Mobile Health Intervention for Family Smoking Cessation in Romania

NCT ID: NCT03689140

Last Updated: 2022-04-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

324 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-28

Study Completion Date

2020-08-24

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.

Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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App-only

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

Group Type EXPERIMENTAL

Smoke Free Together - App-only

Intervention Type BEHAVIORAL

Pregnant smokers and their life partners will use a smoking cessation app.

Telemedicine counseling only

The intervention will consist of participants will only use telemedicine counseling

Group Type EXPERIMENTAL

Smoke Free Together - Telemedicine counseling only

Intervention Type BEHAVIORAL

Pregnant smokers and their life partners will use telemedicine, real time video counseling on smoking cessation

App + telemedicine counseling

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

Group Type EXPERIMENTAL

Smoke Free Together - app + telemedicine

Intervention Type BEHAVIORAL

Pregnant smokers and their life partners will use telemedicine and an app for smoking cessation

Usual Care

The participants will continue with usual care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Smoke Free Together - App-only

Pregnant smokers and their life partners will use a smoking cessation app.

Intervention Type BEHAVIORAL

Smoke Free Together - Telemedicine counseling only

Pregnant smokers and their life partners will use telemedicine, real time video counseling on smoking cessation

Intervention Type BEHAVIORAL

Smoke Free Together - app + telemedicine

Pregnant smokers and their life partners will use telemedicine and an app for smoking cessation

Intervention Type BEHAVIORAL

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

\-
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Babes-Bolyai University

OTHER

Sponsor Role collaborator

University of Michigan

OTHER

Sponsor Role collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role collaborator

Michigan State University

OTHER

Sponsor Role lead

Responsible Party

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Cristian Meghea

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Babes-Bolyai University

Cluj-Napoca, Cluj, Romania

Site Status

Countries

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Romania

Provided Documents

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Document Type: Informed Consent Form: Informed consent for women

View Document

Document Type: Informed Consent Form: Informed consent for partners

View Document

Other Identifiers

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1R21TW010896

Identifier Type: NIH

Identifier Source: org_study_id

View Link

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