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mHealth Intervention to Prevent Postpartum Smoking Relapse (RESPREMO)

Primary Purpose

Tobacco Use Cessation, Pregnancy Related

Status
Completed
Phase
Not Applicable
Locations
Romania
Study Type
Interventional
Intervention
xSmoker app
SMS
Usual Care
Sponsored by
Babes-Bolyai University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Tobacco Use Cessation focused on measuring mHealth, smoking, postpartum

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Babes-Bolyai University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Other

Arm Label

xSmoker app

xSmoker app + SMSs

Control

Arm Description

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.

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.

Usual postnatal care

Outcomes

Primary Outcome Measures

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.
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."

Secondary Outcome Measures

Full Information

First Posted
December 19, 2019
Last Updated
December 20, 2019
Sponsor
Babes-Bolyai University
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1. Study Identification

Unique Protocol Identification Number
NCT04207827
Brief Title
mHealth Intervention to Prevent Postpartum Smoking Relapse
Acronym
RESPREMO
Official Title
An mHealth Intervention to Prevent Smoking Relapse After Pregnancy (RESPREMO)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
June 2, 2018 (Actual)
Primary Completion Date
January 15, 2019 (Actual)
Study Completion Date
July 20, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Babes-Bolyai University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tobacco Use Cessation, Pregnancy Related
Keywords
mHealth, smoking, postpartum

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
xSmoker app
Arm Type
Experimental
Arm Description
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.
Arm Title
xSmoker app + SMSs
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
Other
Arm Description
Usual postnatal care
Intervention Type
Behavioral
Intervention Name(s)
xSmoker app
Intervention Description
xSmoker - mHealth intervention consisted of using the app xSmoker
Intervention Type
Behavioral
Intervention Name(s)
SMS
Intervention Description
Text messages with content based on the Motivation and Problem Solving approach and informed by our prior work.
Intervention Type
Other
Intervention Name(s)
Usual Care
Intervention Description
Usual postnatal care
Primary Outcome Measure Information:
Title
Seven-day point prevalence abstinence (PPA)
Description
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
Title
Prolonged abstinence (PA)
Description
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

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
The eligible participants were women who just gave birth and who gave up smoking during their pregnancy or 6 months prior to the pregnancy
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cristian I Meghea, PhD
Organizational Affiliation
Babes-Bolyai University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Babes-Bolyai University
City
Cluj-Napoca
State/Province
Cluj
Country
Romania

12. IPD Sharing Statement

Learn more about this trial

mHealth Intervention to Prevent Postpartum Smoking Relapse

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