NCT02666482

Brief Summary

The Institute for International Internet Interventions for Health (i4Health) at Palo Alto University proposes to develop digital tools specifically designed to help low income English-speaking and Spanish-speaking smokers to quit. The investigators aim to test whether a mobile-based digital intervention designed with systematic input from low-income English- and Spanish-speaking smokers from a public sector health care system can significantly improve its acceptability, utilization, and effectiveness. Using human-centered development methods, the project will involve low-income patients of the San Francisco Health Network in the design of a web app/text messaging tool. The investigators will also use participants input to improve the recruitment and dissemination strategies. i4Health will join forces with the Center for Behavioral Intervention Technologies (CBITs) at Northwestern University to iteratively develop successive versions of the digital interventions informed by our human-centered approach. The full study involves 4 successive outcome studies testing the effectiveness of the Stop Smoking San Francisco web app. The first three are single-group non-randomized pre-post studies with 1, 2, and 3-month follow-ups. These will test gradually improved versions of the app. The fourth study will involve a randomized trial comparing the initial version (the baseline version) of the web app to the final version of the web app, to determine if the final version is significantly better than the baseline version in terms of increased utilization and abstinence rates. To join this study, go to: https://stopsmokingsf.org

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,107

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 12, 2016

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

January 21, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 28, 2016

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2018

Completed
Last Updated

November 15, 2018

Status Verified

November 1, 2018

Enrollment Period

2.4 years

First QC Date

January 21, 2016

Last Update Submit

November 13, 2018

Conditions

Smoking Cessation

Keywords

smokingstop smokingtobacco use cessation

Outcome Measures

Primary Outcomes (1)

  • 7-day Quit rate

    1 Month

Secondary Outcomes (1)

  • Utilization of web app: Number of times web app screens are accessed and data entered

    1 month

Study Arms (1)

Stop Smoking SF Web App - baseline

EXPERIMENTAL

Online Study 1 will test the data gathering aspects of the proposed web app using a baseline, "usual care" intervention consisting of a static smoking cessation guide, the Guía para Dejar de Fumar, tested in printed form in the Muñoz et al. (1997) study. The print version of the guide yielded an 11% quit rate at 3 months. The investigators will utilize the content of the guide as the main element of the baseline app, so it will serve to estimate baseline utilization and quit rates when this already tested intervention is provided in a web app format. Participants can join the study online by going to: https://stopsmokingsf.org

Behavioral: Stop Smoking SF Web App - baseline

Interventions

Stop Smoking SF Web App - baselineBEHAVIORAL

Smoking cessation web app in Spanish and English. Accessible online at no charge.

Stop Smoking SF Web App - baseline

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • English speaking (ES) and Spanish speaking (SS)

You may not qualify if:

  • Not a smoker

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Palo Alto University

Palo Alto, California, 94304, United States

Location

Related Publications (3)

  • Munoz RF, Marin BV, Posner SF, Perez-Stable EJ. Mood management mail intervention increases abstinence rates for Spanish-speaking Latino smokers. Am J Community Psychol. 1997 Jun;25(3):325-43. doi: 10.1023/a:1024676626955.

    PMID: 9332966BACKGROUND

  • Muñoz, R. F., Bunge, E. L., Chen, K., Schueller, S. M., Bravin, J. I., Shaughnessy, E. A., & Pérez-Stable, E. J. (2015). Massive Open Online Interventions: A novel model for delivering behavioral-health services worldwide. Clinical Psychological Science. Advance online publication. doi: 10.1177/2167702615583840

    BACKGROUND

  • Munoz RF, Bunge EL, Barrera AZ, Wickham RE, Lee J. Using Behavioral Intervention Technologies to Help Low-Income and Latino Smokers Quit: Protocol of a Randomized Controlled Trial. JMIR Res Protoc. 2016 Jun 14;5(2):e127. doi: 10.2196/resprot.5355.

    PMID: 27302623DERIVED

MeSH Terms

Conditions

Smoking CessationSmokingTobacco Use Cessation

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Study Officials

  • Ricardo F. Munoz, Ph.D.

    Director, i4Health, Palo Alto University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 21, 2016

First Posted

January 28, 2016

Study Start

January 12, 2016

Primary Completion

June 15, 2018

Study Completion

June 15, 2018

Last Updated

November 15, 2018

Record last verified: 2018-11

Locations

US(1)