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Mobile Health Intervention for Family Smoking Cessation in Romania

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03689140
Recruitment Status : Recruiting
First Posted : September 28, 2018
Last Update Posted : April 19, 2019
Sponsor:
Collaborators:
Babes-Bolyai University
University of Michigan
Wake Forest University Health Sciences
Information provided by (Responsible Party):
Cristian Meghea, Michigan State University

Brief Summary:
The objectives of this study are to determine in a randomized controlled trial (RCT) whether a 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.

Condition or disease Intervention/treatment Phase
Telemedicine: Smoking Cessation App Only Telemedicine: Smoking Cessation Counseling Telemedicine: App + Counseling Usual Care Behavioral: Smoke Free Together - App-only Behavioral: Smoke Free Together - Telemedicine counseling only Behavioral: Smoke Free Together - app + telemedicine Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Mobile Health Intervention for Family Smoking Cessation in Romania
Actual Study Start Date : January 28, 2019
Estimated Primary Completion Date : July 1, 2020
Estimated Study Completion Date : July 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: App-only
The intervention will consist of participants will only use a smoking cessation app
Behavioral: Smoke Free Together - App-only
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
Behavioral: Smoke Free Together - Telemedicine counseling only
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
Behavioral: Smoke Free Together - app + telemedicine
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



Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03689140


Contacts
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Contact: Cristian I Meghea, PhD 2487161043 meghea@msu.edu

Locations
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Romania
Babes-Bolyai University Recruiting
Cluj-Napoca, Cluj, Romania, 400301
Contact: Alexandra Onisor, MA    +40752721909    alexandra.onisor@publichealth.ro   
Sponsors and Collaborators
Michigan State University
Babes-Bolyai University
University of Michigan
Wake Forest University Health Sciences
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Responsible Party: Cristian Meghea, Assistant Professor, Michigan State University
ClinicalTrials.gov Identifier: NCT03689140    
Other Study ID Numbers: 1R21TW010896 ( U.S. NIH Grant/Contract )
First Posted: September 28, 2018    Key Record Dates
Last Update Posted: April 19, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Cristian Meghea, Michigan State University:
mHealth
Mobile health
Telehealth
Pregnancy
Tobacco
Cessation