Clinical trial NCT03553173: So-Lo-Mo Intervention Applied to the Smoking Cessation Process
Official 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Health Behavior
Lifestyle-related Condition
Keywords: Smoking Cessation
App
Decision Support System
Lead sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Sponsor class: OTHER
Collaborators: name: European Commission
name: Andaluz Health Service
First posted: 2018-06-12
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized open-label parallel-group trial.
Primary purpose: TREATMENT

Brief summary: This is a randomized open-label parallel-group trial. 240 subjects will be recruited during 8 months and a 12 months follow-up will be carried out for each one of them. 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.

Detailed description: The main objective of this study is to analyze the efficacy and efficiency of the So-Lo-Mo intervention applied to the smoking cessation process compared to usual care.

Secondary objectives are:

1. To monitor usual psycho-pharmacological therapies (bupropion, varenicline and behavioural therapy).
2. To monitor healthy lifestyle and physical exercise habits.

Eligibility criteria: 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 smart phone availability.
* Ability to interact with the smart phone.
* To sign an Informed Consent Form.

Exclusion Criteria:

* Subjects had some previous adverse effects related to the pharmacological treatment included in the study

Primary outcomes:
measure: Efficacy: Smoking abstinence rate
timeFrame: 1 year
measure: Efficiency: Incremental Cost-Effectiveness Ratio
timeFrame: 1 year
Secondary outcomes:
measure: Incidence of Treatment-Related Adverse Events [Safety]
timeFrame: 1 year
measure: International Physical Activity Questionnaire (IPAQ27) score [Physical activity]
timeFrame: From baseline (first evaluation in the study) to 1 year after
measure: Body Mass Index (BMI) in kg/m^2 [Healthy lifestyle]
timeFrame: From baseline (first evaluation in the study) to 1 year after
Other outcomes:
Locations:
Study officials:
affiliation: Virgen del Rocío University Hiospital
name: Francisco Ortega-Ruiz, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hartmann-Boyce J, Theodoulou A, Farley A, Hajek P, Lycett D, Jones LL, Kudlek L, Heath L, Hajizadeh A, Schenkels M, Aveyard P. Interventions for preventing weight gain after smoking cessation. Cochrane Database Syst Rev. 2021 Oct 6;10(10):CD006219. doi: 10.1002/14651858.CD006219.pub4.
citation: Carrasco-Hernandez L, Jodar-Sanchez F, Nunez-Benjumea F, Moreno Conde J, Mesa Gonzalez M, Civit-Balcells A, Hors-Fraile S, Parra-Calderon CL, Bamidis PD, Ortega-Ruiz F. A Mobile Health Solution Complementing Psychopharmacology-Supported Smoking Cessation: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2020 Apr 27;8(4):e17530. doi: 10.2196/17530.
citation: Jodar-Sanchez F, Carrasco Hernandez L, Nunez-Benjumea FJ, Mesa Gonzalez MA, Moreno Conde J, Parra Calderon CL, Fernandez-Luque L, Hors-Fraile S, Civit A, Bamidis P, Ortega-Ruiz F. Using the Social-Local-Mobile App for Smoking Cessation in the SmokeFreeBrain Project: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2018 Dec 6;7(12):e12464. doi: 10.2196/12464.