Mobile Health Intervention for Family Smoking Cessation in Romania
1 other identifier
interventional
324
1 country
1
Brief Summary
The objectives of this study are to determine in a randomized controlled trial (RCT) whether a mobile health (mHealth) couples intervention shows promise in increasing smoking cessation among pregnant couples who smoke and to build mHealth research capacity in Romania. The intervention will be novel in its use of the unique functionality of smartphones, its emphasis on the dyadic efficacy for smoking cessation, and the focus on pregnant couples. Our aims are to (1) Test the implementation feasibility, acceptability, and initial efficacy of a culturally-adapted mHealth smoking cessation intervention among couples during pregnancy and postpartum in Romania. (2) Develop mHealth research capacity by enhancing individual and institutional research capabilities in Romania and expanding the existing international research network.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 19, 2018
CompletedFirst Posted
Study publicly available on registry
September 28, 2018
CompletedStudy Start
First participant enrolled
January 28, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 24, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
August 24, 2020
CompletedApril 21, 2022
April 1, 2022
1.6 years
September 19, 2018
April 14, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of women in each arm who stopped smoking, and who relapsed smoking postpartum
The primary outcomes are maternal pregnancy smoking cessation and postnatal relapse. Maternal smoking status will be biochemically verified at the final follow-up based on salivary cotinine obtained by mail.
Change from smoking at baseline to quitting assessed at 3 months after the intervention is completed
Study Arms (4)
App-only
EXPERIMENTALThe intervention will consist of participants will only use a smoking cessation app
Telemedicine counseling only
EXPERIMENTALThe intervention will consist of participants will only use telemedicine counseling
App + telemedicine counseling
EXPERIMENTALThe intervention will consist of participants will only use a smoking cessation app + telemedicine counseling
Usual Care
NO INTERVENTIONThe participants will continue with usual care
Interventions
Pregnant smokers and their life partners will use a smoking cessation app.
Pregnant smokers and their life partners will use telemedicine, real time video counseling on smoking cessation
Pregnant smokers and their life partners will use telemedicine and an app for smoking cessation
Eligibility Criteria
You may qualify if:
- pregnant smokers in the 2nd or 3rd pregnancy trimester and their partners.
- years or older
- married or in a stable relationship
- owns and uses an Android smartphone with broadband internet connection
- willing to have the partner contacted for participation.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Michigan State Universitylead
- Babes-Bolyai Universitycollaborator
- University of Michigancollaborator
- Wake Forest University Health Sciencescollaborator
Study Sites (1)
Babes-Bolyai University
Cluj-Napoca, Cluj, 400301, Romania
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
September 19, 2018
First Posted
September 28, 2018
Study Start
January 28, 2019
Primary Completion
August 24, 2020
Study Completion
August 24, 2020
Last Updated
April 21, 2022
Record last verified: 2022-04
Data Sharing
- IPD Sharing
- Will not share