Skip to main content
OpenTrials
Completed

NCT Number: NCT04207827

mHealth Intervention to Prevent Postpartum Smoking Relapse

This project aims to develop an adapted and enhanced mHealth couple intervention to prevent post-partum smoking relapse.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Tobacco Use Cessation Behavior Health Behavior Pregnancy Related Smoking

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Babes-Bolyai University

Cluj-Napoca, Cluj, Romania

About this study

The main goal of this project is to develop, implement, and disseminate effective and sustainable interventions to prevent and reduce smoking in families over their reproductive life span. So, the purpose of this project is to adapt, enhance, and test the implementation feasibility and efficacy of an evidence-based pregnancy and postnatal smoking relapse pilot mHealth intervention. The scientific relevance of this research project is given by: 1) testing a cultural-adapted version of the iCoach mobile application for the prevention of smoking uptake after birth. 2) The cultural adaptation will be obtained based on the existing literature regarding the adaptation of preventive interventions for substance use. 3) The iCoach app intervention is enhanced with SMS-delivered content addressing the dyadic efficacy for smoking cessation aiming to improve both partners' skills to work together as a team to prevent smoking uptake after birth.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • older than 18 years
  • gave up smoking 6 months before or during pregnancy
  • owns a smartphone
  • has a stable partner/husband
  • offers the partner's contact data
  • signs the informed consent
  • CO level (ppm) below 4

Exclusion criteria

  • younger than 18 years
  • smoker
  • does not own a smartphone
  • does not have a stable partner/husband
  • refuses to offer the partner's contact data
  • refuses to sign the informed consent
  • refuses the CO level measurement or the CO level (ppm) is above 4

Treatment and study plan

xSmoker app

Behavioral

xSmoker - mHealth intervention consisted of using the app xSmoker

SMS

Behavioral

Text messages with content based on the Motivation and Problem Solving approach and informed by our prior work.

Usual Care

Other

Usual postnatal care

Primary outcomes

  1. Seven-day point prevalence abstinence (PPA)

    Time frame: At 3 months post-birth

    PPA, participants who reported 'no smoking, not even a puff' in the previous 7 days are mailed a saliva cotinine test and asked to send at least one photo of the completed test. Those with a salivary cotinine <10 ng/mL, were considered confirmed nonsmokers.

  2. Prolonged abstinence (PA)

    Time frame: At 3 months post-birth

    PA was defined based on the question "Have you smoked tobacco cigarettes over the past 6 months", with PA failure determined by the answers "Yes, I smoked, but never a whole cigarette," "Yes, I smoked cigarettes, but only occasionally," or "Yes, I smoked cigarettes daily for a period (or periods) of time."

Sponsors and collaborators

Lead sponsor

Babes-Bolyai University

Other

Registry information

Official study title

An mHealth Intervention to Prevent Smoking Relapse After Pregnancy (RESPREMO)

Acronym: RESPREMO

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Dec 23, 2019
Registry last updated
Dec 24, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.