NCT05222958

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
0mo left

Started Feb 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress99%
Feb 2023May 2026

First Submitted

Initial submission to the registry

January 24, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 3, 2022

Completed
12 months until next milestone

Study Start

First participant enrolled

February 1, 2023

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2025

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2026

Expected
Last Updated

September 19, 2024

Status Verified

March 1, 2024

Enrollment Period

2.7 years

First QC Date

January 24, 2022

Last Update Submit

September 12, 2024

Conditions

Pregnant Women

Keywords

TobaccoPregnant womenGamificationTelemedicine

Outcome Measures

Primary Outcomes (1)

  • Smoking cessation

    Women who have stopped smoking during pregnancy will be scheduled to visit their health centre 12 months after the intervention to find out about their relationship with smoking.

    1 year

Secondary Outcomes (1)

  • Verification of smoking abstinence

    1 year

Study Arms (2)

Experimental:

EXPERIMENTAL

The intervention consists of using a smoking cessation app. Patients assigned to the intervention group will be given the access code to the Gestobb App and advice on how to use it.

Device: Gestob App

No intervention

NO INTERVENTION

Patients in the control group will continue their follow-up visits at ASSIR and will be offered smoking cessation treatment following standard practice protocols.

Interventions

Gestob AppDEVICE

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.

Experimental:

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPregnant women
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Pregnant women smokers (report having smoked sporadically or daily in the last 30 days(\*)) over 18 years of age,
  • Follow-up of pregnancy in the ASSIR in Camp de Tarragona and Barcelona of the ICS,
  • Having a mobile device with Android or iOS operating system and data connection,
  • Having skills on the use of Apps and willingness to use them (#).
  • (\*) Active smoking is defined as daily or occasional smoking in the last month, regardless of the amount smoked.
  • (#) It is understood that you have skills on the use of Apps and willingness to use them if you answer affirmatively to the following questions: Have you downloaded any application on your mobile?, Would you install an application to help you quit smoking on your mobile?, Have you participated in any chat group?, and Have you played any game with your mobile device? (criteria to ensure the usability of the intervention tool).

You may not qualify if:

  • Having participated in a smoking cessation study within the last 12 months,
  • Psychiatric history that prevents or limits follow-up of the study,
  • Inability to follow up for any reason,
  • Express refusal of the patient to continue in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IDIAP Jordi Gol

Barcelona, Barcelona, 08007, Spain

RECRUITING

Related Publications (2)

  • Agras-Guardia M, Martinez-Torres S, Satue E, Granado-Font E, Palleja-Millan M, Patricio D, Leiva M, Rey-Renones C, Martin-Lujan F. Experiences of smoking and tobacco use during pregnancy: A qualitative study protocol. PLoS One. 2024 Aug 9;19(8):e0308781. doi: 10.1371/journal.pone.0308781. eCollection 2024.

    PMID: 39121101DERIVED

  • Agras-Guardia M, Martinez-Torres S, Granado-Font E, Palleja-Millan M, Villalobos F, Patricio D, Ruiz F, Marin-Gomez FX, Duch J, Rey-Renones C, Martin-Lujan F. Effectiveness of an App for tobacco cessation in pregnant smokers (TOBBGEST): study protocol. BMC Pregnancy Childbirth. 2022 Dec 13;22(1):933. doi: 10.1186/s12884-022-05250-5.

    PMID: 36514020DERIVED

Study Officials

  • Cristina Rey-Reñones, PhD

    Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Cristina Rey-Reñones, PhD

CONTACT

34977778515crey.tgn.ics@gencat.cat

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 24, 2022

First Posted

February 3, 2022

Study Start

February 1, 2023

Primary Completion

September 30, 2025

Study Completion (Estimated)

May 30, 2026

Last Updated

September 19, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will share

not yet decided as future studies are being considered and may be considered

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
3 years
Access Criteria
The data will be entered on the IDIAp J Gol institution platform
More information

Locations

ES(1)