Telemedicine: App + Counseling, Telemedicine: Smoking Cessation App Only, Telemedicine: Smoking Cessation Counseling, Usual Care
Conditions
Keywords
mHealth, Mobile health, Telehealth, Pregnancy, Tobacco, Cessation
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.
Interventions
BEHAVIORALSmoke Free Together - App-only
Pregnant smokers and their life partners will use a smoking cessation app.
BEHAVIORALSmoke Free Together - Telemedicine counseling only
Pregnant smokers and their life partners will use telemedicine, real time video counseling on smoking cessation
BEHAVIORALSmoke Free Together - app + telemedicine
Pregnant smokers and their life partners will use telemedicine and an app for smoking cessation
Sponsors
Babes-Bolyai University
University of Michigan
Wake Forest University Health Sciences
Michigan State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Romania
Outcome results
None listed