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mHealth Intervention to Prevent Postpartum Smoking Relapse

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04207827
Acronym
RESPREMO
Enrollment
75
Registered
2019-12-23
Start date
2018-06-02
Completion date
2019-07-20
Last updated
2019-12-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnancy Related, Tobacco Use Cessation

Keywords

mHealth, smoking, postpartum

Brief summary

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

Detailed description

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.

Interventions

BEHAVIORALxSmoker app

xSmoker - mHealth intervention consisted of using the app xSmoker

BEHAVIORALSMS

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

OTHERUsual Care

Usual postnatal care

Sponsors

Babes-Bolyai University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Seven-day point prevalence abstinence (PPA)At 3 months post-birthPPA, 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.
Prolonged abstinence (PA)At 3 months post-birthPA 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.

Countries

Romania

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026