Effectiveness of an App for Tobacco Cessation in Pregnant Women (TOBBGEST)

Summary

Background: Tobacco use during pregnancy is one of the most modifiable causes of morbidity and mortality for both pregnant women and their fetus. Despite the fact that smoking among pregnant has decreased in recent years, smoking continues to be a major public health problem.

Hypothesis / Research question: The use of new technologies such as applications (apps) for mobile devices designed with a gamification strategy (understood as an incentive through play) could help women to quit smoking during pregnancy and in the long term. A structured App-based intervention using gamification adapted to pregnant women will decrease smoking prevalence in this population.

Objectives: To evaluate the effectiveness of an intervention against tobacco in pregnant women based on an app for tobacco abstinence. Specific objectives: 1) To determine the effectiveness of the intervention on smoking cessation during pregnancy, 2) Determine the effectiveness of the intervention in in the long term and 3) To determine the impact of the intervention to reduce smoking in pregnant women who continue smoking.

Design: Randomized, multicentre community intervention trial

Setting: Sexual and Reproductive Health Care Services of the Camp de Tarragona and Central Catalonia Primary Care Centres.

Intervention: the participants will have the usual clinical practice intervention and the intervention group (IG) will also have access to an app based on gamification, verified by coximetry during the follow-up, and with a cotinine test at the end.

Analysis: of groups "by intention to treat", abstinence rates will be compared and the determining factors will be evaluated using multivariate statistics.

Expected results: smoking cessation in the IG will be \> 5%, compared to normal practice.

Applicability and Relevance: It promotes activities aimed to reduce tobacco consumption in the general population, and especially in women, in order to decrease comorbidity associated with long-term smoking, which will lead to a reduction in tobacco-related diseases in the whole population.

Conditions

• Pregnant Women

Interventions

DEVICE

Gestob App

Gestop App is a mobile app that aims to help pregnant women quit smoking through gamification. It also allows you to obtain information about tobacco and pregnancy.

Sponsors & Collaborators

• Institut Català de la Salut

  collaborator OTHER

• Instituto de Salud Carlos III

  collaborator OTHER_GOV

• Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

  lead OTHER

Principal Investigators

• Cristina Rey-Reñones, PhD · IDIAP JORDI GOL

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

50 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-02-01

Primary Completion

2025-09-30

Completion

2026-05-30

Countries

• Spain

Study Locations