Mobile Health Intervention for Family Smoking Cessation in Romania

Usual Care Clinical Trial

Official title:

Mobile Health Intervention for Family Smoking Cessation in Romania

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03689140
• Other study ID #: 1R21TW010896
• Status: Completed
• Phase: N/A
• Start date: January 28, 2019
• Est. completion date: August 24, 2020

Study information

• Verified date: April 2022
• Source: Michigan State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 324
• Est. completion date: August 24, 2020
• Est. primary completion date: August 24, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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: -

Related Conditions & MeSH terms

• Telemedicine: App + Counseling
• Telemedicine: Smoking Cessation App Only
• Telemedicine: Smoking Cessation Counseling
• Usual Care

Intervention

Behavioral:
• Smoke Free Together - App-only
Pregnant smokers and their life partners will use a smoking cessation app.
• Smoke Free Together - Telemedicine counseling only
Pregnant smokers and their life partners will use telemedicine, real time video counseling on smoking cessation
• Smoke Free Together - app + telemedicine
Pregnant smokers and their life partners will use telemedicine and an app for smoking cessation

Locations

Country	Name	City	State
Romania	Babes-Bolyai University	Cluj-Napoca	Cluj

Sponsors (4)

Lead Sponsor	Collaborator
Michigan State University	Babes-Bolyai University, University of Michigan, Wake Forest University Health Sciences

Country where clinical trial is conducted

Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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