A Mobile-phone Based Intervention to Support Smoking Cessation Among Chilean Women

NCT03191019 | Completed

• 2 other identifiers: 15-349FONIS SA15I20120
• Study Type: interventional
• Target: 309
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether a mobile-phone based intervention is effective in supporting smoking cessation among Chilean women

Conditions

Smoking Cessation

Keywords

Cell phones; Women

Outcome Measures

Primary Outcomes (1)

• Point prevalence of smoking abstinence at 4 weeks

  Self-reported no smoking in past 7 days at 4 weeks from quit date

  4 weeks

Secondary Outcomes (10)

• Continuous smoking abstinence at 4 weeks

  4 weeks

• Point prevalence of smoking abstinence at 3 months

  3 months

• Continuous smoking abstinence at 3 months

  3 months

• Point prevalence of smoking abstinence at 6 months

  6 months

• Biochemically verified continuous smoking abstinence at 6 months

  6 months

Study Arms (2)

Mobile-phone app for smoking cessation

EXPERIMENTAL

The intervention arm will receive a smoking cessation program based on a mobile-phone app. The program contains strategies to support smoking cessation, including motivational messages, tips on stress management, on how to ask support from friends and family, how to use distraction techniques and how to deal with cravings, lapses and early relapse. It also includes a saving calculator, a "help button" which provides extra messages in case of cravings and a "lapse button", which provides advice about what to do if the participant presents lapses or relapse after being abstinent at least 24 hours.

Behavioral: Mobile-phone app for smoking cessation

Control mobile-phone app

PLACEBO COMPARATOR

The control arm will receive a mobile-phone app which will send 1 message every two weeks thanking participants for taking part in the study, and encouraging them to stay in the study for the 6 month follow-up period.

Behavioral: Mobile-phone app for smoking cessation

Interventions

Mobile-phone app for smoking cessation BEHAVIORAL

Android App for smoking cessation

Control mobile-phone app; Mobile-phone app for smoking cessation

Eligibility Criteria

• Age: 18 Years - 44 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Smoker of at least 1 cigarette per day or at least 7 cigarettes per week in the last 6 months
• Willing to make a quit attempt in the next month
• Owns and uses an Android cell phone
• Lives in the Metropolitan Region and has no plans to move in the next year

You may not qualify if:

• Severe mental disability or inability to read or answer a telephone survey
• Screening positive for hazardous drinking behavior or active alcohol use disorder

Sponsors & Collaborators

• Pontificia Universidad Catolica de Chile: lead

Study Sites (1)

Centro de Salud Familiar Madre Teresa de Calcuta

Santiago, Other (Non U.s.), 8190985, Chile

Location

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Study Officials

• Claudia Bambs

  Pontificia Universidad Catolica de Chile

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Eligible participants will be randomized to the intervention group or control group using a computerized and automated process. An email will be automatically sent to the participants with the link to download the corresponding version of the mobile-phone app (intervention app or control app). Researchers who will gather data and those who will measure carbon monoxide in exhaled air will be masked to treatment allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two-arm, randomized clinical trial of a smoking cessation intervention based on a mobile-phone app. Participants will be randomly assigned to the intervention group or control group, in parallel for the duration of the study (6 months follow-up).

Study Record Dates

• First Submitted: June 14, 2017
• First Posted: June 19, 2017
• Study Start: November 6, 2017
• Primary Completion: July 22, 2018
• Study Completion: November 4, 2018
• Last Updated: November 18, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)