Mobile Health Intervention for Family Smoking Cessation in Romania

Not Applicable

Completed

• Conditions: Telemedicine: App + Counseling; Telemedicine: Smoking Cessation Counseling; Telemedicine: Smoking Cessation App Only; Usual Care
• Interventions: Behavioral: Smoke Free Together - Telemedicine counseling only; Behavioral: Smoke Free Together - app + telemedicine; Behavioral: Smoke Free Together - App-only

• Registration Number: NCT03689140
• Lead Sponsor: Michigan State University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-09-19
• Study First Submitted QC: 2018-09-27
• Study First Posted: 2018-09-28
• Study Start: 2019-01-28
• Primary Completion: 2020-08-24
• Study Completion: 2020-08-24
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-14
• Last Update Posted: 2022-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 324

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Telemedicine counseling only	Smoke Free Together - Telemedicine counseling only	The intervention will consist of participants will only use telemedicine counseling
App + telemedicine counseling	Smoke Free Together - app + telemedicine	The intervention will consist of participants will only use a smoking cessation app + telemedicine counseling
App-only	Smoke Free Together - App-only	The intervention will consist of participants will only use a smoking cessation app

Primary Outcome Measures

Name	Time	Method
Percentage of women in each arm who stopped smoking, and who relapsed smoking postpartum	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.

Trial Locations

Locations (1)

Babes-Bolyai University; 🇷🇴 Cluj-Napoca, Cluj, Romania