19). In addition, most studies 
had short intervention periods (16-20), typically one year or less, which did not provide 
sufficient time to achieve clinically significant improvements in risk factors except for the 
CRESSOB study (15). An additional challenge was that the health programs often did not 
take into account how care is delivered in practice, had few patients per healthcare staff (15, 
17, 18, 20), and used methods that are not sustainable in the long term, such as providing 
breakfast and lunch for participants (12), evaluating grocery shopping and cooking through 
home visits, as well as coaching physical activity at home (20). Many intervention studies 
also lacked education for patients and staff about the relation between psychotic disorders, 
the cardiometabolic profile, and lifestyle choices (12, 15, 16). Previous studies had limited 
inclusion criteria (12-18, 20). Furthermore, most did not consider improvement in the 
diagnosis and treatment of cardiometabolic abnormalities, which is a well-documented 
problem (12-14, 16-18). 
The LAGOM project (Longitudinal Approach to Generate positive cardiometabolic health 
Outcomes in severe Mental illness) has been designed to improve the evaluation of 
cardiometabolic health in people with psychotic disorders. LAGOM is integrated into the daily 
clinical routine of psychiatry in Gothenburg. This integration enables application of the 
method in the same clinical environment. The project focuses on the overall cardiometabolic 
profile and spans 36 months ± 6 months with broad inclusion criteria. LAGOM is an 
individually tailored program that aims at gradual improvements in lifestyle habits. In addition, 
the program improves communication with primary health care centers to optimize diagnosis 
and treatment of cardiometabolic abnormalities. It also offers education for participants, their 
relatives, and healthcare professionals about the relation between psychotic disorders, the 
cardiometabolic profile, and lifestyle choices. 
At the clinic, we possess clinical and research expertise in using tools that facilitate mutual 
understanding between healthcare providers and patients regarding the patients’ health 
conditions. For instance, in a quality improvement and research project, we assessed a 
specific patient-centered technical feature known as a "dashboard." It promoted feedback- 
informed care as it enabled us to visualize the outcomes of patients’ annual health checks, 
facilitating discussions between healthcare providers and patients (21). 
In this project, we will use two other tools that are also visual in the sense that they can 
create a shared picture, between patients and healthcare providers, of the patients’ well-
being. In our clinical trial these are focused on cardiometabolic health, in line with the 
project’s overall purpose. These motivational tools are called QRISK3 algorithm and body 
composition analyzer, a special type of scale that gives a more holistic view of body 
composition. See below for a more detailed description. 
With over 3,000 individuals receiving care within the Department of Psychotic Disorders in 
Gothenburg, the need for a health promotion program is acute and extensive. However, 
there is still a lack of knowledge about the effect of comprehensive naturalistic interventions 
such as LAGOM to improve cardiometabolic health, enhance quality of life, and reduce the 
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4. Risks and clinical benefits of the investigational device and 
clinical trial 
4.1. 
Expected clinical benefits and risks 
We are not aware of any risks with using the QRISK3 algorithm or the body composition 
analyzer. Since the clinical trial is integrated into routine clinical practice, the risks are no 
greater than those typically encountered during usual care. However, there is a concern that 
participants at the intervention clinics may need to attend additional outpatient clinic visits, 
which could require more time and energy and potentially impact their compliance with the 
clinical trial. To mitigate this, participants will be exempt from the costs of these visits and will 
receive bus tickets to cover transportation for the additional visits associated with the 
intervention. 
The LAGOM program is a proactive response to challenges seen in previous intervention 
studies and clinical settings, aiming to mitigate cardiometabolic risk factors and improve 
lifestyle habits for individuals with psychotic disorders. It integrates seamlessly into clinical 
practice at the Department of Psychotic Disorders in Gothenburg, focusing on patient and 
family education and professional development for healthcare staff. These efforts are geared 
towards heightening awareness regarding the intricate interplay between psychotic disorders, 
cardiometabolic health, and lifestyle choices. LAGOM focuses on overall cardiometabolic 
health and addresses underdiagnosis and undertreatment of cardiometabolic abnormalities. 
Its potential long-term impact includes enhancing quality of life, promoting efficient resource 
allocation, addressing cardiometabolic disease risks, and fostering holistic well-being. If the 
intervention effectively improves cardiometabolic health, enhances quality of life for this 
vulnerable group, and proves cost-effective, it can serve as a model program for 
implementation in Region Västra Götaland. The clinical trial also includes collaboration with 
the schizophrenia association in Gothenburg to strengthen communication with and potential 
impact for end users. 
4.2. 
Rationale for benefit-risk ratio 
Since we cautiously assume that there are no risks involved in participating in the 
intervention, the risks are outweighed by the clinical and scientific value. Expected benefit at 
individual and group level consists in increased knowledge about the prevention and 
treatment of cardiometabolic abnormalities in people with psychotic disorders. The results 
have the potential to improve healthcare for the participants but also others who are treated 
for the same disease. The utility aspect thus prevails. 
5. Objectives of the clinical trial 
5.1. 
The purpose of the clinical trial 
The overall aim of the clinical trial is to improve cardiometabolic health, promote healthy 
lifestyles, and enhance quality of life in individuals with psychotic disorders. 

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5.2. 
Objectives 
Primary objectives 
To evaluate whether the intervention is superior to usual care in lowering levels of 
cardiometabolic risk indicators after 36 months. 
Secondary and exploratory objectives 
To assess if the intervention is superior to usual care in lowering the risk of CVD after 36 
months. 
To evaluate whether the intervention is superior to usual care in enhancing the quality of life 
(EQ-5D-5L) after 36 months. 
To evaluate whether the intervention reduces high-sensitivity CRP and HbA1c after 36 
months. 
To determine the cost per participant and perform a cost-effectiveness analysis where cost 
neutrality for the intervention is a positive outcome. 
To evaluate whether the intervention improves the targeted lifestyle after 36 months. 
To explore the total number and the type of intervention sessions, and the average time 
interval between consecutive sessions needed per year to achieve a change in the targeted 
lifestyle. 
To investigate whether participation in educational sessions by participants and their relatives 
will motivate participants to adopt a new lifestyle 
6. Design of the clinical trial 
6.1. 
General information 
The LAGOM clinical trial is a longitudinal, multicenter, naturalistic, multicomponent, parallel- 
group, quasi-experimental, superiority, case-control clinical trial. 
6.2. 
Endpoints 
6.2.1. 
Primary endpoint 
Cardiometabolic risk indicators at 36 months compared with baseline: 
• 
Body mass index (BMI) (kg/m2) 
• 
Waist-hip ratio (WHR) 
• 
Systolic blood pressure (SBP) mm Hg 
• 
Diastolic blood pressure (DBP) mm Hg 
• 
Blood samples 
o Triacylglycerol/high density lipoprotein-cholesterol ratio (TAG/HDL-C ratio) 
o Total cholesterol/HDL-C ratio (TChol/HDL-C ratio) 
o Plasma glucose (mmol/L) 
6.2.2. 
Secondary and exploratory endpoints 

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• 
CVD events or reduction in CVD risk scores according to SCORE2 
• 
Blood samples 
o High-sensitivity CRP (mg/L) 
o HbA1c (mmol/mol) 
• 
Questionnaires 
o Quality of life according to EQ-5D-5L 
o Alcohol habits according to AUDIT-C 
o Tobacco habits 
o Eating habits 
o Physical activity 
• 
Cost-utility analysis 
o Cost description in SEK and EURO 
o Quality-Adjusted Life Years (QALYs) at baseline and at 12, 24, and 36 months 
o Incremental cost-effectiveness ratio (ICER), comparing the costs between the 
control and intervention clinics at baseline and after 36 months 
6.3. 
Participants 
6.3.1. 
Inclusion criteria 
1) Adults, ≥18 years, meeting ICD-10 diagnostic criteria for any one of the schizophrenia 
spectrum disorders (F20-F25 or F28-F29). 
2) Has the ability to sign informed consent. 
6.3.2. 
Exclusion criteria 
1) Having an electrical medical implant like pacemaker or other mechanical implants. 
2) Pregnant women. 
3) Deemed unsuitable by the investigator (A person may be deemed unsuitable for participation 
in the trial by the clinical investigation team member, based on factors that may affect the 
ability to participate safely and reliably. Such factors may include, but are not limited to, 
physical disability that hinder participation, or practical challenges such as long travel 
distance to the trial site. The assessment is made on an individual basis and aims to ensure 
both patient safety and trial integrity). 
4) Prior participation in the LAGOM trial during a previous inclusion cycle (i.e., participants can 
only be included once during the trial period). 
5) Currently under compulsory care. 
6.3.3. 
Investigation population 
All eligible patients visiting one of the six outpatient clinics affiliated with Sahlgrenska 
University Hospital will be invited to participate in the clinical trial during their annual health 
checks. Inclusion will proceed consecutively until we reach the specified number of 
participants at both the intervention and control clinics. The patients are called based on their 
birth month, meaning that after a full year, all patients following the schedule have been 
asked to participate in the clinical trial. As the schedule is not always followed in practice, the 
recruitment period is expected to last longer than 12 months. 

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The intervention group (n=157) will be recruited from two psychosis outpatient clinics at the 
Department of Psychotic Disorders (Centrum and Mölndal) with a total of over 650 listed 
patients. The control group (n=487) will be recruited from four other psychosis outpatient 
clinics (Hisingen, Nordost, Väster, and Öster) with a total of over 2000 listed patients. The 
target group for these outpatient clinics includes individuals who have psychotic disorders and 
who live within the respective catchment areas, which have  a total of 768,574 inhabitants 
according to the population statistics from Statistics Sweden as of December 31, 2023 (22). 
6.3.4. 
Criteria and procedures for participant withdrawal or 
discontinuation 
Participants can discontinue their participation in the clinical trial at any time without any 
consequence to his/her continued treatment. 
If the participant discontinues the clinical trial, follow-up of this participant will be performed 
according to the clinic’s routine. 
Discontinuation criteria for individual participants: 
• 
Inappropriate enrollment (violation of inclusion/exclusion criteria) 
• 
Withdrawal of consent 
• 
Pregnancy 
• 
Receiving an electrical medical implant, such as a pacemaker, or other mechanical 
implants 
• 
Relocating to another city or country, or being registered at a different outpatient clinic 
The reason for discontinuation should be recorded in the eCRF. 
6.4. 
Methods to minimize bias 
In this clinical trial, possible sources of bias have been identified and strategies to minimize 
them have been implemented: 
Selection Bias: The psychosis clinics are located in different socio-economic areas with 
diverse ethnic groups, due in part to immigration, and there are variations in patients’ 
language skills. To minimize bias, we will stratify the data and adjust for confounders in the 
analysis, such as socioeconomic status and ethnicity. Accredited interpreters, familiar with 
both patients and healthcare providers, will be used as part of standard care practice. 
Including outpatient clinics with a majority of immigrant populations helps reduce selection 
bias, as these clinics represent a crucial part of the target population. 
Confounding Bias: Including a diverse sample addresses confounding bias, as factors like 
socioeconomic status and ethnicity can influence cardiometabolic risk. Adjusting for these 
variables during data analysis will further mitigate confounding effects. 
Information Bias: To minimize information bias, a standardized medical history protocol for 
data collection has been developed. Additionally, blood pressure equipment will be calibrated 
and examined annually. In cases of missing or incorrect data in the protocols, research 
nurses and assistants will rectify these during initial and secondary reviews before data entry. 

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Recall Bias: To reduce recall bias, information prone to this error will be cross-checked with 
medical records to ensure accuracy. 
Question Order Bias: The order of questions has been carefully considered to minimize the 
impact of question order bias. 
Performance Bias: To ensure consistency in the intervention across healthcare providers, a 
flowchart and standardized procedures will be used in all intervention outpatient clinics. 
Training workshops will also be conducted to maintain uniformity. A medical history protocol 
will standardize data collection for both the intervention and control groups. 
Attrition Bias: Attrition bias is expected to be minimal in the intervention group due to the 
individualized nature of the intervention methods. However, it cannot be completely ruled out 
in the control group. 
6.5. 
 Description of the clinical procedures and diagnostic methods relating 
to the clinical trial 
Usual care: Usual care describes the present health care situation for all individuals with 
psychotic disorders in Gothenburg. In Sweden, a comprehensive healthcare system ensures 
that all citizens are registered with a primary health care center, which assumes 
responsibility for addressing abnormal cardiometabolic risk factors. Even patients receiving 
specialist psychiatric care remain linked to their primary health care centers. Presently, 
individuals with psychotic disorders in Gothenburg undergo an annual health check, 
constituting the standard "usual care" practice. Usual care takes place over two visits, which 
take place within 45 days. During the first visit, which lasts approximately 60 minutes, the 
patient meets with the case manager. At the second visit, which also lasts approximately 60 
minutes, the patient meets with both the case manager and the psychiatrist or attending 
physician (henceforth referred to both as the physician). 
Usual care includes ordering fasting blood samples and physical examinations such as blood 
pressure measurement and weight assessment. The results of these tests and examinations 
are evaluated by the physician by comparing them to established reference intervals, which 
serve as the primary evaluation tool. Sometimes the physician uses risk algorithms for future 
CVD as Systematic COronary Risk Evaluation 2 (SCORE2) (23). 
The blood test and physical examination provide the cardiometabolic risk indicator values 
relevant to this clinical trial. Only indicators obtained within the defined visit window will be 
included. This visit window spans 45 days before and after the second visit of the annual 
health check, which involves the physician. The window is designed to accommodate the 
realities of clinical practice, where it may not always be feasible for patients to complete the 
blood test or physical examination on the scheduled day. This flexibility ensures alignment 
with routine care. If a patient completes the blood test or undergoes the physical examination 
after the second visit, a follow-up physician visit is required to review the results and 
implement necessary management measures. 
Depending on the physician’s assessment, further management may be considered, which 
could include referral to the primary health care center. Occasionally, discussions regarding 
lifestyle factors, particularly physical activity, diet, and substance use (such as tobacco and 

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alcohol), are initiated during these appointments.  
In cases where the case manager or the physician identifies deviant lifestyle habits, they 
offer the patient simple advice. Additionally, patients may be referred to a health promoter for 
support in reducing tobacco smoking, receiving dietary guidance, participating in group 
physical activities (e.g., pole walking or water aerobics), or consulting with a dietitian or 
primary health care center for further assistance. 
The total clinical trial is scheduled to span 36 months per participant ± 6 months. Before their 
first baseline visit for the annual health check at one of the four control outpatient clinics 
(Hisingen, Nordost, Väster, or Öster), patients will be screened for eligibility. If eligible, they 
will be invited to participate in the trial and join the control group during the annual health 
check. Those who agree to participate will sign written informed consent. Rescreening is 
permitted if a patient meets the exclusion criteria in one year but not in the following year, in 
which case they may be included. The clinical trial does not modify usual care, except for 
standardizing the information collected during annual health checks through the use of a 
medical history protocol (henceforth referred to as the worksheet). There are two versions of 
this worksheet: one for the intervention clinics (Appendix 1) and one for the control clinics 
(Appendix 2). While both versions include the same annual blood tests, the physical 
examination in the intervention worksheet is more extensive, as detailed in the intervention 
section and in Table 1. 
Patients who decline participation, whether from the control or intervention outpatient clinics, 
will continue to receive usual care. 
As part of usual care, the case manager prepares for the annual health check by ordering 
blood tests, beginning to fill in the worksheet, and sending a letter to the patient with 
instructions for blood sample preparation. Depending on the case, the case manager may 
send the patient self-assessment questionnaires (EQ-5D-5L, AUDIT-C, and a questionnaire 
on eating habits to be completed at home). These procedures are standard clinical routines 
and remain unchanged regardless of the patient’s participation in the clinical trial. 
Data collection procedure: 
Control clinics (Usual care) 
Baseline visits 
Visit 1 – The annual health check with the case manager 
Before this visit, patients are screened for eligibility. If eligible, they are invited to join the 
control group by a representative of the clinical trial team, and written consent is obtained 
during the annual health check. The participant is interviewed according to the control 
version of the worksheet and undergoes a somatic examination, as outlined in Table 1, 
conducted by the case manager. A blood test is ordered according to clinical practice and is 
expected to be completed before the baseline visit. The blood sample is collected following 
the standard clinical procedure used during routine annual health checks. In preparation for 
Visit 1, the case manager begins filling the worksheet for the annual health check by 
gathering information from various sources, including medical records, telephone interviews 
with the participant, or the case manager’s or physician’s prior knowledge of the patient. 

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Visit 2 – The annual health check with the physician and the case manager 
During the scheduled annual health check, the participants meet with the physician to review 
the worksheet, physical examination results, and blood test analysis. The participant, case 
manager, and physician collaborate to determine a suitable management plan based on 
clinical routines. 
Continuing Annual Health Checks 
 
Visits 3, 5, and 7 – The annual health check with the case manager 
The same routine as in Visit 1 (baseline) at the control clinics. 
Visits 4, 6, and 8 – The annual health check with the physician and case manager 
The same routine as in Visit 2 (baseline) at the control clinics. 
Intervention clinics 
The total clinical trial is scheduled to span 36 months per participant ± 6 months, during 
which case managers at outpatient clinics will maintain their routine practice of contacting 
patients for annual health checks. Before the first baseline visit to one of the two intervention 
outpatient clinics (Centrum or Mölndal), patients are screened for eligibility and, if eligible, 
are invited to join the intervention group during the annual health check, with written consent 
obtained. Rescreening is permitted if a patient meets the exclusion criteria in one year but 
not in the following year, in which case they may be included. After informed consent, the 
case manager will continue interviewing the participants and fill in the intervention version of 
the worksheet. 
The annual health checks at the intervention clinics follow the same structure of two visits as 
in routine usual care, with the primary difference being the content of the visits. 
At the annual health checks a comprehensive mapping will be conducted by the physician 
and the case manager, using a flowchart (Appendix 3) to assess the cardiometabolic health 
and lifestyle habits. The mapping process unfolds over the course of the two visits. During 
the initial visit, which lasts approximately 45 minutes, the case manager fills in the 
intervention version of the worksheet and conducts lifestyle and somatic examinations 
according to table 1 for all eligible participants. The participant then meets with the physician 
and case manager for another 45-minute session during the second visit. The physician 
assesses the cardiometabolic profile by carefully monitoring changes in various 
cardiometabolic parameters over time, using the clinically used algorithm of SCORE2 to 
provide a contextual estimate of the risk for CVD, and evaluating the fulfillment of the criteria 
for metabolic syndrome (24) as outlined in the intervention worksheet. Assessment of risk 
behavior in lifestyle habits is linked to the participant’s state of health and illness as well as 
to the gains the participants make by stopping their unhealthy lifestyle. Upon identifying 
unhealthy lifestyle habits or deviations in the cardiometabolic profile, the results are 
communicated to the participant, who receives advisory support from healthcare 
professionals. This step involves the use of motivational interview techniques and 
motivational tools to tailor individualized plans. These motivational tools include the QRISK3 
algorithm and TANITA body composition analyzer. Based on the outcomes of these 
intervention-specific steps—mapping and motivational efforts—the physician conducts a 

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medical evaluation to determine if referrals to internal resources, such as health promoters 
or physiotherapists, are needed for further assessment and support. Additionally, referrals to 
external resources, including primary health care centers, may be made for targeted 
treatments and interventions, with an emphasis on individualized care. 
The case manager has a main role to follow up and ensure that the participant has come into 
contact with the internal or external resources. This is done via regular follow-up sessions 
throughout the year. The follow-ups are estimated to take approx. 15–30 minutes. They 
consist of motivational and counseling conversations and can be conducted in-person or 
remotely. These follow-ups are individually tailored and can therefore vary in frequency, 
number, and type. Type of sessions includes the four lifestyle habits: dietary habits, physical 
activity, alcohol habits, and tobacco habits. Lifestyle changes are based on small 
adjustments, taking into account the participant’s cognitive impairments and increased 
sensitivity to stress. 
According to routine clinical practice, when the participant has established contact with either 
the internal (such as the health promoter or the physiotherapist), or external (such as the 
primary health care center) resources, the responsibility is left to those resources to follow up 
on their specific efforts during the follow-up year, which is the time between two annual 
health checks. 
However, the case manager is responsible for documenting the number of different sessions 
with the internal and external resources at the annual health checks in the worksheet the 
following year through asking the participant or checking the participants medical records. 
This will make it possible to evaluate adherence and fidelity to the intervention program. 
The participants undergo physical examinations every two months to monitor the 
development of blood pressure, pulse, waist measurement, hip measurement, weight and 
other parameters according to the body composition analyzer according to table 1. The 
intervention also includes group education sessions for participants and their relatives once a 
year. These education sessions are adapted to LAGOM’s concept and aim to deepen the 
understanding of the connection between psychotic illnesses, lifestyle habits and 
cardiometabolic health. The education sessions are physical and take 45 minutes. The 
clinical trial team will hold the education sessions. It is not necessary for a relative to be 
involved in the education sessions. If a relative is included, no data will be reported for this 
person. 
Data collection procedure: 
 
Intervention clinics 
 
Baseline visits 
 
Visit 1 – The annual health check with the case manager 
 
The same routine as in Visit 1 (baseline) for the control clinics, except for inviting to the 
intervention group and using the intervention version of the worksheet. If written consent is 
obtained, the participants are examined using a body composition analyzer by their case 
manager, as outlined in table 1. No study-specific procedures are conducted before informed 

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consent is obtained. However, in preparation for Visit 1, the case manager begins filling the 
worksheet for the annual health check by gathering information from various sources, 
including medical records, telephone interviews with the participant, or the case manager’s or 
physician’s prior knowledge of the patient. 
Visit 2 – The annual health check with the physician and the case manager 
 
During the scheduled annual health check, the participants meet with the physician to review 
the worksheet, physical examination results, and blood test analysis. The physician fills in the 
QRISK3 algorithm with the participant. The participant, case manager, and physician 
collaborate to determine individually adapted interventions based on the mapping process. 
They also agree on a follow-up plan with the case manager. 
Continuing Annual Health Checks 
 
Visits 8, 15, and 22 – The annual health check with the case manager 
 
The same routine as in Visit 1 (baseline) at the intervention clinics. 
Visits 9, 16, and 23 – The annual health check with the physician and the case manager 
 
The same routine as in Visit 2 (baseline) at the intervention clinics. 
 
Visits 3–7, 10–14, and 17–21 – Follow-up every other month with physical examination 
 
During the year following the annual health check, participants at the intervention clinics will 
attend follow-up visits every two months at the outpatient clinic for a physical examination, as 
outlined in Table 1. 
The intervention also includes an educational session for participants and their relatives once 
a year. 
 
Table 1. Data collection schedule according to worksheet 
 
Collected data 
Baseline 
Every 12 
Every 
24 
Every 36 
other 
months 
other 
months 
other 
months 
month ± 60 
month 
± 60 
month ± 60 
± 14 
days 
± 14 
days 
± 14 
days 
days 
Visits 
days 
Visits 
days 
Visits 
Visits 
8+9* 
Visits 
15+16* 
Visits 
22+23* 
3–7* 
10–14* 
17–21* 
Visits 
Visits 
Visits 
3+4 
5+6 
7+8 
Visit 1 
Visit 2# 
Check for eligibility 
X 
Informed consent 
X 
Inquire about adverse event* 
X 
X 
X 
X 
X 
X 
Social and background questions 
X 
X 
X 
X 
Medical anamnesis 
X 
X 
X 
X 
Questions about participation in 
educational sessions and lifestyle 
X 
X 
X 
X 

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sessions 
Lifestyle questionnaires 
• 
Alcohol habits according to 
AUDIT-C 
• 
Tobacco habits 
• 
Dietary habits 
• 
Physical activity 
X 
X 
X 
X 
Blood tests 
P-high-sensitivity CRP (mg/L) 
X 
X 
X 
X 
fP-Triacylglycerol (mmol/L) 
X 
X 
X 
X 
P-HDL-cholesterol (mmol/L) 
X 
X 
X 
X 
P-LDL-cholesterol (mmol/L) 
X 
X 
X 
X 
P-Total cholesterol (mmol/L) 
X 
X 
X 
X 
P-non-HDL-cholesterol (mmol/L) 
X 
X 
X 
X 
fP-Glucose (mmol/L) 
X 
X 
X 
X 
B-HbA1c (mmol/mol) 
X 
X 
X 
X 
P-Kreatinin (µmol/L) 
X 
X 
X 
X 
P-ALAT (µkat/L) 
X 
X 
X 
X 
P-ASAT (µkat/L) 
X 
X 
X 
X 
P-ALP (µkat/L) 
X 
X 
X 
X 
P-bilirubin (µmol/L) 
X 
X 
X 
X 
Physical examination 
Height (cm) 
X 
X 
X 
X 
Weight according to SECA 799 (kg) 
X 
X 
X 
X 
X 
X 
X 
Waist circumference (cm) 
X 
X 
X 
X 
X 
X 
X 
Hip circumference (cm) 
X 
X 
X 
X 
X 
X 
X 
Systolic blood pressure mmHg 
X 
X 
X 
X 
X 
X 
X 
Diastolic blood pressure mmHg 
X 
X 
X 
X 
X 
X 
X 
Pulse (bpm) 
X 
X 
X 
X 
X 
X 
X 
Assessment scales 
EQ-5D-5L 
X 
X 
X 
X 
Fulfillment of criteria of metabolic 
syndrome* 
X 
X 
X 
X 
SCORE2* 
X 
X 
X 
X 
QRISK3* 
X 
X 
X 
X 
Measurements according to TANITA body composition analyzer* 
• 
Weight (kg) 
• 
Total body fat mass (kg) 
• 
Total body water mass (kg) 
• 
Total body muscle mass (kg) 
• 
Bone mass (kg) 
• 
Metabolic age 
X 
X 
X 
X 
X 
X 
X 
* Only intervention clinics 
# Visit 2 involves no new data entry but complements Visit 1 by ensuring that all data from Visit 1 is complete. Eligibility screening and 
informed consent are always completed during Visit 1. 
 
6.6. 
End of the clinical trial 
The clinical trial ends when the last participant has completed the last visit (Visit 8 at the 
control clinics and 23 at the intervention clinics). The sponsor will notify the Swedish Medical 
Products Agency within 15 days after the end of the clinical trial and send the clinical trial 
report within 1 year after the end of the clinical trial including an easily understandable 
summary. 

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7. Quality control 
7.1. 
Monitoring 
The clinical trial will be monitored by an independent monitor before the clinical trial begins, 
during the clinical trial conduct, and after the clinical trial has been completed, so as to 
ensure that the clinical trial is carried out according to the CIP and that data is collected, 
documented, and reported according to SS-EN ISO 14155:2020 and applicable ethical and 
regulatory requirements. The monitor is appointed by the sponsor and independent in 
relation to the principal investigator and site staff. 
7.2. 
Monitoring plan 
Monitoring will be risk-based, which means the extent of the monitoring is based on the 
sponsor’s risk-assessment and is performed as per the investigation’s monitoring plan. 
Monitoring is intended to ensure that the participant’s rights, safety, and well-being are met 
as well as data in the CRF are complete, correct, and consistent with the source data. 
7.3. 
Source data 
The investigator must keep source documents for each participant in the clinical trial. A 
document describing what has been classified as source data in the clinical trial (source data 
reference document) should be included in the Investigation Site File (ISF). The investigator 
must ensure that all source documents are accessible for monitoring and other quality control 
activities. Source data is defined before clinical trial starts at each individual site and can, in 
cases where source data is not registered in another document, consist of the CRF. This 
should be decided in consultation with the monitor and clearly stated in the source data 
reference document. 
Access to investigation-related documentation, such as participants’ medical records, CRFs, 
other source data and other clinical trial documentation will be provided for monitoring and 
auditing purposes. Access to participants’ medical records will require a confidentiality 
agreement to be signed by the person in charge of the medical records at the investigational 
site and by the monitor and auditor, if applicable. Access will also be granted in the context 
of regulatory inspections. 
7.4. 
Quality assurance and quality control 
Quality assurance refers to activities that promote the collection of high-quality data, and 
quality control refers to activities that detect new data problems with sufficient time to 
implement appropriate corrective actions. Our approach to quality assurance includes: 1) 
development of a flowchart for the intervention (Appendix 3); 2) development of a medical 
history protocol (worksheet) (appendices 1 and 2); 3) train all data collectors through 
workshops; 4) regular meetings with data collectors; 5) following the manufacturer’s 
maintenance instructions of the blood pressure devices, SECA scale, and TANITA body 
composition analyzer. Our quality control strategy includes: 1) monitoring the completed 
worksheets via research nurses and research assistants; 2) in case of missing data or 
incorrect data registration in the protocols, rectify the deficiencies via research nurses during 
the first review of the protocols and research assistant before entering the data from the 
protocols into the database; 3) record data entry lag time and 4) regular meetings with 

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research nurses and research assistants to review missing data, out-of-range values, or 
illogical data relations. 
8. Statistical considerations 
8.1. 
Analytical procedures 
The clinical trial will involve longitudinal comparisons within and between the intervention 
group and the control group. The analyzes are carried out with linear regression models for 
continuous variables, logistic regressions for categorical variables, and Poisson or negative 
binomial regressions for count data (e.g., number of different sessions with the internal and 
external resources). The dependent variables in the primary analysis will be the following 
cardiometabolic risk indicators: BMI, WHR, SBP, DBP, TAG/HDL-C ratio, TChol/HDL-C ratio, 
and plasma glucose. These cardiometabolic risk indicators will be limited to those obtained 
within the visit window. The visit window is specified as 45 days before and after the second 
visit of the annual health checks (where the physician participates). Clinical trial site, age, 
and sex will be included for adjustment in the analysis model. Other covariates not balanced 
between groups will be considered for adjustment. Cardiometabolic risk indicators outside 
the visit window will be used to evaluate their impact on conclusions in a sensitivity analysis. 
To assess the impact on outliers, sensitivity analyzes will be run both with and without those 
outliers. 
For the secondary outcome, the CVD risk measured by SCORE2 will be analyzed using 
linear regression methods while CVD risk measured by the time to CVD events will be 
analyzed using survival analysis techniques such as Cox regression and Kaplan-Meier 
estimator. All statistical tests will be two-sided, using an alpha of 0.05 to control for type I 
error. 
Cost-utility analysis: To illuminate the costs in the clinical trial, we will use three different 
methods. First, through a cost description in SEK and EURO. Second, we will calculate Quality-
Adjusted Life Years (QALYs) at baseline and at 12, 24, and 36 months. (cost-indexed based on 
the clinical trial’s end date). We will compare the costs for the intervention group both with 
themselves and with the costs for the control group. Finally, we will perform an incremental cost-
effectiveness ratio (ICER), comparing the costs between the control and intervention groups at 
baseline and after 36 months. To test the model, we will also conduct a sensitivity analysis with 
a variation of +/-20%. We will not include the education cost for personnel as an additional cost 
in the analysis, nor will we consider the extra cost for managing the clinical trial (trial costs). 
However, we will consider the additional time required for the intervention in the clinical trial 
population, as well as the time it takes for regular treatment. This may result in slightly more 
frequent and sometimes longer visits for the intervention group compared with the control group, 
which needs to be studied and considered in the final calculation. Cost neutrality for direct and 
indirect costs yields a positive outcome for the clinical trial. 
8.2. 
Sample size calculation 
The estimated number of participants needed to achieve the clinical trial objectives is based 
on the expected level of clinical significance. To be clinically significant, the difference in 
mean value between the intervention and control groups should be at least: 1 kg/m2 in BMI 

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(25), 1 cm in waist circumference or 0.01 unit in WHR (26), 10 mm Hg in SBP (27), 2 mm Hg 
in DBP (28), 1 unit in TAG/HDL-C ratio (29, 30), 1 unit in TChol/HDL-C ratio (31), or 1 
mmol/L in plasma glucose (32). Table 2 shows the power calculation of the number of 
participants per group. Of the 2650 patients listed at the six psychosis outpatient clinics in 
Gothenburg, we need to recruit 157 people from the intervention clinics and 487 from the 
control clinics. 
Table 2. Power calculation for minimum number of participants per group 
 
Variable 
Standard 
deviation 
(ref.) 
Expected 
difference 
Two-tailed 
significance 
level 
Power 
% 
Expected 
dropout 
% 
Sample 
size for 
intervention 
group 
Sample 
size for 
control 
group 
WHR 
0.08 (33) 
0.03 
0.05 
80 
40 
125 
389 
BMI 
4.5 (34) 
1.5 
0.05 
80 
40 
157 
487 
SBP 
14.4 (33) 
10 
0.05 
80 
40 
37 
115 
DBP 
9 (35) 
3 
0.05 
80 
40 
157 
487 
TAG/HDL-C 
ratio 
0.9 (36) 
1 
0.05 
80 
40 
15 
47 
TChol/HDL-C 
ratio 
1.1 (36) 
1 
0.05 
80 
40 
24 
74 
Glucose 
0.8 (34) 
1 
0.05 
80 
40 
14 
42 
 
 
8.3. 
Missing data 
We have a two-step strategy to minimize the occurrence of missing data. The first step 
involves the review of completed worksheets by a research nurse after the second visit of the 
annual health check. In the second step, a research assistant signals any missing data after 
the first check. The first and second checks are performed within 45 days of the second visit 
of the annual health check. However, during summer, Christmas, and other national 
holidays, these routines may require additional time due to limited staff availability and 
scheduling constraints. 
We will analyze the following factors for the missing data: missing data levels of analysis 
(item-, construct-, and person-level) and missing data mechanism (missing completely at 
random (MCAR), missing at random (MAR) and missing not at random (MNAR)) (37). This 
analysis will guide the strategy (maximum likelihood (ML), multiple imputation (MI), listwise 
and pairwise deletion) for handling missing data. The effect that any missing data may have 
on the results as well as the robustness of the measure for handling missing data will be 
assessed through a sensitivity analysis. 
9. Data management and protection 
Participants in the clinical trial are coded with a specific record ID according to REDCap. All 
participants are registered in a participant identification list (participant enrolment and 

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identification list) that connects the participant’s name and personal number with the record 
ID. 
All data will be registered, managed, and stored in a manner that enables correct reporting, 
interpretation, and verification. 
9.1. 
Case Report Form and data cleaning 
The research nurse will organize and collect completed worksheets from the case managers and 
physicians and store them in the respective physical individual folders for the participants. 
Information is gathered using paper-based methods. Additionally, within 45 days of the second 
visit of the annual health check, the research nurse will ensure the worksheet is complete and 
accurate by addressing any missing information or questionable data. This will involve gathering 
details from various sources, such as the participant, case manager, physician, or medical 
records. All data must be finalized within 45 days of the second visit of the annual health check 
before the worksheets are handed over to the research assistant for entry into the electronic case 
report form (eCRF). At a later stage and within 45 days of the second visit of the annual health 
check, a research assistant enters all the data into the eCRF, ensuring that missing data and 
abnormal variables are identified. Examples of such abnormal variables include swapping weight 
and height values or reversing systolic and diastolic readings. Another example is indicating the 
absence of a somatic illness while also noting the use of antihypertensive or antidiabetic 
medications. All participants’ information will be considered confidential. Access to the secure 
eCRF will be encrypted, password protected and restricted to trained and authorized personnel. 
In addition, authorized personnel will have different permissions and will only be able to access 
specific areas (e.g. edit data or only read data). All data that are stored electronically will be 
encrypted and saved on a secure server housed in Region Västra Götaland using REDCap. 
9.2. 
Archiving 
The PI and sponsor will maintain the essential clinical trial documents in the investigation site 
files archive and sponsor files archive, respectively. The sponsor shall keep all 
documentation and data for at least 10 years after the clinical trial has ended. The PI will 
archive all local investigation documentation for at least 10 years or as long as stipulated by 
the local institution. 
9.3. 
Data protection 
All participants in LAGOM will receive a journal entry stating that they are participating in the 
clinical trial and what it entails. Confidentiality will be guaranteed through several 
mechanisms. For the clinical trial, each participant will be assigned a record ID. When the 
eCRF is ready for analysis, it will not contain the actual identities of the participants. When 
not in use, all study forms and paper records containing participant information will be stored 
in secure, locked areas at the respective outpatient clinic. Such material, when used, will be 
kept away from public scrutiny. In addition, access to the locked areas containing all 
participant data and information will be restricted to authorized personnel. The results will 
only be reported at the group level. The data will not be presented in such a way that the 
identity of individual participants can be deduced. 
The content of the informed consent form shall comply with relevant integrity and data 
protection legislation. In the participant information and the informed consent form, the 
participant will be given complete information about how collection, use and publication of 

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their clinical trial data will take place. The participant information and the informed consent 
form will explain how clinical trial data are stored to maintain confidentiality in accordance 
with national data legislation. 
The informed consent form will also explain that for verification of the data, authorized 
representatives of the sponsor, as well as relevant authority, may require access to parts of 
medical records or study records that are relevant to the clinical trial, including the 
participant’s medical history. 
 
10. 
Amendments to the CIP 
Amendments to the CIP will be agreed upon between the sponsor/coordinating investigator. 
Substantial modifications must be approved by the Swedish Ethical Review Authority and/or 
the Swedish Medical Products Agency before implementation. 
11. 
Deviations from the CIP 
Investigator(s) are not allowed to deviate from the CIP except if it is for the protection of the 
participant´s rights, safety, or well-being under emergency circumstances. 
All such deviations shall be documented and reported to the sponsor, the Swedish Medical 
Products Agency and/or the Swedish Ethical Review Authority (as applicable) as soon as 
possible. All deviations shall be documented with an explanation and reported to the sponsor. 
Deviations will be reviewed by the sponsor and reported to the appropriate regulatory bodies as 
required. 
12. 
Device traceability and accountability 
The TANITA body composition analyzer will be used in the clinical trial according to the 
clinical investigation plan. The TANITA body composition analyzer will be held by the clinic 
after the clinical trial. 
The TANITA body composition analyzer will be used in the clinical trial according to the 
clinical trial plan. As the TANITA body composition analyzer is a CE-marked medical device, 
we intend to use it in normal clinical practice after the clinical trial is finished. 
The TANITA body composition analyzer will be marked with a label stating “Medicinteknisk 
produkt i klinisk prövning” (Medical device in a clinical trial). It will also be entered in the 
hospital inventory system. Periodic maintenance will be performed according to 
manufacturer’s instruction stated in the IFU (instructions for use). The inventory system 
records the physical location, date of receipt and batch/serial number of the device. Marking, 
registration and periodic maintenance will be performed by the Biomedical Engineering 
Department at Sahlgrenska University Hospital. 
All medical devices used in the study will be placed in the hospital inventory system and 
periodic maintenance will be performed according to manufacturer’s instructions. 
13. 
Statements of compliance 

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13.1. 
Compliance to the investigational plan, good clinical practice, and 
regulations 
The clinical trial will be conducted in accordance with the CIP, the ethical principles of the 
Declaration of Helsinki, the principles of SS-EN ISO 14155:2020 and current national and 
international regulations governing this clinical trial. This is to ensure the safety and integrity 
of the participants as well as the quality of the data collected. The clinical trial shall not begin 
until the required regulatory and ethical assessments have been completed with non- 
negative outcomes, in accordance with Medical Device Regulation (MDR) and national 
legislation. Any additional requirements imposed by the Ethics Committee or regulatory 
authority shall be followed. 
13.2. 
Insurance 
The participants in the clinical trial will be covered by Swedish Patient Insurance 
(patientskadeförsäkring) and liability insurance (ansvarsförsäkring). 
 
14. 
Informed consent process 
14.1. 
General process for informed consent 
Before the first baseline visit at the annual health checks, patients will be screened for 
eligibility according to inclusion and exclusion criteria. If they are eligible, they will be invited 
to participate in the clinical trial during the annual health checks. 
A representative of the clinical trial team at each outpatient clinic will introduce the clinical 
trial to eligible patients and ensure that these patients receive full and adequate oral and 
written information about the clinical trial, its purpose, potential risks and benefits, and 
inclusion and exclusion criteria. The patients must also be informed that they are free to 
discontinue their participation in the clinical trial at any time without having to provide a 
reason. Patients shall be given the opportunity to ask questions and be allowed time to 
consider the information provided and participation in the clinical trial. Upon agreement the 
patient will be referred to as participant and both the participant and the representative of the 
clinical trial team shall sign the informed consent form. In connection with the information, the 
participant has the right to decline registration and is informed of the right to end his/her 
participation in the register at any time, without this affecting the treatment. A copy of the 
participant information as well as a copy of the informed consent form shall be provided to 
the participant. The participant’s signed and dated informed consent must be obtained before 
performing any activity specific to the clinical trial. The process shall be documented in the 
participant’s source documents and the signed informed consents shall be maintained with 
the essential documents. If new information becomes available that can significantly affect a 
participant’s future health and medical care, that information shall be provided to the affected 
participant(s) in written form. If new information is added to the clinical trial, the participant 
has the right to reconsider whether he/she will continue their participation. 
15. 
Adverse events, adverse device effects and device 
deficiencies 

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15.1. 
Definitions 
Adverse Event 
An Adverse Event (AE) is untoward medical occurrence, unintended disease or injury or any 
untoward clinical signs, including an abnormal laboratory finding, in participants, users or 
other persons, in the context of a clinical trial, whether or not related to the investigational 
device. 
This definition includes events that are anticipated as well as unanticipated events 
This definition includes events occurring in the context of a clinical trial related to the 
investigational device or the procedures involved. 
Adverse Device Effect 
An Adverse Device Effect (ADE) is any AE related to the use of an investigational medical 
device. 
This definition includes adverse events resulting from insufficient or inadequate instructions 
for use, deployment, implantation, installation, or operation, or any malfunction of the 
investigational medical device. 
This definition includes any event resulting from use error or from intentional misuse of the 
investigational medical device. 
Serious Adverse Event 
A Serious Adverse Event (SAE) is any AE that led to any of the following: 
a) death, 
b) serious deterioration in the health of the participant, that resulted in any of the following: 
i. life-threatening illness or injury, 
ii. permanent impairment of a body structure or a body function, 
iii. hospitalization or prolongation of patient hospitalization, 
iv. medical or surgical intervention to prevent life-threatening illness or 
injury or permanent impairment to a body structure or a body function, 
v. chronic disease, 
c) fetal distress, fetal death or a congenital physical or mental impairment or birth defect 
Serious Adverse Device Effect 
A Serious Adverse Device Effect (SADE) is an ADE that has resulted in any of the 
consequences characteristic of a serious adverse event. 
SAEs related to procedures imposed by the clinical trial plan but not with the use of the 
device shall not be considered Serious Adverse Device Effects. 
 
Unanticipated Serious Adverse Device Effect 
An Unanticipated SADE is an effect which by its nature, incidence, severity or outcome has 
not been identified in the current risk assessment. Procedures associated with the use of a 

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device shall be addressed in the risk assessment, which makes it possible to determine 
whether the procedure related SAEs are Unanticipated Serious Adverse Device Effect or not. 
SAEs related to procedures imposed by the CIP but not with the use of the device shall not 
be considered Serious Adverse Device Effects. 
Device Deficiency 
A Device Deficiency (DD) is any inadequacy in the identity, quality, durability, reliability, 
safety or performance of an investigational device, including malfunction, use errors or 
inadequacy in information supplied by the manufacturer. 
15.2. 
Recording and Reporting 
Recording 
The principal investigator or an authorized designee will record: 
• 
all AEs except the following events specified not to be recorded; The symptoms and 
signs that are clearly related to psychotic disorders and the expected course of the 
condition and to the adverse effects of medications used. In addition, AEs will not be 
followed or recorded at the control clinicssince these participants will not be exposed 
to any of the devices. 
• 
all SAEs 
• 
all DDs 
• 
any new finding in relation to any of the above-mentioned events. 
Reporting 
The investigators will report all SAEs and DDs to the sponsor, immediately but not later than 
3 calendar days after investigation site study personnel’s awareness of the event. 
The sponsor will report to the Swedish Medical Products Agency all of the following 
reportable events: 
• 
any SAE that has a causal relationship with the investigational device or the 
investigation procedure, or where such causal relationship is reasonably possible; 
• 
any DD that might have led to a SAE if appropriate action had not been taken, 
intervention had not occurred, or circumstances had been less fortunate; and 
• 
any new findings in relation to any event referred to above. 
Reporting by the sponsor will be done by filling out the “Summary Reporting Form” (MDCG 
2020-10/2). The form will be filled in/updated for each reportable event or for new 
findings/updates to already reported events. The form will be transmitted to the Swedish 
Medical Products Agency. For events that indicate an imminent risk of death, serious injury, 
or serious illness and that requires prompt remedial action for other patients/participants, 
users or other persons or a new finding to it will be reported immediately, but not later than 2 
calendar days after awareness by sponsor of a new reportable event or of new information in 
relation with an already reported event. Any other reportable events or a new finding/update 
to it will be reported immediately, but not later than 7 calendar days following the date of 
awareness by the sponsor of the new reportable event or of new information in relation with 
an already reported event. 

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Assessment of Causality 
The relationship between each adverse event and the investigational device and the 
investigation procedure will be assessed and recorded by the investigator and sponsor. For 
assessment of causality, the IB and the risk analysis report will be consulted. The sponsor 
and investigator will distinguish between SAEs related to the investigational device and those 
related to the procedures, relatedness to both is possible. 
Each SAE will be classified according to four different levels of causality: 
1. Not related 
Relationship to the device or procedures can be excluded when: 
− the event has no temporal relationship with the use of the investigational device, or 
the procedures related to application of the investigational device; 
− the SAE does not follow a known response pattern to the medical device (if the 
response pattern is previously known) and is biologically implausible; 
− the discontinuation of medical device application or the reduction of the level of 
activation/exposure - when clinically feasible - and reintroduction of its use (or 
increase of the level of activation/exposure), do not impact on the serious adverse 
event; 
− the event involves a body-site or an organ that cannot be affected by the device or 
procedure; 
− the SAE can be attributed to another cause (e.g. an underlying or concurrent illness/ 
clinical condition, an effect of another device, drug, treatment or other risk factors); 
− the event does not depend on a false result given by the investigational device 
used for diagnosis, when applicable; 
In order to establish the non-relatedness, not all the criteria listed above might be met 
at the same time, depending on the type of device/procedures and the SAE. 
2. Possible 
The relationship with the use of the investigational device or the relationship with 
procedures, is weak but cannot be ruled out completely. Alternative causes are also 
possible (e.g. an underlying or concurrent illness/ clinical condition or/and an effect of 
another device, drug or treatment). Cases where relatedness cannot be assessed, or 
no information has been obtained shall also be classified as possible. 
3. Probable 
The relationship with the use of the investigational device or the relationship with 
procedures, seems relevant and/or the event cannot be reasonably explained by 
another cause. 
4. Causal relationship 
The SAE is associated with the investigational device or with procedures beyond 
reasonable doubt when: 
− the event is a known side effect of the product category the device belongs to or of 
similar devices and procedures; 
− the event has a temporal relationship with investigational device use/application or 
procedures; 
− the event involves a body-site or organ that 
o the investigational device or procedures are applied to; 
o the investigational device or procedures have an effect on; 

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− the serious adverse event follows a known response pattern to the medical device 
(if the response pattern is previously known); 
− the discontinuation of medical device application (or reduction of the level of 
activation/exposure) and reintroduction of its use (or increase of the level of 
activation/exposure), impact on the SAE (when clinically feasible); 
− other possible causes (e.g. an underlying or concurrent illness/ clinical condition 
or/and an effect of another device, drug or treatment) have been adequately ruled 
out; 
− harm to the participant is due to error in use; 
− the event depends on a false result given by the investigational device used for 
diagnosis, when applicable; 
 
In order to establish the relatedness, not all the criteria listed above might be met at the 
same time, depending on the type of device/procedures and the SAE. 
16. 
Premature termination of the clinical trial 
The sponsor may suspend or prematurely terminate either the clinical trial at an individual 
clinical trial site or the entire clinical trial for significant and documented reasons. The 
Swedish Medical Products Agency may suspend or prematurely terminate the clinical trial at 
the applicable clinical trial sites. 
If suspicion of an unacceptable risk to participants arises during the clinical trial, or when so 
instructed by the Medical Products Agency, the sponsor will suspend the clinical trial while 
the risk is assessed. The sponsor will terminate the clinical trial if an unacceptable risk is 
confirmed. The sponsor will inform all investigators. 
The sponsor shall consider terminating or suspending the participation of a particular clinical 
trial site or investigator in the clinical trial if monitoring or auditing identifies serious or 
repeated deviations on the part of an investigator. If the suspension or premature termination 
was in the interest of safety, the sponsor shall inform all other principal investigators. 
If, in the opinion of the investigator, the clinical observations in the clinical trial suggest that it 
may be unsafe to continue the clinical trial at the site, the investigator may terminate 
participation in the investigation after consultation with the sponsor. A written statement fully 
documenting the reasons for such termination will be provided to the sponsor. If the clinical 
trial is prematurely terminated, the investigators shall promptly inform the participants and 
take necessary steps to finalize their engagement in the clinical trial. All relevant investigation 
material must be collected, and accountability completed. 
If the clinical trial is interrupted or terminated prematurely the sponsor will report to the 
Medical Products Agency within 15 days together with a justification. If the sponsor has 
temporarily halted or prematurely terminated the clinical trial on safety grounds, the Medical 
Products Agency will be informed within 24 hours. A clinical trial report will be prepared within 
three months of the early termination or temporary halt, irrespective of the results. In the 
event that the clinical trial is restarted within three months of the temporary halt, the sponsor 
does not have to submit a clinical trial report until the clinical trial has been completed. 

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The final clinical trial report shall include details with respect to the temporary halt. 
17. 
Publication policy 
 
The clinical trial will be registered in a publicly accessible database before the start of 
recruitment activities and the content will be updated throughout the conduct of the clinical 
trial and the results entered at completion of the clinical trial. The results will be submitted for 
publication in scientific journals. The first results are expected to be available in 2027. 
Results will also be disseminated through, for example, national and international 
conferences, meetings at the relevant county councils, or in the media. 
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19. 
Appendix 
 
Appendix 
File name 
Medical history protocol (Intervention clinics) 
Appendix_bilaga 1_LAGOM 
Medical history protocol (Control clinics) 
Appendix_bilaga 2_LAGOM 
Flowchart 
Appendix_bilaga 3_LAGOM