A Randomized Open-label Parallel-group Trial is to Analyze the Efficacy and the Efficiency of the Social-Local-Mobile (So-Lo-Mo) Intervention Applied to the Smoking Cessation Process.
Phase: NA
Conditions: Smoking Cessation, Health Behavior, Lifestyle-related Condition
Sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

COVER PAGE 
 
A Randomized Open-label Parallel-
group Trial to Analyze the Efficacy and 
the Efficiency of the Social-Local-
Mobile (So-Lo-Mo) Intervention 
Applied to the Smoking Cessation 
Process 
 
 
 
 
 
 
 
Date: 15th July 2016 
 
 

So-Lo-Mo Pilot: Clinical Trial Protocol 
 
Table of contents 
 
1. Clinical Trial Protocol Agreement Form ................................................................................. 4 
2. List of abbreviations ............................................................................................................. 5 
3. Contact information ............................................................................................................. 6 
4. Protocol synopsis ................................................................................................................. 8 
5. Summary of study design and rationale ................................................................................. 11 
5.1. Introduction ................................................................................................................ 11 
5.2 Summary of Study Design ............................................................................................. 12 
5.2.1 Profile of Study Drugs ............................................................................................ 12 
5.3 Potential risks and benefits............................................................................................. 12 
5.4 Study Rationale ............................................................................................................ 13 
6. Study objectives and endpoints ............................................................................................ 15 
6.1 Study Objectives .......................................................................................................... 15 
6.1.1 Primary Objective................................................................................................... 15 
6.1.2 Secondary Objectives .............................................................................................. 15 
6.2. Study outcomes ........................................................................................................... 15 
6.2.1 Parameters of efficacy ............................................................................................. 15 
6.2.2 Parameters of efficiency .......................................................................................... 15 
6.2.3 Parameters of safety ................................................................................................ 16 
7. Subject Selection and Withdrawal criteria ............................................................................. 17 
7.1   Population base .......................................................................................................... 17 
7.2   Recruitment ............................................................................................................... 18 
7.3   Inclusion criteria ......................................................................................................... 18 
7.4   Exclusion criteria ........................................................................................................ 18 
7.5   Discontinuation and Withdrawal of subjects the Study .................................................... 19 
8. Clinical trial protocol .......................................................................................................... 20 
8.1 Study Procedures .......................................................................................................... 20 
8.1.1 Collected variables ................................................................................................. 20 
8.1.2 Follow-up .............................................................................................................. 21 
8.2 Duration of study participation ....................................................................................... 22 
9. Trial medication................................................................................................................. 23 

9.1 Treatment plan ............................................................................................................. 23 
9.1.1 Bupropion therapy .................................................................................................. 23 
9.1.2 Varenicline therapy ................................................................................................. 23 
9.2   Treatment Assignment procedures ................................................................................ 24 
9.2.1 Randomization ....................................................................................................... 24 
10. Safety monitoring ............................................................................................................. 25 
10.1 Adverse Events (AE) ................................................................................................... 25 
10.1.1 Definition ............................................................................................................ 25 
10.1.2 Adverse events of the different treatments ............................................................... 25 
11. Statistical considerations and analytical plan ....................................................................... 26 
11.1 Responsibility for analysis ........................................................................................... 26 
11.2 Justification of sample size ........................................................................................... 26 
11.3 Data analysis .............................................................................................................. 26 
12. References ...................................................................................................................... 27 
13. Appendices...................................................................................................................... 29 
Appendix 1. Smoker form ................................................................................................... 29 
Appendix 2. Fagerström test ................................................................................................ 35 
Appendix 3. Richmond test ................................................................................................. 37 
Appendix 4. EuroQol-5D .................................................................................................... 38 
Appendix 5. SF-36 ............................................................................................................. 41 
Appendix 6. IPAQ-27 ......................................................................................................... 47 
 
 
 
 
 

 
1. Clinical Trial Protocol Agreement Form 
 
 
 

2. List of abbreviations 
 
SAS Servicio Andaluz de Salud (Andalusian Health Service) 
So-Lo-Mo Social-Local-Mobile 
ICER Incremental Cost-Effectiveness Ratio 
QALY Quality-Adjusted Life Year 
COPD Chronic Obstructive Pulmonary Disease 
R&D Research & Development 
NRT Nicotine Replacement Therapy 
MAOI Monoamine Oxidase Inhibitor 
WHO World Health Organization 
IARC Agency for Research on Cancer 
SIDS Sudden Infant Death Syndrome 
ICT Information and Communication Technologies 
SMS Short Message Service 
EMA European Medication Agency 
APP Mobile Application 
CO Carbon Monoxide 
DoA Document of Agreement 
AE Adverse Event 
 
 
 
 
 
 
 

3. Contact information 
 
Clinical Principal Chief 
Investigator 
Francisco Ortega Ruiz, PhD 
COPD and Respiratory Rehabilitation Department 
Medical-Surgical Unit of Respiratory Diseases 
Virgen del Rocío University Hospital 
Edificio de Laboratorio, 1ª Planta 
Sevilla 41013, Spain 
Tel: +34 955 313163 
Fax: 
Email: francisco.ortega.sspa@juntadeandalucia.es 
Clinical Co-Investigator 
Laura Carrasco Hernández 
COPD and Respiratory Rehabilitation Department 
Medical-Surgical Unit of Respiratory Diseases 
Virgen del Rocío University Hospital 
Edificio de Laboratorio, 1ª Planta 
Sevilla 41013, Spain 
Tel: +34 955013164 
Fax: 
Email: sakuraalo@hotmail.com 
Psychologist 
Marco Mesa González 
COPD and Respiratory Rehabilitation Department 
Medical-Surgical Unit of Respiratory Diseases 
Virgen del Rocío University Hospital 
Edificio de Laboratorio, 1ª Planta 
Sevilla 41013, Spain 
Tel: +34 955013164 
Fax: 
Email: mesagonza@gmail.com 
Academic Principal 
Investigator 
Carlos Luis Parra Calderón 
Health Informatics R&D Group 
Centro de Documentación Clínica 
Virgen del Rocío University Hospital 
Sevilla 41013, Spain 
Tel: +34 955 01 36 62 
Fax: +34 955 013310 
Email:carlos.parra.sspa@juntadeandalucia.es 
Academic Co-Investigator 
Francisco J. Núñez Benjumea, MSc 
Health Informatics R&D Group 
Centro de Documentación Clínica 
Virgen del Rocío University Hospital 
Sevilla 41013, Spain 
Tel: +34 955 01 36 16 
Fax: +34 955 013310 
Email: francisco.nunez.exts@juntadeandalucia.es 
Academic Co-Investigator 
Francisco Jódar Sánchez, MSc, PhD 
Health Informatics R&D Group 
Centro de Documentación Clínica 

Virgen del Rocío University Hospital 
Sevilla 41013, Spain 
Tel: +34 955 01 36 17 
Fax: +34 955 013310 
Email: francisco.jodar.exts@juntadeandalucia.es 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

4. Protocol synopsis 
 
Title 
A randomized open-label parallel-group trial is to analyze the efficacy 
and the efficiency of the Social-Local-Mobile (So-Lo-Mo) 
intervention applied to the smoking cessation process. 
Sponsor 
Virgen del Rocío University Hospital and European Commission. 
Principal Investigator 
Trial Location 
Francisco Ortega Ruiz, PhD 
COPD and Respiratory Rehabilitation Department 
Medical-Surgical Unit of Respiratory Diseases 
Virgen del Rocío University Hospital 
Edificio de Laboratorio, 1ª Planta 
Sevilla 41013, Spain 
Project Phase 
Pilot study. 
Indication 
Interventional/treatment. 
Primary study objectives 
To analyze the efficacy and efficiency of the So-Lo-Mo intervention 
applied to the smoking cessation process compared to usual care. 
Secondary study objectives 
● 
To monitor usual psycho-pharmacological therapies (bupropion, 
varenicline and behavioural therapy). 
● 
To monitor healthy lifestyle and physical exercise habits.  
Study design 
A randomized open-label parallel-group trial. 
Population 
Smoking population attending to the Smoking Cessation Unit of 
Virgen del Rocío University Hospital. 
Sample size 
240 patients: 120 patients in the intervention group (So-Lo-Mo 
intervention) and 120 patients in the control group (usual care). 
Inclusion criteria 
● 
Smoking population attending to the Smoking Cessation Unit of 
Virgen del Rocío University Hospital. 
● 
Subjects >18 years old who want to give up smoking. 
● 
Android-based smartphone availability. 
● 
Ability to interact with the smartphone.  
● 
To sign an Informed Consent Form. 
Exclusion criteria 
● 
Subjects had some previous adverse effects related to the 
pharmacological treatment included in the study. 
Intervention 
The So-Lo-Mo intervention will monitor usual psycho-
pharmacological therapy (bupropion + behavioral therapy, varenicline 
+ behavioral therapy), healthy lifestyle and physical exercise. 
Concurrent controls 
Usual intervention consists of pharmacological therapy (bupropion or 
varenicline) and behavioural therapy.  
Parameters of efficacy 
The main clinical outcome will be the smoking abstinence rate at 1 
year measured by means of exhaled CO and urinary cotinine tests as 
detailed in the appendix A.  

Parameters of efficiency 
The result of economic evaluation will be expressed in terms of 
incremental cost-effectiveness ratio (ICER).  
Parameters of safety 
Adverse events related with pharmacological therapies. 
Assessment schedule 
The follow-up will be carried out according to the following schedule: 
● 
Basal consultation: The patient is assessed for the first time in the 
Smoking Cessation Unit as he/she is referred from either 
Pneumology Unit or another clinical department. All the 
information fields included in the appendix A will be collected. 
● 
2nd consultation: 15 (± 5) days after the basal consultation. 
Information regarding the following sections will be collected: 
smoking related symptoms, treatment adherence, daily cigarettes, 
possible adverse events, exhaled CO, cotinine test, clinical 
information. Relaxation techniques and risk avoiding techniques 
are also explained to the subject. 
● 
3rd consultation: 30 (± 5) days after the basal consultation. 
Information regarding the following sections will be collected: 
smoking related symptoms, treatment adherence, possible adverse 
events, exhaled CO, cotinine test, clinical information. New 
relaxation techniques are explained in case the former resulted 
useless. Coaching for relapse prevention is performed. 
● 
4th consultation: 60 (± 5) days after the basal consultation. 
Information regarding the following sections will be collected: 
smoking related symptoms, treatment adherence, and possible 
adverse events. Risk avoiding techniques are reinforced. 
● 
5th consultation: 90 (± 5) days after the basal consultation. 
Information regarding the following sections will be collected: 
physical and psychological health state, exhaled CO, cotinine test, 
and clinical information. 
● 
6th consultation: 120 (± 5) days after the basal consultation. The 
patient could be assessed by phone in case he/she has completed 
the pharmacological treatment. Information regarding symptoms 
related to abstinence will be collected in this session. Coaching 
for relapse prevention is performed and confronting techniques 
are explained to the subject. 
● 
7th consultation: 180 (± 5) days after the basal consultation. 
Information regarding the following sections will be collected: 
exhaled CO, cotinine test, clinical information, quality of life 
(EuroQoL 5D questionnaire) and physical activity monitoring 
(IPAQ-27 questionnaire). Relaxation and confronting techniques 
are reinforced when needed. 
● 
8th consultation: 365 (± 5) days after the basal consultation. 
Information regarding the following sections will be collected: 
exhaled CO, cotinine test, blood pressure, weight, height, quality 
of life (EuroQoL 5D and SF-36 questionnaires) and physical 
activity monitoring (IPAQ-27 questionnaire).  
Data analysis 
A descriptive analysis of patients’ characteristics by absolute and 
relative frequencies for qualitative variables and average +/- standard 
deviation for quantitative variables will be carried out at the end of the 
study. 
Furthermore, a bivariate analysis of study groups will be performed 
for qualitative variables by chi-square test or Fisher's exact test. 

Comparison of quantitative variables will be different depending on 
technical assumptions parametric (Student t-test or ANOVA) or 
nonparametric (Mann-Whitney U-or Kruskal-Wallis). 
Duration of study period 
(per subject) 
The assessment and follow-up of the patients included in the study 
will be carried out during 12 months. 
 
 
 

5. Summary of study design and rationale 
5.1. Introduction 
Smoking is currently considered as a chronic-addictive and recidivist illness. Tobacco consumption is 
the main cause of death that might be prevented in the western side of the world; it is also the cause of 
premature death as to 50% out of the population who smoke regularly basically due to respiratory, 
cardiovascular problems and various neoplasms [1]. 
 
According to World Health Organization (WHO) one third of the world adult population today, 1.1 
billion people are smokers and 3.5 million deaths per year are attributed to smoking. It is estimated 
that in 2020 the number of deaths per year will be increased to 10 million. Smokers are 13 times more 
likely to die from COPD than nonsmokers [2]. The main smoking attributable effects on the 
respiratory system are: 
● Cancer of the trachea, bronchus and lung [1, 2]. 70%-90% deaths from lung cancer are due to 
smoking (since 4000 chemical compounds are contained in a cigarette that have been listed by 
the International Agency for Research on Cancer (IARC) as directly associated with cancer in 
humans (“class A” carcinogens). 
● Chronic obstructive pulmonary disease (Chronic bronchitis and emphysema) [2, 3]. Smoking 
is the main cause of 80-85% of COPD. 
● Lung infections (pneumonia, influenza) are increased. 
● Exacerbation of asthma [2, 3]. 
● Pulmonary fibrosis 
● Triggering autoimmune disease. 
● Pregnant women and effects on the fetus (mainly sudden infant death syndrome a.k.a. SIDS 
or crib death, and a 60% increase of the mortality rate) 
  
Tobacco consumption is highly influenced by socioeconomic factors, affecting mostly low- and 
middle-income countries as well as vulnerable populations within high income countries. 
Additionally, smoking causes health inequality between gender and age groups while it significantly 
elevates the preventable morbidity and premature mortality worldwide [4]. 
 
Frequently and erroneously, it is considered that smoking is a personal option exclusively. This 
statement seems not to be true since the vast majority of smoking people claim that they would wish 
to stop the tobacco consumption when they are deeply aware of all the negative side effects in their 
health, yet they find it difficult to cope with their desire of stop smoking due to the great addictive 
engagement to nicotine. Fortunately there are a variety of useful treatments to help them to achieve 

their goal, like bupropion, varenicline and nicotine replacement therapy, which are currently 
prescribed to those patients attending the Smoke Cessation Unit at Virgen del Rocío University 
Hospital and wish to quit smoking. 
 
Recent research on the beneficial effect that physical exercise and the feedback through Social 
Networks from people that successfully completed the smoking cessation process has on people who 
is currently undergoing this process has shown its usefulness with a moderate level of evidence [5, 6]. 
Therefore an intervention based on adherence to physical activity with ICT support (App 
Gamification, Facebook and SMS) may provide a valuable aid in smoking cessation [7]. In addition, 
craving is one key component that has been shown to vary over time during a smoking-cessation 
attempt and be highly related to treatment efficacy and cessation success [8]. It is well documented 
though that craving fades away during the first 2 weeks of abstinence. However, craving may return 
given that smokers although initially able to cope with negative affect using limited alternate coping 
strategies, over time such strategies lose their effectiveness, leaving smokers with less and less ability 
to resist the urge to smoke. 
5.2 Summary of Study Design 
This is a randomized open-label parallel-group trial. We will recruit up to 240 patients during 8 
months and a 12 months follow-up will be carried out for each one of the recruited patients. The 
sample will split in two groups: control group (n=120) who will receive usual psycho-
pharmacological therapy and the intervention group (n=120) who will receive usual therapy plus So-
Lo-Mo app. 
5.2.1 Profile of Study Drugs 
● Zyntabac® (Bupropion) 150 mg, manufactured by Glaxosmithkline lab 
● Champix® (Varenicline) 0.5 mg or 1 mg, manufactured by Pfizer lab. 
● So-Lo-Mo app is an Android-based mobile application that is being designed and developed 
by University of Seville and SaluMedia, SL. 
5.3 Potential risks and benefits 
It is envisaged the use one drug in this intervention. This drug is safe; however clinical researchers 
should prescribe it with caution and taking into account its related potential adverse effects and 
contraindications.  
 
Bupropion, though safe, is the drug with more contraindications that will be prescribed during the So-
Lo-Mo study. This drug should be prescribed carefully to subjects with liver failure, kidney failure 

and/or elder patients. It is contraindicated in the following scenarios: mental disease, central nervous 
system tumor, liver cirrhosis, and/or patients already prescribed with Monoamine Oxidase Inhibitors 
(MAOIs). Further information from the Spanish Medicine Agency can be found on this link. 
 
Varenicline is a very safe drug, which can be prescribed to elders with liver failure. The dose should 
be adjusted in the presence of kidney failure. Further information from the EMA can be found on this 
link. 
 
5.4 Study Rationale 
Nowadays, the treatment usually prescribed to patients who wish to give up smoking is a 
multidisciplinary intervention, combining both psychological advice and drug therapy, since the 
application of both strategies significantly increases the chance of success in a quit attempt.  
 
Psychological interventions can be performed at different levels depending on resources availability 
and the level of care, without difference in efficacy between individual and group therapies. 
Interventions through telephone and internet have also shown to be effective [9, 10]. 
 
In this scenario, psychological treatments are based on confronting techniques including behavioral 
and cognitive-behavioral therapies. Behavioral therapies are designed to help smokers to recognize 
and avoid external stimuli temporarily associated with the consumption of tobacco, while cognitive-
behavioral therapies provide the tools to confront both physiological and cognitive stimuli with the 
urge to smoke. 
 
During the smoking cessation process, patients usually rely on the pharmacological treatment too. 
There is a wide range of drugs that could support this process, and the physicians in the Smoking 
Cessation Unit at Virgen del Rocío University Hospital usually prescribe either bupropion or 
varenicline. Their efficacy differs according to the following rates when compared to a placebo 
cohort: Bupropion doubles the abstinence rate related to placebo, although its efficacy is lower than 
varenicline. However, the most effective drug in the smoking cessation process is varenicline, which 
triples the efficacy compared to placebo, improving bupropion performance [11]. In this sense, we 
will compare the effectiveness of usual pharmacological treatment prescribed (varenicline or 
bupropion) plus behavioral and cognitive-behavioral therapies routinely delivered at VRUH when 
added to the So-Lo-Mo intervention. Should the addition of the So-Lo-Mo intervention prove any 
meaningful increase in the smoke cessation treatment effectiveness rate, it could therefore be inferred 

that this increment will also take place when added to nicotine replacement therapy, given that 
varenicline and bupropion are currently more effective than it. 
 
Nowadays, social networks influence our daily lives and, therefore, may influence our smoking 
habits. This could be then used as an extra aid to quit smoking. For instance, an intervention based on 
adherence to physical activity with ICT support (App Gamification, Facebook and SMS) may provide 
a valuable aid in smoking cessation [7]. 
 
In addition, craving is one key component that has been shown to vary over time during a smoking 
cessation attempt and is highly related to treatment efficacy and cessation success [8]. It is well 
documented though that craving decreases during the first 2 weeks of a quit attempt. However, it may 
be that smokers are initially able to cope with negative affect using limited alternate coping strategies, 
but over time, the ability to use such strategies, or the effectiveness of such strategies, may diminish, 
leaving smokers with less and less ability to resist the urge to smoke. 
 
The word for the first quarter of our century is hyper-connection. In this hyper-connected world two 
main actors are the degree of penetration of the mobile technologies and the social networks. 
Understanding the way social networks and mobile technologies can influence individual behavior 
and the decision to smoke or not, is essential to optimize their utilization as a means of prevention and 
treatment in the future. 
 
Additionally, and on the basis of previous studies of members of our consortium, we hypothesize that 
an increase in adherence to physical activity in a 20% can increase the number of people who quit 
smoking in a 25%. 
 
The objective of the So-Lo-Mo intervention would be twofold. First of all the So-Lo-Mo intervention 
will focus on distracting the user by delivering a number of tasks through a mobile app. Taking into 
consideration the understanding of craving during smoking cessation attempts and based on the user’s 
profile, So-Lo-Mo will ask the user to undertake some short-term or long-term tasks.  
 
 
 

6. Study objectives and endpoints 
The main clinical outcome of the So-Lo-Mo intervention will be the smoking abstinence rate at 1 year 
measured by means of exhaled carbon monoxide and urinary cotinine tests. It is expected that So-Lo-
Mo intervention will increase this rate approximately 10% in the intervention group (So-Lo-Mo plus 
routine therapies) compared to control group (routine therapies). 
6.1 Study Objectives 
6.1.1 Primary Objective 
● The main objective is to analyze the efficacy and the efficiency of the So-Lo-Mo intervention 
applied to the smoking cessation process. 
6.1.2 Secondary Objectives 
● Monitoring of the routine psycho-pharmacological therapy (varenicline + behavioral therapy 
and bupropion + behavioral therapy). 
● Monitoring of healthy lifestyle and physical exercise.  
6.2. Study outcomes 
6.2.1 Parameters of efficacy 
The main clinical outcome will be the smoking abstinence rate at 1 year measured by means of 
exhaled CO and urinary cotinine tests. Patients with cotinine concentrations over 200 ng/ml will be 
considered as smokers. 
6.2.2 Parameters of efficiency 
Results of the economic evaluation (efficiency analysis) will be expressed in terms of the ICER, 
calculated by dividing the difference in total costs between the intervention group (So-Lo-Mo) and the 
control group by the difference in quality-adjusted life year (QALY) between both groups. 
 
In order to estimate the costs associated to control and intervention groups, healthcare resources 
utilization will be measured in terms of specialist (including psychologist) consultations carried out 
off the protocol related to the smoking cessation process. Costs of pharmacological treatment will also 
be taken into account. In addition, the time employed by healthcare professionals during the So-Lo-
Mo intervention will also be taken into account when estimating the costs of the So-Lo-Mo 
intervention. 
 

Benefit for patients will be expressed in terms of QALYs. QALY is a variable that expresses both the 
quality and the quantity of life. EuroQol-5D-5L questionnaire will be used to estimate QALYs. 
6.2.3 Parameters of safety 
Safety will be measured as the number of adverse events related with pharmacological therapies. The 
following adverse events have been identified related to each pharmacological therapy: 
● Varenicline: 
○ Nausea, vomit. 
○ Headache. 
○ Insomnia, abnormal dreams. 
○ Constipation, flatulence 
● Bupropion: 
○ Insomnia. 
○ Headache. 
○ Dryness in the mouth. Alteration of taste. 
○ Skin reactions. 
○ Convulsions, cardiovascular side effects and severe skin reactions. 
 
 
 

7. Subject Selection and Withdrawal criteria 
7.1   Population base 
The So-Lo-Mo pilot is configured as a 12-month randomized open-label parallel-group trial to 
determine the impact of the intervention in smoking population attending to the Smoking Cessation 
Unit at the Virgen del Rocío University Hospital in Seville. It is expected that most of the subjects 
recruited will be patients referred from different clinical departments of the Hospital (e.g. Digestive, 
Hematology, Pneumology, etc) and from primary care. 
 
Control group (N = 120) 
 
Control intervention consists of pharmacological and plus behavioral therapy, as well as advices about 
exercise and healthy lifestyle habits. Taking into account that the Smoking Cessation Unit usually 
prescribes two pharmacological therapies, patients randomly assigned to the control group will be 
randomized again into 2 subgroups: 
1. Behavioral therapy + bupropion (N = 60) 
2. Behavioral therapy + varenicline (N = 60) 
 
Intervention group (n=120) 
 
The So-Lo-Mo intervention will monitor usual psycho-pharmacological therapy, advices about 
exercise and healthy lifestyle habits added to the use of the So-Lo-Mo App as part of the treatment. 
Taking into account that the Smoking Cessation Unit usually prescribes two pharmacological 
therapies, patients randomly assigned to the control group will be randomized again into 2 subgroups: 
3. Behavioral therapy + bupropion + So-Lo-Mo (N = 60) 
4. Behavioral therapy + varenicline + So-Lo-Mo (N = 60) 
 
 
So-Lo-Mo intervention group  (N=120) 
Control group (N=120) 
Behavioral therapy + bupropion + So-Lo-Mo 
(N = 60) 
Behavioral therapy + varenicline + So-Lo-Mo 
(N = 60) 
Behavioral therapy + bupropion (N = 60) 
Behavioral therapy + varenicline (N = 60) 
 
Table 1. Sample distribution between intervention and control groups. 

7.2   Recruitment 
All participants will sign an Informed Consent Form and Information Sheet in language and terms that 
they understand. It will follow the guidelines stated at the part A of the corresponding DoA and will 
inform the participants regarding their rights: 
● To know that participation is voluntary. 
● To ask questions and receive understandable answers before making a decision. 
● To know the degree of risk and burden involved in participation. 
● To know who will benefit from participation. 
● To receive assurances that appropriate insurance cover is in place. 
● To know how their data will be collected, protected during the project and either destroyed or 
reused at the end of the research, if plan to reuse the data exist. 
● To know that anonymized data may be shared within the consortium during the project. 
● To be duly informed, and consent also for this further usage. 
● To withdraw themselves and their data from the project at any time without any kind of 
negative consequence and/or penalty in their usual care. 
 
The copy of the provided permission must explicitly mention that such information has been provided 
to the committee prior to any authorization being delivered and thus taken into consideration by the 
latter. All the personal information will be anonymized. 
7.3   Inclusion criteria 
● Smoking population attending to the Smoking Cessation Unit of Virgen del Rocío University 
Hospital. 
● Subjects >18 years old who want to give up smoking. 
● Android-based smartphone availability. 
● Ability to interact with the smartphone. The subject will be considered suitable for 
recruitment if he/she (or his/her usual caregiver) is able to open an App and interact with it. 
Example: The subject (or his/her usual caregiver) is able to send an e-mail or SMS through 
his/her smartphone. 
● To sign an Informed Consent Form. 
7.4   Exclusion criteria 
● Subjects had reported some previous adverse effects with the treatment that will be given. 

7.5   Discontinuation and Withdrawal of subjects the Study 
● Subjects voluntarily interrupting the treatment. 
● Subjects interrupting the treatment due to adverse effects. 
● Subjects changing initial treatment. 
● Subjects having some adverse effects. 
● Subjects leaving the follow up. 
 
 
 

8. Clinical trial protocol 
8.1 Study Procedures 
The total patient sample to be included in the trial is 240. Half (120) of them will take part in the 
intervention group (So-Lo-Mo intervention). The other (120) patients will act as the control group 
undergoing the usual care. 
8.1.1 Collected variables 
Information from all patients undergoing this trial will be gathered according to the following 
domains. An exhaustive description of the clinical variables that will be collected can be found in the 
Appendix 1 of this document. 
● Demographic data. 
● Socio-economic data. 
● Relevant clinical data: Diseases, treatment, co-morbidities, weight, blood pressure, etc. 
● Nicotine dependence (Fagerström test). See Appendix 2. [12-14]. 
● Patients’ motivation to give up smoking (Richmond test). See Appendix 3 [15]. 
● Health-related quality of life: Measured through the following questionnaires: 
○ EuroQol-5D. See Appendix 4 [16]. This questionnaire describes health status making 
use of five dimensions (mobility, self-care, usual activities, pain/discomfort and 
anxiety/depression), and each dimension is further assessed with five levels of 
severity. 
○ SF-36. See Appendix 5 [17]. The SF-36 consists of eight scaled scores, which are the 
weighted sums of the questions in their section. Each scale is directly transformed 
into a 0-100 scale on the assumption that each question carries equal weight. The 
lower the score the more disability. The eight sections are: 
a) Vitality 
b) Physical functioning 
c) Bodily pain 
d) General health perceptions 
e) Physical role functioning 
f) Emotional role functioning 
g) Social role functioning 
h) Mental health. 
● Physical activity: Measured through the Physical Activity International Questionnaire (IPAQ-
27). See Appendix 6 [18]. The IPAQ-27 questionnaire aims to provide common metrics to 
gather internationally comparable data regarding health related physical activity. 

● Exhaled carbon monoxide (CO). Exhaled CO is part of the smoke, and can be measured by a 
CO tester. The subject must perform a deep inspiration and hold the air for 15 seconds. 
Afterwards, the subject must exhale the air inside the CO tester (Micro+ Smokerlyzer®) in a 
slow, sustained and complete fashion. The CO tester then yields the exact number of exhaled 
CO parts per million (ppm). Highest exhaled CO levels are found between 3 and 6 hours after 
smoking a cigarette. A person is considered to be smoker when his/her exhaled CO is higher 
than 6 ppm [19]. A more detailed classification is shown in the Table 2 [1]. 
 
 
CO (ppm) 
Kind of smoker 
CO ≥ 10 
Usual 
5 < CO < 10 
Occasionally 
 CO ≤ 5 
Non smoker 
Table 2. Smoker classification regarding exhaled CO in ppm. 
  
● Urine Cotinine (SmokeScreen® test). It is a colorimetric test that measures the main 
metabolites of the nicotine, including the cotinine. Subjects with cotinine concentrations over 
200 ng/ml are considered as smokers [20]. 
8.1.2 Follow-up 
The follow-up will be carried out according to the following schedule: 
● Basal consultation. The patient is assessed for the first time at the Smoking Cessation Unit as 
he/she is referred from either Pneumology Unit or another clinical department. All the 
information fields included in the Appendix 1 will be collected. In this consultation all the 
patients will sign the informed consent. 
● 2nd consultation. 15 (± 5) days after the basal consultation. Information regarding the 
following sections will be collected: smoking related symptoms, treatment adherence, daily 
cigarettes, possible adverse events, exhaled CO, cotinine test, clinical information. Relaxation 
techniques and risk avoiding techniques are also explained to the subject. 
● 3rd consultation. 30 (± 5) days after the basal consultation. Information regarding the 
following sections will be collected: smoking related symptoms, treatment adherence, 
possible adverse events, exhaled CO, cotinine test, clinical information. New relaxation 
techniques are explained in case the former resulted useless. Coaching for relapse prevention 
is performed. 

● 4th consultation. 60 (± 5) days after the basal consultation. Information regarding the 
following sections will be collected: smoking related symptoms, treatment adherence, and 
possible adverse events. Risk avoiding techniques are reinforced. 
● 5th consultation. 90 (± 5) days after the basal consultation. Information regarding the 
following sections will be collected: physical and psychological health state, exhaled CO, 
cotinine test, and clinical information. 
● 6th consultation. 120 (± 5) days after the basal consultation. The patient could be assessed by 
phone in case he/she has completed the pharmacological treatment. Information regarding 
symptoms related to abstinence will be collected in this session. Coaching for relapse 
prevention is performed and confronting techniques are explained to the subject. 
● 7th consultation. 180 (± 5) days after the basal consultation. Information regarding the 
following sections will be collected: exhaled CO, cotinine test, clinical information, quality of 
life (EuroQoL 5D questionnaire) and physical activity monitoring (IPAQ-27 questionnaire). 
Relaxation and confronting techniques are reinforced when needed. 
● 8th consultation. 365 (± 5) days after the basal consultation. Information regarding the 
following sections will be collected: exhaled CO, cotinine test, blood pressure, weight, height, 
quality of life (EuroQoL 5D and SF-36 questionnaires) and physical activity monitoring 
(IPAQ-27 questionnaire). 
 
In order to facilitate the follow-up process, patients will occasionally be assessed by phone in case 
physical presence in the consultation is not mandatory. 
8.2 Duration of study participation 
The assessment and follow-up of the patients included in the study will be carried out during 12 
months in the Smoking Cessation Unit of Virgen del Rocío University Hospital 
 
 
 

9. Trial medication 
9.1 Treatment plan 
9.1.1 Bupropion therapy 
Bupropion is the first nicotine-free drug approved for smoking cessation purposes. It is an atypical 
antidepressant which acts as inhibitor of dopamine and noradrenaline receptors, with an antagonistic 
and noncompetitive role of the nicotine receptor, improving the symptoms of the abstinence 
syndrome. It is formulated as a 150 mg long discharge pill, usually being prescribed a daily dose of 
300 mg, except for week one which would be prescribed 150 mg per day. The usual length of the 
treatment ranges from 7 to 9 weeks. However, 12 weeks treatments could be prescribed for severe 
cases of smokers. Even though it is considered as a state of the art treatment to quit smoking, its use 
has been limited due to the risk of its interaction with various drugs regarding its liver metabolism 
through cytrochrome P450 and the risk of important side effects in certain groups of patients. It 
doubles the rates of abstinence against a placebo. Although its efficiency can be improved in 
combination with NRT, it does not outperform the combination of varenicline and NRT [11]. 
 
9.1.2 Varenicline therapy 
Varenicline is the first drug specifically designed as a smoking cessation treatment. It is a partial 
antagonist of the α4β2 nicotine receptors. Thanks to its antagonist action, it stimulates these receptors 
thus improving abstinence syndrome and cravings symptoms. On the other hand, its antagonist role 
produces a receptor blocking, decreasing the pleasure associated to the consumption of nicotine. It has 
a high profile of safety due to the lack of liver metabolism and its effect on the kidney protein 
conveyors. Additionally, it does not present any interaction with other drugs. The dose should be 
adjusted in case the patient suffers from severe kidney failure. 
 
Its side effects are mild and decrease with the time, although sometimes it may be necessary to reduce 
the dose. On its own, is the most effective treatment to quit smoking. It triples the efficacy from 
placebo, being higher than the combination of bupropion and NRT, and achieves a similar efficacy 
when combined with NRT [11]. It is formulated as 0,5 mg and 1 mg pills, and the dose should be 
progressively incremented during the first days in order to facilitate tolerance. The recommended 
length of the treatment is 12 weeks, although longer treatments could be necessary for severe 
smokers. There is evidence of increased efficacy and safety at 6 and 12 months [21, 22]. The cessation 
consumption of tobacco with varenicline, according to the usual pattern of performance, must be 
performed after the first week of treatment.  

 
However there is a study that highlights increased abstinence rates when a pretreatment regimen of 4 
weeks prior the beginning of the smoking cessation process is carried out [23]. The usual dose is 2 
mg/day. 
 
 
Drug 
Week before day D 
From day D to 12 weeks 
Varenicline 
Day 1-3 
Day 4-7 
1mg/12h 
0.5mg/24h 
0.5mg/12h 
 
Table 4. Doses of varenicline. 
9.2   Treatment Assignment procedures 
9.2.1 Randomization 
Currently, Smoking Cessation Unit of Virgen del Rocío University Hospital proposes a treatment 
consisting of psycho-pharmacological therapy. In addition, pharmacological therapy includes 2 
different medications: bupropion and varenicline. 
 
Therefore, the selection of patients will be made randomly on a 2 stage process: 
● 1st stage: Randomization between So-Lo-Mo intervention (intervention group) and usual 
intervention (control group). 
● 2nd stage: Pharmacological therapy will be prescribed randomly to both intervention and 
control groups. 
 
Both pharmacological therapy and So-Lo-Mo intervention will be provided for free to our patients. 
 
 
 
 
 
 

10. Safety monitoring 
10.1 Adverse Events (AE) 
10.1.1 Definition 
An adverse event could be considered as any untoward medical occurrence that may present during 
treatment with a pharmaceutical product but which does not necessarily have a causal relationship 
with this treatment [24]. 
 
An adverse event can arise from any use of the drug (e.g., off-label use, use in combination with 
another drug) and from any route of administration, formulation, or dose, including an overdose. 
10.1.2 Adverse events of the different treatments 
 
Drug 
Adverse effects 
  
Bupropion 
Insomnia. 
Headache. 
Dryness in the mouth. Alteration of taste. 
Skin reactions 
Convulsions, cardiovascular side effects and severe skin 
reactions.  
Varenicline 
Nausea, vomit. 
Headache. 
Insomnia, abnormal dreams. 
Constipation, flatulence 
  
Table 5. Adverse effects 
 
 
 
 

11. Statistical considerations and analytical plan 
11.1 Responsibility for analysis 
The statistical analysis of the data obtained from this study will be the responsibility of SAS 
researchers. 
11.2 Justification of sample size 
Total patient sample to be included in the trial will be 240 patients. 120 of them will take part in the 
intervention group (So-Lo-Mo intervention) and 120 patients will act as the control group undergoing 
the usual care.  
This sample size is not based on power calculations. To estimate the sample size the following 
premises have been taken into account: 
● Total number of smoking population attending to the Smoking Cessation Unit of Virgen del 
Rocío University Hospital during one year. 
● Number of months available to recruit patients. 
11.3 Data analysis 
● A descriptive analysis of patients’ characteristics by absolute and relative frequencies for 
qualitative variables and average +/- standard deviation for quantitative variables will be 
carried out at the end of the study. 
● Furthermore, a bivariate analysis of study groups will be performed for qualitative variables 
by chi-square test or Fisher's exact test. Comparison of quantitative variables will be different 
depending on technical assumptions parametric (Student t-test or ANOVA) or nonparametric 
(Mann-Whitney U-or Kruskal-Wallis). 
● For cost analysis of the healthcare resources, costs of clinical interventions and equipment 
will be assessed according to current Spanish public health prices. 
 
 
 
 

12. References 
[1] Manejo diagnóstico y tratamiento del tabaquismo en la práctica clínica diaria. (2015). Manual 
SEPAR de procedimientos. 
[2] WHO, Priority Medicine for Europe and the World 2013 Update 
(http://www.who.int/medicines/areas/priority_medicines/MasterDocJune28_FINAL_Web.pdf) 
[3] World Health Organization. Tobacco‐  Fact Sheet No339, July 2013. Available from: 
http://www.who.int/mediacentre/factsheets/fs339/en/ (accessed 21 September 2013). 
[4]The World Health Report 2002—Reducing Risks, Promoting Healthy Life 
(http://www.who.int/whr/2002/en/) 
[5] Ramo, D. E., Thrul, J., Chavez, K., Delucchi, K. L., & Prochaska, J. J. (2015). Feasibility and Quit 
Rates of the Tobacco Status Project: A Facebook Smoking Cessation Intervention for Young Adults. 
Journal of medical Internet research, 17(12), e291. 
[6] Williams, G., Hamm, M. P., Shulhan, J., Vandermeer, B., & Hartling, L. (2014). Social media 
interventions for diet and exercise behaviours: a systematic review and meta-analysis of randomised 
controlled trials. BMJ open, 4(2), e003926. 
[7] King, D., Greaves, F., Exeter, C., & Darzi, A. (2013). ‘Gamification’: Influencing health 
behaviours with games. Journal of the Royal Society of Medicine, 106(3), 76‐ 78. 
[8] Lanza, S. T., Vasilenko, S. A., Liu, X., Li, R., & Piper, M. E. (2013). Advancing the understanding 
of craving during smoking cessation attempts: A demonstration of the time‐ varying effect model. 
Nicotine & Tobacco Research, ntt128. 
[9] Stead LF, Perera R, Lancaster T. Telephone counselling for smoking cessation. Cochrane Database 
Syst Rev. 2006; 3:CD002850.  
[10] Myung SK, McDonnell DD, Kazinets G, Seo HG, Moskowitz JM. Effects of web and computer-
based smoking cessation programs: Meta-analysis of randomized controlled trials. Arch Intern Med. 
2009; 169:929–37.  
[11] Kate Cahill, Sarah Stevens, Rafael Perera, Tim Lancaster. Pharmacological interventions 
for smoking cessation: an overview and network meta-analysis. Cochrane Database of 
Systematic Reviews. 2013. 
[12] Fageström KO. Measuring degree of physical dependence to tobacco smoking with reference to 
individualization of treatment. Addict Behav 1978; 3: 235-41. 12.- 
[13] Fageström K, Scheineder N. Measuring nicotine dependence. A review of the Fagerström 
tolerance questionaire. J Behav Med 1989; 12: 159-82. 13. 
[14] Heatherton T, Kozlowski L, Frecker R, Fageström K. The Fagerström test for nicotine 
dependence: a review of the Fagerström tolerance questionnaire. Br J Addiction 1991; 86: 1119-27. 
[15] Richmond L, Kehoe L, Webster IW. Multivariate models for predicting abstention following 
intervention to stop smoking by general practitioner. Addiction 1993; 88: 1127-35 

[16]  Euroqol-5D-5L. Available at: http://www.euroqol.org/home.html. 
[17]  sechc.es/files/investigacion/calidad-vida/sf_36_fid276.pdf 
[18] Booth, M.L. (2000).  Assessment of Physical Activity: An International Perspective.  Research 
Quarterly for Exercise and Sport, 71 (2): s114-20.  
[19] Pearce MS, Hayes L. Self-reported smoking status and exhaled carbon monoxide: results from 
two population-based epidemiologic studies in the North of England. Chest. 2005 Sep;128(3):1233-8 
[20] Pérez Trullén A, Bartomeu C, Barrueco M, Herrero I, Jiménez Ruiz CA. Nuevas perspectivas en 
el diagnóstico y evolución en el consumo de tabaco: marcadores de exposición. Prev Tab. 2006; 
8:164–73. 
 [21]  Tonstad S, Tonnesen P, Hajek P, Williams K, Billing C, Reeves K, et al. Effect of maintenance 
therapy with varenicline on smoking cessation: A randomized controlled trial. JAMA. 2006; 296:64–
71. 15. 
[22] Reeves K, Watsky E, Williams K, et al. 2006. The safety of varenicline taken for 52 weeks for 
smoking cessation. Society for Research on Nicotine and Tobacco 12th Annual Conference Orlando, 
FL, USA. 
[23] Hajek P, McRobbie HJ, Myers KE, Stapleton J, Dhanji AR. Use of varenicline for 4 weeks before 
quitting smoking: Decrease in ad lib smoking and increase in smoking cessation rates. Archives of 
Internal Medicine. 2011; 171(8):770–7. 
[24] Farlex Partner Medical Dictionary © Farlex 2012 
  
 
 
 

13. Appendices 
Appendix 1. Smoker form  
RESPIRATORY DISEASES SURGICAL AND CLINICAL UNIT 
Smoke Cessation Unit 
Medical Doctors 
Francisco Ortega Ruiz 
Pilar Núñez Castillo 
Laura Carrasco Hernández 
Psychologist 
Marco Mesa González 
Nurse 
Mercedes Molina Martínez 
 
DATE: _____________________________ 
NAME: _________________________________________________________ 
SURNAME: _____________________________________________________ 
NATIONAL ID: _______________________ 
HEALTH ID: _________________________ 
DATE OF BIRTH: __________ 
GENDER: ___ Male   ___ Female 
PROFFESION: ___________________________________________________ 
UNEMPLOYED: ___ YES   ___ NO 
PHONE NUMBER(S): _____________________ / ______________________ 
SMARTPHONE AVAILABILITY: ___ YES   ___ NO 
  
CONSUMPTION HISTORY 
AGE AT START: __________ 
NUMBER OF DAILY CIGARETTES: 
  
S1 
S2 
S3 
Daily cigarettes 
  
  
  
LIVE-IN RELATIVES SMOKERS?: ___ YES   ___ NO 
FRIENDS/PARTNERS SMOKERS?: ___ YES   ___ NO 
PRECEDENT QUITTING ATTEMPTS: __________ 
WHEN: ______________________ 
MAX TIME OF ABSTINENCE: __________ 
TYPE OF TREATMENT: ____________________________________________ 
RELAPSE REASON: _______________________________________________ 
 
 

 
COOXIMETRY (CO ppm): 
  
S1 
S2 
S3 
S5 
S7 
S8 
Co-oximetry (ppm) 
  
  
  
  
  
  
  
COTININE URINE TEST (ng/ml): 
  
S1 
S2 
S3 
S7 
S8 
Cotinine (ng/ml) 
  
  
  
  
  
  
OBSERVATIONS: 
__________________________________________________________________________________
__________________________________________________________________________________
______________________________________________ 
  
SMOKING RELATED SYMPTOMS: 
  
S1 
Morning cough 
___ YES   ___ NO  
Expectoration 
___ YES   ___ NO  
Respiratory difficulty 
___ YES   ___ NO  
Sibilant breath 
___ YES ___ NO 
Frequent colds 
___ YES   ___ NO 
Throat ache 
___ YES   ___ NO 
Dysgeusia 
___ YES   ___ NO 
Halitosis 
___ YES   ___ NO 
Stomach ache 
___ YES   ___ NO 
Heavy digestions 
___ YES   ___ NO 
Headache 
___ YES   ___ NO 
Chest ache 
___ YES   ___ NO 
Legs aching while walking 
___ YES   ___ NO 
Dizziness 
___ YES   ___ NO 

Insomnia 
___ YES   ___ NO 
Palpitations 
___ YES   ___ NO 
Nervousness 
___ YES   ___ NO 
Sexual problems 
___ YES   ___ NO 
Others:  
___ YES   ___ NO 
  
CLINICAL INFORMATION: 
  
S1 
S2 
S3 
S5 
S7 
S8 
Weight (Kg) 
  
  
  
  
  
  
Size (cm) 
  
  
  
  
  
  
BMI 
  
  
  
  
  
  
Blood Pressure (mmHg) 
/ 
/ 
/ 
/ 
/ 
/ 
  
COMORBIDITIES: 
NONE:  
 
__________________ 
DIABETES:             
__________________ 
CHOLESTEROL:     
__________________ 
HEART STROKE:   
__________________ 
ARRHYTHMIAS:        __________________ 
HYPERTENSION:   
__________________ 
INSOMNIA:             
__________________ 
COPD:                     
__________________ 
EPILEPSY:               
__________________ 
SKIN DISEASES:    
__________________ 
DEPRESSION:         
__________________ 
ANXIETY:               
__________________ 
  
Observations: Current treatments, familiar history, … 
__________________________________________________________________________________
__________________________________________________________________________________
______________________________________________ 
 
 

DEPENDENCY (FAGERSTRÖM TEST) 
(See Appendix 2) 
 
MOTIVATION (RICHMOND TEST) 
(See Appendix 3)   
  
  
S1 
FAGERSTRÖM score 
  
RICHMOND score 
  
  
Patient motivation:  
  
S2 
S3 
S4 
S5 
S6 
S7 
High 
  
  
  
  
  
  
Moderated 
 
 
 
 
 
 
Low 
 
 
 
 
 
 
  
 
PHARMACOLOGICAL TREATMENT FOR SMOKE CESSATION: 
  
 
Y 
N 
Behavioral Therapy + Varenicline 
  
  
Behavioral Therapy + Varenicline + So-Lo-Mo 
  
  
Behavioral Therapy + Bupropion 
 
 
Behavioral Therapy + Bupropion + So-Lo-Mo 
 
 
  
  
Why have you planned to quit smoking now? 
__________________________________________________________________________________
__________________________________________________________ 
 
Why do you think it is a good time to quit smoking? 
__________________________________________________________________________________
__________________________________________________________ 
  
 
 
 

PSYCHO-PHYSIOLOGICAL SYMPTOMS RELATED TO SMOKING ABSTINENCE 
  
(0=No, 1=Mild, 2=Moderate, 3=Intense) 
  
 
S2 
S3 
S4 
S5 
S6 
Craving 
  
  
  
  
  
Irritability 
  
  
  
  
  
Anxiety 
  
  
  
  
  
Unease 
  
  
  
  
  
Lack of concentration 
  
  
  
  
  
Appetite rising 
  
  
  
  
  
Lack of energy 
  
  
  
  
  
Somnolence 
  
  
  
  
  
Insomnia 
  
  
  
  
  
Constipation 
  
  
  
  
  
   
Quality of Life 
(See Appendices 4 and 5) 
  
  
S1 
S7 
S8 
EuroQoL-5D score 
 
 
 
SF-36 score 
 
N/A 
 
 
Physical Exercise Monitoring 
(See Appendix 6) 
  
  
S1 
S7 
S8 
IPAQ-27 score 
 
 
 
 
 
 
 
 
 

OBSERVATIONS: 
Resources devoted to the patient between scheduled sessions (off the protocol): 
Session interval 
S1-S2 
S2-S3 
S3-S4 
S4-S5 
S5-S6 
S6-S7 
S7-S8 
Time devoted to the patient (min) 
  
  
  
  
  
  
  
Number of telephone consultations 
  
  
  
  
  
  
  
Number of in-person consultations 
  
  
  
  
  
  
  
Number of email consultations 
  
  
  
  
  
  
  
  
General observations: 
__________________________________________________________________________________
_______________________________________________________________________ 
 
 
 

Appendix 2. Fagerström test 
 

 
 
 
 

Appendix 3. Richmond test 
Name:  
 
Answer the following questions, sincerely, please. 
 
1. Do you want to give up smoking? 
 
 
0. No  
 
 
1. Yes 
 
2. How much motivation do you have to give up smoking? 
 
 
 
0. Nothing 
1.A bit  
2.Enough 
    3. A lot 
 
3. Will you try to give up smoking next 2 weeks? 
 
 
0. No   
1. Maybe 
2. Probably 
     3. Yes 
 
4. Do you believe that you will not smoking in 6 months? 
 
 
0. No   
1. Maybe 
2. Probably 
     3. Yes 
 
 
 
 
High motivation: 10 points 
 
Moderate motivation: 7-9 
Low motivation: ≤6 
 
 
 
 

Appendix 4. EuroQol-5D 
 

 

 
 
 
 

Appendix 5. SF-36 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
 
 
 

 
 
 
 
 

 
 
 
 

 
 
 
 
 

Appendix 6. IPAQ-27 
 
CUESTIONARIO INTERNACIONAL DE ACTIVIDAD FÍSICA 
(Octubre de 2002) 
 
VERSIÓN LARGA FORMATO AUTO ADMINISTRADO - 
ÚLTIMOS 7 DÍAS 
 
 
PARA USO CON JÓVENES Y ADULTOS DE 
MEDIANA EDAD (15-69 años) 
 
Los Cuestionarios Internacionales de Actividad Física (IPAQ, por sus siglas en inglés) 
contienen un grupo de 4 cuestionarios. La versión larga (5 objetivos de actividad evaluados 
independientemente) y una versión corta (4 preguntas generales) están disponibles para 
usar por los métodos por teléfono o auto administrada. El propósito de los cuestionarios es 
proveer instrumentos comunes que pueden ser usados para obtener datos 
internacionalmente comparables relacionados con actividad física relacionada con salud. 
 
Antecedentes del  IPAQ 
El desarrollo de una medida internacional para actividad física comenzó en Ginebra en 1998 
y fue seguida de un extensivo exámen de confiabilidad y validez hecho en 12 países (14 
sitios) en el año 2000. Los resultados finales sugieren que estas medidas tienen aceptables 
propiedades de medición para usarse en diferentes lugares y en diferentes idiomas, y que 
son apropiadas para estudios nacionales poblacionales de prevalencia de participación en 
actividad física. 
  
Uso del IPAQ  
Se recomienda el uso de los instrumentos IPAQ con propósitos de monitoreo e 
investigación. Se recomienda que no se hagan cambios en el orden o redacción de las 
preguntas ya que esto afectará las propiedades sicométricas de los instrumentos. 
 
Traducción del Inglés y Adaptación Cultural 
Traducción del Inglés es sugerida para facilitar el uso mundial del IPAQ. Información acerca 
de la disponibilidad del IPAQ en diferentes idiomas puede ser obtenida en la página de 
internet www.ipaq.ki.se. Si se realiza una nueva traducción recomendamos 
encarecidamente usar los métodos de traducción nuevamente al Inglés disponibles en la 
página web de IPAQ.  En lo possible por favor considere poner a disposición de otros su 
version traducida en la página web de IPAQ. Otros detalles acerca de traducciones y 
adaptación cultural pueden ser obtenidos en la página web. 
  
Otros Desarrollos de IPAQ  
Colaboración Internacional relacionada con IPAQ es continua y un Estudio Internacional 
de Prevalencia de Actividad Física se encuentra en progreso. Para mayor información 
consulte la página web de IPAQ. 

 
Información Adicional 
Información más detallada del proceso IPAQ y los métodos de investigación usados en el 
desarrollo de los instrumentos IPAQ se encuentra disponible en la página www.ipaq.ki.se y 
en Booth, M.L. (2000).  Assessment of Physical Activity: An International Perspective.  
Research Quarterly for Exercise and Sport, 71 (2): s114-20.  Otras publicaciones científicas 
y presentaciones acerca del uso del IPAQ se encuentran resumidas en la página Web. 

CUESTIONARIO INTERNACIONAL DE ACTIVIDAD FÍSICA 
 
Estamos interesados en saber acerca de la clase de actividad física que la gente 
hace como parte de su vida diaria. Las preguntas se referirán acerca del tiempo que 
usted utilizó siendo físicamente activo(a) en los últimos 7 días. Por favor responda 
cada pregunta aún si usted no se considera una persona activa. Por favor piense en 
aquellas actividades que usted hace como parte del trabajo, en el jardín y en la 
casa, para ir de un sitio a otro, y en su tiempo libre de descanso, ejercicio o deporte. 
  
Piense acerca de todas aquellas actividades vigorosas y moderadas que usted 
realizó en los últimos 7 días. Actividades vigorosas son las que requieren un 
esfuerzo físico fuerte y le hacen respirar mucho más fuerte que lo normal. 
Actividades moderadas son aquellas que requieren un esfuerzo físico moderado y 
le hace respirar algo más fuerte que lo normal. 
 
PARTE 1: ACTIVIDAD FÍSICA RELACIONADA CON EL TRABAJO 
 
La primera sección es relacionada con su trabajo. Esto incluye trabajos con salario, 
agrícola, trabajo voluntario, clases, y cualquier otra clase de trabajo no pago que 
usted hizo fuera de su casa. No incluya trabajo no pago que usted hizo en su casa, 
tal como limpiar la casa, trabajo en el jardín, mantenimiento general, y el cuidado de 
su familia. Estas actividades serán preguntadas en la parte 3. 
 
1. 
¿Tiene usted actualmente un trabajo o hace algún trabajo no pago fuera de 
su casa? 
 
 
Sí 
 
 
No 
Pase a la PARTE 2: TRANSPORTE 
 
 
Las siguientes preguntas se refieren a todas las actividades físicas que usted hizo 
en los últimos 7 días como parte de su trabajo pago o no pago. Esto no incluye ir y 
venir del trabajo.  
 
2. 
Durante los últimos 7 días, ¿Cuántos días realizó usted actividades físicas 
vigorosas como levantar objetos pesados, excavar, construcción pesada, o 
subir escaleras como parte de su trabajo? Piense solamente en esas 
actividades que usted hizo por lo menos 10 minutos continuos.  
 
_____ días por semana 

 
 
Ninguna actividad física vigorosa relacionada con el trabajo               
 
Pase a la pregunta 4 
 
 
No sabe/No está seguro(a) 
 
3. 
¿Cuánto tiempo en total usualmente le toma realizar actividades físicas 
vigorosas en uno de esos días que las realiza como parte de su trabajo? 
 
_____ horas por día 
_____ minutos por día 
 
 
No sabe/No está seguro(a) 
 
 
 
 
4. 
Nuevamente, piense solamente en esas actividades que usted hizo por lo 
menos 10 minutos continuos.  Durante los últimos 7 días, ¿Cuántos días 
hizo Usted actividades físicas moderadas como cargar cosas ligeras como 
parte de su trabajo? Por favor no incluya caminar. 
 
_____ días por semana 
 
 
No actividad física moderada relacionada con el trabajo 
 
 
Pase a la pregunta 6 
 
 
5. 
¿Cuánto tiempo en total usualmente le toma realizar actividades físicas 
moderadas en uno de esos días que las realiza como parte de su trabajo? 
 
_____ horas por día 
_____ minutos por día 
 
 
 
No sabe/No está seguro(a) 
 
6. 
Durante los últimos 7 días, ¿Cuántos días caminó usted por lo menos 10 
minutos continuos como parte de su trabajo? Por favor no incluya ninguna 
caminata que usted hizo para desplazarse de o a su trabajo.  
 
_____ días por semana 
 
 
Ninguna caminata relacionada con trabajo 
 
Pase a la PARTE 2: TRANSPORTE 
 
 
7. 
¿Cuánto tiempo en total pasó generalmente caminado en uno de esos días 
como parte de su trabajo? 
 

_____ horas por día 
_____ minutos por día 
 
No sabe/No está seguro(a)

PARTE 2: ACTIVIDAD FíSICA RELACIONADA CON TRANSPORTE 
 
Estas preguntas se refieren a la forma como usted se desplazó de un lugar a otro, 
incluyendo lugares como el trabajo, las tiendas, el cine, entre otros. 
 
8. 
Durante los últimos 7 días, ¿Cuántos días viajó usted en un vehículo de 
motor  como un tren, bus, automóvil, o tranvía? 
 
_____ días por semana 
 
 
No viajó en vehículo de motor 
Pase a la pregunta 10 
 
 
9. 
Usualmente, ¿Cuánto tiempo gastó usted en uno de esos días viajando en 
un tren, bus, automóvil, tranvía u otra clase de vehículo de motor? 
 
_____ horas por día 
_____ minutos por día 
 
 
 
No sabe/No está seguro(a) 
 
 
Ahora piense únicamente acerca de montar en bicicleta o caminatas que usted 
hizo para desplazarse a o del trabajo, haciendo mandados, o para ir de un lugar a 
otro. 
 
10. 
Durante los últimos 7 días, ¿Cuántos días montó usted en bicicleta por al 
menos 10 minutos continuos para ir de un lugar a otro?  
 
_____ días por semana 
 
 
No montó en bicicleta de un sitio a otro 
Pase a la pregunta 12 
 
 
11. 
Usualmente, ¿Cuánto tiempo gastó usted en uno de esos días montando en 
bicicleta de un lugar a otro? 
 
_____ horas por día 
_____ minutos por día 
 
 
 
No sabe/No está seguro(a) 

12. 
Durante los últimos 7 días, ¿Cuántos días caminó usted por al menos 10 
minutos continuos para ir de un sitio a otro?  
 
_____ días por semana 
 
 
No caminatas de un sitio a otro 
Pase a la PARTE 3: 
TRABAJO DE LA CASA, 
MANTENIMIENTO DE LA 
CASA, Y CUIDADO DE LA 
FAMILIA 
 
 
13. 
Usualmente, ¿Cuánto tiempo gastó usted en uno de esos días caminando 
de un sitio a otro? 
 
_____ horas por día 
_____ minutos por día 
 
No sabe/No está seguro(a)

PARTE 3: TRABAJO DE LA CASA, MANTENIMIENTO DE LA CASA, Y 
CUIDADO DE LA FAMILIA 
 
Esta sección se refiere a algunas actividades físicas que usted hizo en los últimos 7 
días en y alrededor de su casa tal como como arreglo de la casa, jardinería, trabajo 
en el césped, trabajo general de mantenimiento, y el cuidado de su familia. 
 
14. 
Piense únicamente acerca de esas actividades físicas que hizo por lo menos 
10 minutos continuos. Durante los últimos 7 días, ¿Cuántos días hizo usted 
actividades físicas vigorosas tal como levantar objetos pesados, cortar 
madera, palear nieve, o excavar en el jardín o patio? 
 
_____ días por semana 
 
 
Ninguna actvidad física vigorosa en el jardín o patio 
 
Pase a la pregunta 16 
 
 
15. 
Usualmente, ¿Cuánto tiempo dedica usted en uno de esos días haciendo 
actividades físicas vigorosas en el jardín o patio? 
 
_____ horas por día 
_____ minutos por día 
 
 
 
No sabe/No está seguro(a) 
 
 
16. 
Nuevamente, piense únicamente acerca de esas actividades físicas que hizo 
por lo menos 10 minutos continuos. Durante los últimos 7 días, ¿Cuántos 
días hizo usted actividades físicas moderadas tal como cargar objetos 
livianos, barrer, lavar ventanas, y rastrillar en el jardín o patio? 
 
_____ días por semana 
 
 
Ninguna actvidad física moderada en el jardín o patio 
 
 
Pase a la pregunta 18 
 
 
17. 
Usualmente, ¿Cuánto tiempo dedica usted en uno de esos días haciendo 
actividades físicas moderadas en el jardín o patio? 
 
_____ horas por día 
_____ minutos por día 
 
 
 
No sabe/No está seguro(a) 

18. 
Una vez más,  piense únicamente acerca de esas actividades físicas que hizo 
por lo menos 10 minutos continuos. Durante los últimos 7 días, ¿Cuántos 
días hizo usted actividades físicas moderadas tal como cargar objetos 
livianos, lavar ventanas, estregar pisos y barrer dentro de su casa? 
 
_____ días por semana 
 
 
Ninguna actvidad física moderada dentro de la casa 
 
 
Pase a la PARTE 4: 
ACTIVIDADES FíSICAS DE 
RECREACIÓN, DEPORTE 
Y TIEMPO LIBRE 
 
 
19. 
Usualmente, ¿Cuánto tiempo dedica usted en uno de esos días haciendo 
actividades físicas moderadas dentro de su casa? 
 
_____ horas por día 
_____ minutos por día 
 
No sabe/No está seguro(a)

PARTE 4: ACTIVIDADES FíSICAS DE RECREACIÓN, DEPORTE Y 
TIEMPO LIBRE 
 
Esta sección se refiere a todas aquellas actividades físicas que usted hizo en los 
últimos 7 días únicamente por recreación, deporte, ejercicio o placer. Por favor no 
incluya ninguna de las actividades que ya haya mencionado. 
 
20. 
Sin contar cualquier caminata que ya haya usted mencionado, durante los 
últimos 7 días, ¿Cuántos días caminó usted por lo menos 10 minutos 
continuos en su tiempo libre?  
 
_____ días por semana 
 
 
Ninguna caminata en tiempo libre 
Pase a la pregunta 22 
 
21. 
Usualmente, ¿Cuánto tiempo gastó usted en uno de esos días caminando 
en su tiempo libre? 
 
_____ horas por día 
_____ minutos por día 
 
 
No sabe/No está seguro(a) 
 
 
22. 
Piense únicamente acerca de esas actividades físicas que hizo por lo menos 
10 minutos continuos. Durante los últimos 7 días, ¿Cuántos días hizo usted 
actividades físicas vigorosas tal como aeróbicos, correr, pedalear rápido en 
bicicleta, o nadar rápido en su tiempo libre?  
 
_____ días por semana 
 
 
Ninguna actividad física vigorosa en tiempo libre 
 
 
Pase a la pregunta 24 
 
23. 
Usualmente, ¿Cuánto tiempo dedica usted en uno de esos días haciendo 
actividades físicas vigorosas en su tiempo libre? 
 
_____ horas por día 
_____ minutos por día 
 
No sabe/No está seguro(a) 
 
 
 
 
 
24. 
Nuevamente, piense únicamente acerca de esas actividades físicas que hizo 
por lo menos 10 minutos continuos. Durante los últimos 7 días, ¿Cuántos 
días hizo usted actividades físicas moderadas tal como pedalear en bicicleta 

a paso regular, nadar a paso regular, jugar dobles de tenis, en su tiempo 
libre? 
 
_____ días por semana 
 
 
Ninguna actvidad física moderada en tiempo libre 
 
 
Pase a la PARTE 5: TIEMPO DEDICADO A ESTAR SENTADO(A) 
 
25. 
Usualmente, ¿Cuánto tiempo dedica usted en uno de esos días haciendo 
actividades físicas moderadas en su tiempo libre? 
_____ horas por día 
_____ minutos por día 
 
No sabe/No está seguro(a)

PARTE 5: TIEMPO DEDICADO A ESTAR SENTADO(A) 
 
Las últimas preguntas se refieren al tiempo que usted permanence sentado(a) en el 
trabajo, la casa, estudiando, y en su tiempo libre. Esto incluye tiempo sentado(a) en 
un escritorio, visitando amigos(as), leyendo o permanecer sentado(a) o acostado(a) 
mirando television. No incluya el tiempo que permanence sentado(a) en un vehículo 
de motor que ya haya mencionado anteriormente. 
 
26. 
Durante los últimos 7 días, ¿Cuánto tiempo permaneció sentado(a) en un 
día en la semana? 
 
_____ horas por día 
_____ minutos por día 
 
 
No sabe/No está seguro(a) 
 
 
27. 
Durante los últimos 7 días, ¿Cuánto tiempo permaneció sentado(a) en un 
día del fin de semana? 
 
_____ horas por día 
_____ minutos por día 
 
 
No sabe/No está seguro(a) 
 
 
 
Este es el final del cuestionario, gracias por su participación.