Smoking CessationNCT05278481

Latinos Kick Buts: Mobile Engagement and Cessation Support for Latino Smokers

A study testing Reward Message with standard introduction, Reward Message with culturally tailored introduction and Threat/Self-efficacy with standard introduction in people with Smoking Cessation, run by University of Rochester at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 21 years and olderHealthy volunteers can take part
Conditions the study is for: Smoking Cessation
What is being tested?: Reward Message with standard introduction, Reward Message with culturally tailored introduction and Threat/Self-efficacy with standard introduction
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 408 participants
Where: 1 siteUnited States
Study dates: 9 May 2022to 21 May 2022
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

self-identify as Hispanic/Latinos
be 21 years old or older
have smoking status recorded in the EMR
patient of URMedicine

Who cannot join

Not Hispanic/Latino
under 21 years of age
not a smoker

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Rochester Medical Center
Rochester, New York, 14642

Other trials in United States

About this study

Official title: 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.

Conditions: Smoking Cessation
Being tested: Reward Message with standard introduction, Reward Message with culturally tailored introduction, Threat/Self-efficacy with standard introduction, Threat/Self-efficacy with culturally tailored introduction, Social norms message with standard introduction
Medical subject headings: Smoking Cessation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Reward Message with standard introductionBehavioural
Each text message will be sent 6 times total over two weeks. Each message type will be combined with a standard introduction.
Reward Message with culturally tailored introductionBehavioural
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.
Threat/Self-efficacy with standard introductionBehavioural
Each text message will be sent 6 times total over two weeks. Each message type will be combined with a standard introduction.
Threat/Self-efficacy with culturally tailored introductionBehavioural
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.
Social norms message with standard introductionBehavioural
Each text message will be sent 6 times total over two weeks. Each message type will be combined with a standard introduction.
Social norms message with culturally tailored introductionBehavioural
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.

Study groups in NCT05278481
Study group	Role	What they receive
Reward Message with standard introduction	Active comparator	Not described Receives: Behavioral: Reward Message with standard introduction
Reward Message with culturally tailored introduction	Active comparator	Not described Receives: Behavioral: Reward Message with culturally tailored introduction
Threat/Self-efficacy with standard introduction	Active comparator	Not described Receives: Behavioral: Threat/Self-efficacy with standard introduction
Threat/Self-efficacy with culturally tailored introduction	Active comparator	Not described Receives: Behavioral: Threat/Self-efficacy with culturally tailored introduction
Social norms message with standard introduction	Active comparator	Not described Receives: Behavioral: Social norms message with standard introduction
Social norms message with culturally tailored introduction	Active comparator	Not described Receives: Behavioral: Social norms message with culturally tailored introduction

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of participants who enroll in smoking cessation treatment
Measured: 2 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

9 May 202221 May 2022

First posted14 Mar 2022
Study start9 May 2022
Primary completion21 May 2022
Study completion21 May 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Smoking CessationStudies of the same condition, open and under way.
More trials run by University of RochesterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Factorial
Model description: 3 x 2 factorial design
Masking: None (open label)
Enrolment: 408 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05278481
Sponsor's protocol ID: STUDY00006544
Other IDs: R42MD010318
Status last verified: Jun 2022
First submitted: 3 Mar 2022
Last updated: 10 Jun 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Enrolling by invitationObservational study
Using Smartwatches to Monitor Smoking in Real-life Situations
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PROMETHEE: A Shared Interregional Tele-Tobacco Cessation Platform Embedded Within the IMPULSION Lung Cancer Screening Program
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Impacto 2.0: Mobile Smoking Cessation Across Texas
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Smoking Cessation Program for Lao People With HIV
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Studying NMDA and Sigma-1 in Smoking Cessation Treatment (SUMMIT)
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All Smoking Cessation trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Latinos Kick Buts: Mobile Engagement and Cessation Support for Latino Smokers Pilot Study
ClinicalTrials.gov ID: NCT05278481
Acronym / sponsor ID: STUDY00006544
Conditions: Smoking Cessation
Study type: Interventional
Recruitment status: Completed
Enrolment: 408 participants (actual)
Lead sponsor: University of RochesterUniversity, hospital or other
Collaborators: National Institute on Minority Health and Health Disparities (NIMHD)
Study start: 9 May 2022 (actual)
Primary completion: 21 May 2022 (actual)
Study completion: 21 May 2022 (actual)
First posted: 14 Mar 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Factorial
Masking: None (open label)
Number of arms: 6
Model description: 3 x 2 factorial design

Arm	Type	Receives
Reward Message with standard introduction	Active comparator	Behavioral: Reward Message with standard introduction
Reward Message with culturally tailored introduction	Active comparator	Behavioral: Reward Message with culturally tailored introduction
Threat/Self-efficacy with standard introduction	Active comparator	Behavioral: Threat/Self-efficacy with standard introduction
Threat/Self-efficacy with culturally tailored introduction	Active comparator	Behavioral: Threat/Self-efficacy with culturally tailored introduction
Social norms message with standard introduction	Active comparator	Behavioral: Social norms message with standard introduction
Social norms message with culturally tailored introduction	Active comparator	Behavioral: Social norms message with culturally tailored introduction

Who may qualify

Ages: 21 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

self-identify as Hispanic/Latinos
be 21 years old or older
have smoking status recorded in the EMR
patient of URMedicine

Key exclusion criteria (3 listed)

Not Hispanic/Latino
under 21 years of age
not a smoker

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Reward Message with standard introductionEach text message will be sent 6 times total over two weeks. Each message type will be combined with a standard introduction.	Behavioural	Reward Message with standard introduction
Reward Message with culturally tailored introductionEach 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.	Behavioural	Reward Message with culturally tailored introduction
Threat/Self-efficacy with standard introductionEach text message will be sent 6 times total over two weeks. Each message type will be combined with a standard introduction.	Behavioural	Threat/Self-efficacy with standard introduction
Threat/Self-efficacy with culturally tailored introductionEach 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.	Behavioural	Threat/Self-efficacy with culturally tailored introduction
Social norms message with standard introductionEach text message will be sent 6 times total over two weeks. Each message type will be combined with a standard introduction.	Behavioural	Social norms message with standard introduction
Social norms message with culturally tailored introductionEach 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.	Behavioural	Social norms message with culturally tailored introduction

Primary outcome

Number of participants who enroll in smoking cessation treatment
Time frame: 2 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2022.
Individual participant dataSharing planned: No

Related trials for Smoking Cessation

Enrolling by invitationObservational study
Using Smartwatches to Monitor Smoking in Real-life Situations
Smoking
Not yet recruitingObservational study
PROMETHEE: A Shared Interregional Tele-Tobacco Cessation Platform Embedded Within the IMPULSION Lung Cancer Screening Program
Smoking Cessation, Lung Cancer Screening
Not yet recruiting
Impacto 2.0: Mobile Smoking Cessation Across Texas
Cigarette Smoking, Smoking Cessation
Not yet recruiting
Smoking Cessation Program for Lao People With HIV
Smoking Cessation, HIV
RecruitingPhase 3
Studying NMDA and Sigma-1 in Smoking Cessation Treatment (SUMMIT)
Smoking Cessation

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants who enroll in smoking cessation treatment (time frame: 2 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05278481.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2022.