Mobile Health Intervention for Family Smoking Cessation in Romania

Study Overview
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Brief Summary
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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.

Official Title
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Mobile Health Intervention for Family Smoking Cessation in Romania

Conditions
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Telemedicine: Smoking Cessation App Only, Telemedicine: Smoking Cessation Counseling, Telemedicine: App + Counseling, Usual Care

Intervention / Treatment
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* Behavioral: Smoke Free Together - App-only
* Behavioral: Smoke Free Together - Telemedicine counseling only
* Behavioral: Smoke Free Together - app + telemedicine


Participation Criteria
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Eligibility Criteria
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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: -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: App-only<br>The intervention will consist of participants will only use a smoking cessation app | Behavioral: Smoke Free Together - App-only<br>* Pregnant smokers and their life partners will use a smoking cessation app.<br>|
| Experimental: Telemedicine counseling only<br>The intervention will consist of participants will only use telemedicine counseling | Behavioral: Smoke Free Together - Telemedicine counseling only<br>* Pregnant smokers and their life partners will use telemedicine, real time video counseling on smoking cessation<br>|
| Experimental: App + telemedicine counseling<br>The intervention will consist of participants will only use a smoking cessation app + telemedicine counseling | Behavioral: Smoke Free Together - app + telemedicine<br>* Pregnant smokers and their life partners will use telemedicine and an app for smoking cessation<br>|
| No Intervention: Usual Care<br>The participants will continue with usual care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mHealth, Mobile health, Telehealth, Pregnancy, Tobacco, Cessation