mHealth Intervention to Prevent Postpartum Smoking Relapse

Pregnancy Related Clinical Trial

— RESPREMO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04207827
• Other study ID #: PN-III-P4-ID-PCE-2016-0632
• Status: Completed
• Phase: N/A
• Start date: June 2, 2018
• Est. completion date: July 20, 2019

Study information

• Verified date: December 2019
• Source: Babes-Bolyai University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: July 20, 2019
• Est. primary completion date: January 15, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pregnancy Related
• Recurrence
• Tobacco Use Cessation

Intervention

Behavioral:
• xSmoker app
xSmoker - mHealth intervention consisted of using the app xSmoker
• SMS
Text messages with content based on the Motivation and Problem Solving approach and informed by our prior work.

Other:
• Usual Care
Usual postnatal care

Locations

Country	Name	City	State
Romania	Babes-Bolyai University	Cluj-Napoca	Cluj

Sponsors (1)

Lead Sponsor	Collaborator
Babes-Bolyai University

Country where clinical trial is conducted

Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	At 3 months post-birth
Primary	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."	At 3 months post-birth

External Links

•   The project's website