mHealth Intervention to Prevent Postpartum Smoking Relapse

N/ACompletedNCT04207827

Babes-Bolyai University75 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

Conditions

Tobacco Use Cessation Pregnancy Related

Interventions

xSmoker appBEHAVIORAL

xSmoker - mHealth intervention consisted of using the app xSmoker

SMSBEHAVIORAL

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

Usual CareOTHER

Usual postnatal care

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Babes-Bolyai University

Cluj-Napoca, Cluj, Romania

Outcomes

Primary Outcomes

Seven-day point prevalence abstinence (PPA)

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.

Time frame: At 3 months post-birth

Prolonged abstinence (PA)

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."

Time frame: At 3 months post-birth

Data from ClinicalTrials.gov

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