AzTrials
AzTrials

Smoking CessationSo-Lo-MoNCT03553173

So-Lo-Mo Intervention Applied to the Smoking Cessation Process

A study testing So-Lo-Mo, Psychological advice and Bupropion Pill in people with Smoking Cessation and Health Behavior, run by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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)… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
So-Lo-Mo, Psychological advice and Bupropion Pill
Could I receive a placebo?
No, everyone receives an active treatment
How many people
240 participants
Where
No sites listed yet
Study dates
24 Oct 2016to 24 Oct 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

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

About this study

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.

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.

Read the 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.
Being tested
So-Lo-Mo, Psychological advice, Bupropion Pill, Varenicline Pill
Keywords
Smoking Cessation, App, Decision Support System
Medical subject headings
Smoking Cessation, Health Behavior, Mental Disorders, Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • So-Lo-MoOther

    Also called SoLoMo

    So-Lo-Mo is an innovative intervention based on mobile technologies and its capacity to trigger behavioral changes. In this sense, the App is a complement to pharmacological therapies to quit smoking providing personalised motivational messages, physical activity monitoring, lifestyle advices and distractions (mini-games) to help pass the cravings. The main objective of this App is to improve patient's adherence to the smoking cessation process making use of behavioral techniques in the form of motivational messages and/or Short Message Service (SMS).

  • Psychological adviceBehavioural

    Also called Behavioral

    Provision of information about smoking and smoking cessation process, as well as supporting behavioral changes through the provision of new skills and strategies. The most used methods are the motivational interview and the cognitive-behavioral therapy

  • Bupropion PillDrug

    Also called Bupropion

    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.

  • Varenicline PillDrug

    Also called Varenicline

    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.

Study groups in NCT03553173
Study groupRoleWhat they receive
ControlActive comparatorSubjects undergoing usual psycho-pharmacological treatment for smoking cessation. Prescribed treatments: * Bupropion pills + Psychological advice * Varenicline pills + Psychological advice
Receives: Behavioral: Psychological advice; Drug: Bupropion Pill; Drug: Varenicline Pill
InterventionExperimentalSubjects undergoing usual psycho-pharmacological treatment for smoking cessation plus a smart phone App. Prescribed treatments: * Bupropion pills + Psychological advice + So-Lo-Mo * Varenicline pills + Psychological advice + So-Lo-Mo
Receives: Other: So-Lo-Mo; Behavioral: Psychological advice; Drug: Bupropion Pill; Drug: Varenicline Pill

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Efficacy: Smoking abstinence rate

    Smoking abstinence rate at 1 year measured by means of exhaled Carbon Monoxide (CO) and urinary cotinine tests. Subjects with cotinine concentrations >200 ng/ml or CO >6 ppm will be considered as smokers.

    Measured: 1 year

  2. Efficiency: Incremental Cost-Effectiveness Ratio

    Expressed in terms of Incremental Cost-Effectiveness Ratio (ICER), calculated by dividing the difference in total costs between the intervention group and the control group by the difference in Quality-Adjusted Life Year (QALY) between both groups. Costs associated to control and intervention groups will include healthcare resources utilization measured in terms of specialist consultations related to the smoking cessation process. Costs of pharmacological treatment and time employed by healthcare professionals during the design phase will also be taken into account. Benefit for patients will be expressed in terms of QALY. EuroQol-5D-5L questionnaire will be used to estimate QALY.

    Measured: 1 year

Secondary outcomes (3)

  1. Incidence of Treatment-Related Adverse Events [Safety]

    To monitor usual pharmacological therapies (bupropion and varenicline) in order to gather the incidence of related adverse events reported. Safety will be measured as the number of adverse events related to pharmacological therapies. The following adverse events have been identified related to each pharmacological therapy:

    Varenicline: Nausea, vomit, headache, insomnia, abnormal dreams, constipation and flatulence.

    Bupropion: insomnia, headache, dryness in the mouth, alteration of taste, skin reactions, convulsions, cardiovascular side effects and severe skin reactions.

    Measured: 1 year

  2. International Physical Activity Questionnaire (IPAQ27) score [Physical activity]

    Physical activity will be measured in terms of the International Physical Activity Questionnaire (IPAQ27) score calculation at baseline (first evaluation in the study) and at the end of the intervention (after 1 year of follow-up). The result is expressed as metabolic equivalent (MET)-minutes per week. Interpretation:

    • Low: Individuals who not meet criteria for categories 2 or 3 are considered 'low'
    • Moderate: 3 or more days of vigorous-intensity activity of at least 20 minutes per day OR 5 or more days of moderate-intensity activity and/or walking of at least 30 minutes per day OR 5 or more days of any combination of walking, moderate-intensity or vigorous intensity activities achieving a minimum Total physical activity of at least 600 MET-minutes/week
    • High: vigorous-intensity activity on at least 3 days achieving a minimum Total physical activity of at least 1500 MET-minutes/week

    Measured: From baseline (first evaluation in the study) to 1 year after

  3. Body Mass Index (BMI) in kg/m^2 [Healthy lifestyle]

    Healthy lifestyle will be measured in terms of the subject's BMI (weight in kg / height in m^2) at baseline (first evaluation in the study) and at the end of the intervention (after 1 year of follow-up).

    Measured: From baseline (first evaluation in the study) to 1 year after

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jun 2018
  2. Study start24 Oct 2016
  3. Primary completion24 Oct 2018
  4. Study completion24 Oct 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
A randomized open-label parallel-group trial.
Masking
None (open label)
Enrolment
240 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03553173
Sponsor's protocol ID
SFB-APP_EC-2016-01
Acronym
So-Lo-Mo
Status last verified
Dec 2018
First submitted
2 May 2018
Last updated
4 Dec 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 34611902

  • 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.

    PubMed 32338624

  • 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.

    PubMed 30522992

Questions about this trial

What is this clinical trial studying?

A study testing So-Lo-Mo, Psychological advice and Bupropion Pill in people with Smoking Cessation and Health Behavior, run by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Efficacy: Smoking abstinence rate (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03553173, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2018.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in