mHealth Intervention to Prevent Postpartum Smoking Relapse

NCT04207827 | Completed

• 1 other identifier: PN-III-P4-ID-PCE-2016-0632
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Tobacco Use Cessation; Pregnancy Related

Keywords

mHealth; smoking; postpartum

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (3)

xSmoker app

EXPERIMENTAL

The xSmoker app was developed with European Commission funding. xSmoker is a digital health coaching mobile app that helps individuals stop smoking and remain smoke free. The initial version of the xSmoker application was received from the developers and translated into Romanian by the research team. The content has been divided into three main sections: "Daily Tips" (approximately 630 items), which includes information on the beneficial effects of quitting smoking, "Panic Tips" (approximately 100 items), which can be accessed at that time when risk of smoking relapse is high, as well as a section called "Library" (about 120 items), where detailed information on the topics included in the first two sections is provided.

Behavioral: xSmoker app

xSmoker app + SMSs

EXPERIMENTAL

The xSmoker app + phone text messages with content based on the Motivation and Problem Solving approach and informed by our prior work. The investigators developed six categories of messages sent to participants: (1)Importance and trust, (2)Fear of relapse, (3)Partner support, (4)Breastfeeding, (5)The need to smoke, and (6)Relapse. Four major objectives were established based on the content of the SMS text messages, with the help of the literature: (1)supporting motivation, (2)supporting self-efficacy, (3)supporting dyadic effectiveness, and (4)developing problem-solving skills. The messages were delivered using Textit, a platform for visually building interactive SMS applications (htpps://textit.in). All the messages were uploaded in the platform and different flows and sub-flows were created for every day of the intervention to automatize the process of SMS delivery. A combination of trigger words and skip patterns was used in order to tailor the messages.

Behavioral: xSmoker app; Behavioral: SMS

Control

OTHER

Usual postnatal care

Other: Usual Care

Interventions

xSmoker app BEHAVIORAL

xSmoker - mHealth intervention consisted of using the app xSmoker

xSmoker app; xSmoker app + SMSs

SMS BEHAVIORAL

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

xSmoker app + SMSs

Usual Care OTHER

Usual postnatal care

Control

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: The eligible participants were women who just gave birth and who gave up smoking during their pregnancy or 6 months prior to the pregnancy
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Babes-Bolyai University: lead

Study Sites (1)

Babes-Bolyai University

Cluj-Napoca, Cluj, Romania

Location

Related Links

• The project's website

MeSH Terms

Conditions

Tobacco Use Cessation; Smoking

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Study Officials

• Cristian I Meghea, PhD

  Babes-Bolyai University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Project Director

Study Record Dates

• First Submitted: December 19, 2019
• First Posted: December 23, 2019
• Study Start: June 2, 2018
• Primary Completion: January 15, 2019
• Study Completion: July 20, 2019
• Last Updated: December 24, 2019

Record last verified: 2019-12

Locations

RO (1)