- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05278481
Latinos Kick Buts: Mobile Engagement and Cessation Support for Latino Smokers
June 8, 2022 updated by: Paula Cupertino, University of Rochester
Latinos Kick Buts: Mobile Engagement and Cessation Support for Latino Smokers Pilot Study
Latino Kick Buts (LKB) is a smoking cessation treatment program available to patients identified as smokers at the University of Rochester Medical Center.
Latino Kick Buts smoking cessation mobile program encompasses two integrated components: (1) a 12-week text messaging counseling program with interactive capabilities; and (2) pharmacotherapy support (provision of nicotine replacement therapy at no cost).
LKB utilization among Latino smokers remains minimal.
The aim of this pilot study is to identify types of text message that are more effective to enrolling Latino smokers in the LKB.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
- Behavioral: Reward Message with standard introduction
- Behavioral: Reward Message with culturally tailored introduction
- Behavioral: Threat/Self-efficacy with standard introduction
- Behavioral: Threat/Self-efficacy with culturally tailored introduction
- Behavioral: Social norms message with standard introduction
- Behavioral: Social norms message with culturally tailored introduction
Study Type
Interventional
Enrollment (Actual)
408
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
Rochester, New York, United States, 14642
- University of Rochester Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- self-identify as Hispanic/Latinos
- be 21 years old or older
- have smoking status recorded in the EMR
- patient of URMedicine
Exclusion Criteria:
- Not Hispanic/Latino
- under 21 years of age
- not a smoker
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Reward Message with standard introduction
|
Each text message will be sent 6 times total over two weeks.
Each message type will be combined with a standard introduction.
|
|
Active Comparator: Reward Message with culturally tailored introduction
|
Each text message will be sent 6 times total over two weeks.
Each message type will be combined with an introduction culturally tailored for Hispanic/Latino participants.
|
|
Active Comparator: Threat/Self-efficacy with standard introduction
|
Each text message will be sent 6 times total over two weeks.
Each message type will be combined with a standard introduction.
|
|
Active Comparator: Threat/Self-efficacy with culturally tailored introduction
|
Each text message will be sent 6 times total over two weeks.
Each message type will be combined with an introduction culturally tailored for Hispanic/Latino participants.
|
|
Active Comparator: Social norms message with standard introduction
|
Each text message will be sent 6 times total over two weeks.
Each message type will be combined with a standard introduction.
|
|
Active Comparator: Social norms message with culturally tailored introduction
|
Each text message will be sent 6 times total over two weeks.
Each message type will be combined with an introduction culturally tailored for Hispanic/Latino participants.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Number of participants who enroll in smoking cessation treatment
Time Frame: 2 weeks
|
2 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 9, 2022
Primary Completion (Actual)
May 21, 2022
Study Completion (Actual)
May 21, 2022
Study Registration Dates
First Submitted
March 3, 2022
First Submitted That Met QC Criteria
March 3, 2022
First Posted (Actual)
March 14, 2022
Study Record Updates
Last Update Posted (Actual)
June 10, 2022
Last Update Submitted That Met QC Criteria
June 8, 2022
Last Verified
June 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- STUDY00006544
- R42MD010318 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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