Mobile Health Intervention for Family Smoking Cessation in Romania

Michigan State University

Status: Completed

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

Treatments: Behavioral: Smoke Free Together - Telemedicine counseling only; Behavioral: Smoke Free Together - App-only; Behavioral: Smoke Free Together - app + telemedicine

Study type: Interventional

Funder types: Other

Identifiers

NCT03689140

1R21TW010896

Details and patient eligibility

About

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.

Enrollment: 324 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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324 participants in 4 patient groups

App-only

Experimental group

Description:

The intervention will consist of participants will only use a smoking cessation app

Treatment:

Behavioral: Smoke Free Together - App-only

Telemedicine counseling only

Experimental group

Description:

The intervention will consist of participants will only use telemedicine counseling

Treatment:

Behavioral: Smoke Free Together - Telemedicine counseling only

App + telemedicine counseling

Experimental group

Description:

The intervention will consist of participants will only use a smoking cessation app + telemedicine counseling

Treatment:

Behavioral: Smoke Free Together - app + telemedicine

Usual Care

No Intervention group

Description:

The participants will continue with usual care