Tobacco UseMPACTNCT03238456
Smoking Cessation for Young Adult Pacific Islanders: Motivating Pacifika Against Cigarettes and Tobacco
A study testing Motivating Pacifika Against Cigarettes and Tobacco in people with Tobacco Use and Tobacco Smoking, run by Claremont Graduate University at 2 sites in United States.
Trial summary
The current study aimed to test a culturally tailored program designed to help Pacific Islanders (PIs) between the ages of 18 and 30 quit smoking cigarettes by using a randomized controlled trial design with one intervention group and one control group. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Tobacco Use, Tobacco Smoking, Tobacco Use Cessation
- What is being tested?
- Motivating Pacifika Against Cigarettes and Tobacco
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 278 participants
- Where
- 2 sitesUnited States
- Study dates
- 11 Jul 2013to 31 May 2015
- 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 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Self-identified as Native Hawaiian or Pacific Islander
- Between the ages 18 and 30
- Lived in Southern California
- Would be living in Southern California for the next year
- Owned a cell phone with a text messaging plan
- Had access to a computer with internet for at least 2 hours per week
- Smoked daily or most days of the week (>3 days)
- Smoked at least 100 cigarettes in lifetime
Who cannot join
- Was currently using another smoking cessation method
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Claremont Graduate University
Claremont, California, 91711
California State University Fullerton
Fullerton, California, 92831
About this study
Official title: Weaving an Islander Network for Cancer Awareness, Research and Training (WINCART): Technology & Smoking Cessation for Late Adolescent/Young Adult Pacific Islanders
The current study aimed to test a culturally tailored program designed to help Pacific Islanders (PIs) between the ages of 18 and 30 quit smoking cigarettes by using a randomized controlled trial design with one intervention group and one control group.
Read the detailed description
This randomized control trial (RCT) consisted of a baseline assessment (Wave 0) and three follow-up assessments (Waves 1-3). Follow-up assessments were conducted at 2 months, 5 months, and 8 months after the baseline assessment. The objective of the study was to test a culturally-tailored online program designed to help PI young adults quit smoking cigarettes. The online program contained (1) personalized, automated text messages, (2) interactive, online educational modules, and (3) an online forum.
Hypotheses for this study include:
- Participants in the intervention program tailored to PIs would have significantly higher rates of abstinence, lower rates of relapse, and lower smoking frequency and intensity at each follow-up time point than those in the standard intervention program.
- Participants with impaired affective decision capacity (low scores on Iowa Gambling Task (IGT)) would benefit more from the tailored intervention program than participants with normal affective decision capacity (high IGT scores).
- Effects from the tailored intervention program would be more pronounced among participants with particular dispositional phenotypes (depression, hostility, impulsivity) and baseline severity of tobacco addiction (nicotine dependence).
- High-intensity users of the tailored intervention program would be more successful than low intensity users in reducing the frequency and intensity of cigarettes smoked.
- The tailored intervention program would have greater success at engaging and retaining participants than the standard intervention program.
- Conditions
- Tobacco Use, Tobacco Smoking, Tobacco Use Cessation, Smoking, Smoking Cessation, Smoking, Cigarette
- Being tested
- Motivating Pacifika Against Cigarettes and Tobacco
- Keywords
- Pacific Islander, Native Hawaiian, NHPI, Tobacco Health, Tobacco Use, Tobacco Smoking, Tobacco Use Cessation, Smoking Cessation, Smoking, Cigarette Use, Young Adult
- Medical subject headings
- Tobacco Use, Tobacco Smoking, Tobacco Use Cessation, Smoking, Smoking Cessation, Cigarette Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivating Pacifika Against Cigarettes and TobaccoBehavioural
Also called MPACT
Participants received one encouraging text message per day prior to their quit date. During the intervention, they received daily text messages with decreasing frequency per week. Participants were also able to craft personal text messages. On-demand text messages were optional and could be requested by texting key words to the program hotline.
The online MPACT program allowed participants to access eight educational modules and a forum where they could communicate with other participants. The modules focused on different aspects of quitting smoking, such as how to deal with withdrawal symptoms, triggers of tobacco use, and stress. Participants were limited to one module per day in order to increase the duration of exposure to the program. Upon completion, participants no longer received text messages but they were still able to access the educational modules, forum, and on-demand text messages.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The intervention entitled Motivating Pacifika Against Cigarettes and Tobacco (MPACT) was implemented for eight weeks starting on the quit date that the participant chose with their assigned coach during the baseline assessment. At the baseline assessment, each participant watched an introductory video that described the online smoking cessation program. The online program was accessed through the participant's Facebook account. The program included eight education modules and a forum. Participants also received automated daily text messages to provide support and encouragement during the quitting process. Receives: Behavioral: Motivating Pacifika Against Cigarettes and Tobacco |
| Control | No intervention | Participants in the control group set a quit date within two weeks of their baseline assessment and watched an introductory video that described the smoking cessation program. They received one text message every other week over a period of eight weeks following the quit date. The messages were delivered by a web-based system not connected to the online intervention program. Participants were also given a handout listing local tobacco cessation and education resources, a link to a generic online smoking cessation program, a fact sheet on smoking and tobacco use among PI young adults, and a quit kit containing chewing gum and a stress ball. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of cigarettes smoked in last 30 days
How many cigarettes has the participant smoked in the last 30 days?
Measured: 8 months
Cigarette smoked in past 7 days
Has the participant smoked a cigarette in the past 7 days?
Measured: 8 months
Cigarette smoked in past 24 hours
Has the participant smoked a cigarette in the past 24 hours?
Measured: 8 months
Expired carbon monoxide (CO)
Biomarker validation (expired CO) of self-reported tobacco use
Measured: 8 months
Secondary outcomes (8)
Number of cigarettes smoked in last 30 days
How many cigarettes has the participant smoked in the last 30 days?
Measured: 2 months
Number of cigarettes smoked in last 30 days
How many cigarettes has the participant smoked in the last 30 days?
Measured: 5 months
Cigarette smoked in past 7 days
Has the participant smoked a cigarette in the past 7 days?
Measured: 2 months
Cigarette smoked in past 7 days
Has the participant smoked a cigarette in the past 7 days?
Measured: 5 months
Cigarette smoked in past 24 hours
Has the participant smoked a cigarette in the past 24 hours?
Measured: 2 months
Cigarette smoked in past 24 hours
Has the participant smoked a cigarette in the past 24 hours?
Measured: 5 months
Expired carbon monoxide (CO)
Biomarker validation (expired CO) of self-reported tobacco use
Measured: 2 months
Expired carbon monoxide (CO)
Biomarker validation (expired CO) of self-reported tobacco use
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2017
- Study start11 Jul 2013
- Primary completion3 Dec 2014
- Study completion31 May 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco UseStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 278 participants (actual)
Sponsor and investigators
- Lead sponsor
- Claremont Graduate University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03238456
- Sponsor's protocol ID
- U54CA153458
- Other IDs
- U54CA153458
- Acronym
- MPACT
- Status last verified
- Aug 2017
- First submitted
- 21 Jul 2017
- Last updated
- 4 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified datasets with individual participant data will be provided by the Principal Investigator upon request. All data sharing requests will be reviewed and approved by the Office of Research and Sponsored Programs at Claremont Graduate University and the WINCART2 Center Steering Committee.
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Weaving an Islander Network for Cancer Awareness, Research and Training (WINCART): Technology & Smoking Cessation for Late Adolescent/Young Adult Pacific Islanders
- ClinicalTrials.gov ID
- NCT03238456
- Acronym / sponsor ID
- MPACT / U54CA153458
- Conditions
- Tobacco Use, Tobacco Smoking, Tobacco Use Cessation, Smoking, Smoking Cessation, Smoking, Cigarette
- Keywords
- Pacific Islander, Native Hawaiian, NHPI, Tobacco Health, Tobacco Use, Tobacco Smoking, Tobacco Use Cessation, Smoking Cessation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 278 participants (actual)
- Lead sponsor
- Claremont Graduate UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 11 Jul 2013 (actual)
- Primary completion
- 3 Dec 2014 (actual)
- Study completion
- 31 May 2015 (actual)
- First posted
- 3 Aug 2017 (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.
The current study aimed to test a culturally tailored program designed to help Pacific Islanders (PIs) between the ages of 18 and 30 quit smoking cigarettes by using a randomized controlled trial design with one intervention group and one control group.
Detailed description
This randomized control trial (RCT) consisted of a baseline assessment (Wave 0) and three follow-up assessments (Waves 1-3). Follow-up assessments were conducted at 2 months, 5 months, and 8 months after the baseline assessment. The objective of the study was to test a culturally-tailored online program designed to help PI young adults quit smoking cigarettes. The online program contained (1) personalized, automated text messages, (2) interactive, online educational modules, and (3) an online forum.
Hypotheses for this study include:
- Participants in the intervention program tailored to PIs would have significantly higher rates of abstinence, lower rates of relapse, and lower smoking frequency and intensity at each follow-up time point than those in the standard intervention program.
- Participants with impaired affective decision capacity (low scores on Iowa Gambling Task (IGT)) would benefit more from the tailored intervention program than participants with normal affective decision capacity (high IGT scores).
- Effects from the tailored intervention program would be more pronounced among participants with particular dispositional phenotypes (depression, hostility, impulsivity) and baseline severity of tobacco addiction (nicotine dependence).
- High-intensity users of the tailored intervention program would be more successful than low intensity users in reducing the frequency and intensity of cigarettes smoked.
- The tailored intervention program would have greater success at engaging and retaining participants than the standard intervention program.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Motivating Pacifika Against Cigarettes and TobaccoThe intervention entitled Motivating Pacifika Against Cigarettes and Tobacco (MPACT) was implemented for eight weeks starting on the quit date that the participant chose with their assigned coach during the baseline assessment. At the baseline assessment, each participant watched an introductory video that described the online smoking cessation program. The online program was accessed through the participant's Facebook account. The program included eight education modules and a forum. Participants also received automated daily text messages to provide support and encouragement during the quitting process. |
| Control | No intervention | –Participants in the control group set a quit date within two weeks of their baseline assessment and watched an introductory video that described the smoking cessation program. They received one text message every other week over a period of eight weeks following the quit date. The messages were delivered by a web-based system not connected to the online intervention program. Participants were also given a handout listing local tobacco cessation and education resources, a link to a generic online smoking cessation program, a fact sheet on smoking and tobacco use among PI young adults, and a quit kit containing chewing gum and a stress ball. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Self-identified as Native Hawaiian or Pacific Islander
- Between the ages 18 and 30
- Lived in Southern California
- Would be living in Southern California for the next year
- Owned a cell phone with a text messaging plan
Key exclusion criteria (1 listed)
- Was currently using another smoking cessation method
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 |
|---|---|---|
| Motivating Pacifika Against Cigarettes and TobaccoAlso: MPACTParticipants received one encouraging text message per day prior to their quit date. During the intervention, they received daily text messages with decreasing frequency per week. Participants were also able to craft personal text messages. On-demand text messages were optional and could be requested by texting key words to the program hotline. The online MPACT program allowed participants to access eight educational modules and a forum where they could communicate with other participants. The modules focused on different aspects of quitting smoking, such as how to deal with withdrawal symptoms, triggers of tobacco use, and stress. Participants were limited to one module per day in order to increase the duration of exposure to the program. Upon completion, participants no longer received text messages but they were still able to access the educational modules, forum, and on-demand text messages. | Behavioural | Intervention |
Primary outcome
Number of cigarettes smoked in last 30 days
Time frame: 8 months
How many cigarettes has the participant smoked in the last 30 days?
Cigarette smoked in past 7 days
Time frame: 8 months
Has the participant smoked a cigarette in the past 7 days?
Cigarette smoked in past 24 hours
Time frame: 8 months
Has the participant smoked a cigarette in the past 24 hours?
Expired carbon monoxide (CO)
Time frame: 8 months
Biomarker validation (expired CO) of self-reported tobacco use
8 secondary outcomes
Number of cigarettes smoked in last 30 days
Time frame: 2 months
Number of cigarettes smoked in last 30 days
Time frame: 5 months
Cigarette smoked in past 7 days
Time frame: 2 months
Cigarette smoked in past 7 days
Time frame: 5 months
Cigarette smoked in past 24 hours
Time frame: 2 months
Cigarette smoked in past 24 hours
Time frame: 5 months
Expired carbon monoxide (CO)
Time frame: 2 months
Expired carbon monoxide (CO)
Time frame: 5 months
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 4 Aug 2017.
- Individual participant dataSharing planned: Yes. De-identified datasets with individual participant data will be provided by the Principal Investigator upon request. All data sharing requests will be reviewed and approved by the Office of Research and Sponsored Programs at Claremont Graduate University and the WINCART2 Center Steering Committee.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivating Pacifika Against Cigarettes and Tobacco in people with Tobacco Use and Tobacco Smoking, run by Claremont Graduate University at 2 sites in United States.
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 8 inclusion and 1 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 4 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 cigarettes smoked in last 30 days (time frame: 8 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Aug 2017.