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

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Status: Completed

Conditions: Health Behavior; Smoking Cessation; Lifestyle-related Condition

Treatments: Other: So-Lo-Mo; Behavioral: Psychological advice; Drug: Varenicline Pill; Drug: Bupropion Pill

Study type: Interventional

Funder types: Other

Identifiers

NCT03553173

SFB-APP_EC-2016-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 240 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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240 participants in 2 patient groups

Control

Active Comparator group

Description:

Subjects undergoing usual psycho-pharmacological treatment for smoking cessation. Prescribed treatments: * Bupropion pills + Psychological advice * Varenicline pills + Psychological advice

Treatment:

Drug: Bupropion Pill

Drug: Varenicline Pill

Behavioral: Psychological advice

Intervention

Experimental group

Description:

Subjects 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

Treatment:

Drug: Bupropion Pill

Drug: Varenicline Pill

Behavioral: Psychological advice

Other: So-Lo-Mo