Tobacco Use CessationRESPREMONCT04207827
mHealth Intervention to Prevent Postpartum Smoking Relapse
A study testing xSmoker app and SMS in people with Tobacco Use Cessation and Pregnancy Related, run by Babes-Bolyai University at 1 site in Romania.
Trial summary
This project aims to develop an adapted and enhanced mHealth couple intervention to prevent post-partum smoking relapse. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Tobacco Use Cessation, Pregnancy Related
- What is being tested?
- xSmoker app and SMS
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteRomania
- Study dates
- 2 Jun 2018to 20 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An mHealth Intervention to Prevent Smoking Relapse After Pregnancy (RESPREMO)
This project aims to develop an adapted and enhanced mHealth couple intervention to prevent post-partum smoking relapse.
Read the 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.
- Conditions
- Tobacco Use Cessation, Pregnancy Related
- Being tested
- xSmoker app, SMS, Usual Care
- Keywords
- mHealth, smoking, postpartum
- Medical subject headings
- Tobacco Use Cessation, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
xSmoker appBehavioural
xSmoker - mHealth intervention consisted of using the app xSmoker
SMSBehavioural
Text messages with content based on the Motivation and Problem Solving approach and informed by our prior work.
Usual CareOther
Usual postnatal care
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: xSmoker app; Behavioral: SMS |
| Control | Other | Usual postnatal care Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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."
Measured: At 3 months post-birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2019
- Study start2 Jun 2018
- Primary completion15 Jan 2019
- Study completion20 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco Use CessationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Babes-Bolyai University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cristian Ioan Meghea, Babes-Bolyai University
- Investigators
- Cristian I Meghea, PhD, Principal investigator, Babes-Bolyai University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04207827
- Sponsor's protocol ID
- PN-III-P4-ID-PCE-2016-0632
- Acronym
- RESPREMO
- Status last verified
- Dec 2019
- First submitted
- 19 Dec 2019
- Last updated
- 24 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An mHealth Intervention to Prevent Smoking Relapse After Pregnancy (RESPREMO)
- ClinicalTrials.gov ID
- NCT04207827
- Acronym / sponsor ID
- RESPREMO / PN-III-P4-ID-PCE-2016-0632
- Conditions
- Tobacco Use Cessation, Pregnancy Related
- Keywords
- mHealth, smoking, postpartum
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Babes-Bolyai UniversityUniversity, hospital or other
- Study start
- 2 Jun 2018 (actual)
- Primary completion
- 15 Jan 2019 (actual)
- Study completion
- 20 Jul 2019 (actual)
- First posted
- 23 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| xSmoker app | Experimental | Behavioral: xSmoker appThe 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. |
| xSmoker app + SMSs | Experimental | Behavioral: xSmoker app, Behavioral: SMSThe 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. |
| Control | Other | Other: Usual CareUsual postnatal care |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| xSmoker appxSmoker - mHealth intervention consisted of using the app xSmoker | Behavioural | xSmoker app, xSmoker app + SMSs |
| SMSText messages with content based on the Motivation and Problem Solving approach and informed by our prior work. | Behavioural | xSmoker app + SMSs |
| Usual CareUsual postnatal care | Other | Control |
Primary outcome
Seven-day point prevalence abstinence (PPA)
Time frame: At 3 months post-birth
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)
Time frame: At 3 months post-birth
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."
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cristian I Meghea, PhD principal investigator
Babes-Bolyai University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing xSmoker app and SMS in people with Tobacco Use Cessation and Pregnancy Related, run by Babes-Bolyai University at 1 site in Romania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Romania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Seven-day point prevalence abstinence (PPA) (time frame: At 3 months post-birth). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2019.