- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03689140
Mobile Health Intervention for Family Smoking Cessation in Romania
April 14, 2022 updated by: Cristian Meghea, Michigan State University
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.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
324
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Cluj
-
Cluj-Napoca, Cluj, Romania, 400301
- Babeș-Bolyai University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- pregnant smokers in the 2nd or 3rd pregnancy trimester and their partners.
- 18 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.
Exclusion Criteria:
-
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: App-only
The intervention will consist of participants will only use a smoking cessation app
|
Pregnant smokers and their life partners will use a smoking cessation app.
|
Experimental: Telemedicine counseling only
The intervention will consist of participants will only use telemedicine counseling
|
Pregnant smokers and their life partners will use telemedicine, real time video counseling on smoking cessation
|
Experimental: App + telemedicine counseling
The intervention will consist of participants will only use a smoking cessation app + telemedicine counseling
|
Pregnant smokers and their life partners will use telemedicine and an app for smoking cessation
|
No Intervention: Usual Care
The participants will continue with usual care
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of women in each arm who stopped smoking, and who relapsed smoking postpartum
Time Frame: Change from smoking at baseline to quitting assessed at 3 months after the intervention is completed
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 28, 2019
Primary Completion (Actual)
August 24, 2020
Study Completion (Actual)
August 24, 2020
Study Registration Dates
First Submitted
September 19, 2018
First Submitted That Met QC Criteria
September 27, 2018
First Posted (Actual)
September 28, 2018
Study Record Updates
Last Update Posted (Actual)
April 21, 2022
Last Update Submitted That Met QC Criteria
April 14, 2022
Last Verified
April 1, 2022
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 1R21TW010896 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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