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Trial record 2 of 11 for:    MPACT

Smoking Cessation for Young Adult Pacific Islanders: Motivating Pacifika Against Cigarettes and Tobacco (MPACT)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT03238456
First Posted: August 3, 2017
Last Update Posted: August 4, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Claremont Graduate University
  Purpose
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.

Condition Intervention
Tobacco Use Tobacco Smoking Tobacco Use Cessation Smoking Smoking Cessation Smoking, Cigarette Behavioral: Motivating Pacifika Against Cigarettes and Tobacco

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Weaving an Islander Network for Cancer Awareness, Research and Training (WINCART): Technology & Smoking Cessation for Late Adolescent/Young Adult Pacific Islanders

Resource links provided by NLM:


Further study details as provided by Claremont Graduate University:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • Number of cigarettes smoked in last 30 days [ Time Frame: 2 months ]
    How many cigarettes has the participant smoked in the last 30 days?

  • Number of cigarettes smoked in last 30 days [ Time Frame: 5 months ]
    How many cigarettes has the participant smoked in the last 30 days?

  • Cigarette smoked in past 7 days [ Time Frame: 2 months ]
    Has the participant smoked a cigarette in the past 7 days?

  • Cigarette smoked in past 7 days [ Time Frame: 5 months ]
    Has the participant smoked a cigarette in the past 7 days?

  • Cigarette smoked in past 24 hours [ Time Frame: 2 months ]
    Has the participant smoked a cigarette in the past 24 hours?

  • Cigarette smoked in past 24 hours [ Time Frame: 5 months ]
    Has the participant smoked a cigarette in the past 24 hours?

  • Expired carbon monoxide (CO) [ Time Frame: 2 months ]
    Biomarker validation (expired CO) of self-reported tobacco use

  • Expired carbon monoxide (CO) [ Time Frame: 5 months ]
    Biomarker validation (expired CO) of self-reported tobacco use


Enrollment: 278
Actual Study Start Date: July 11, 2013
Study Completion Date: May 31, 2015
Primary Completion Date: December 3, 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention
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.
Behavioral: Motivating Pacifika Against Cigarettes and Tobacco

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.

Other Name: MPACT
No Intervention: Control
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.

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:

  1. 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.
  2. 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).
  3. 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).
  4. 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.
  5. The tailored intervention program would have greater success at engaging and retaining participants than the standard intervention program.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

• Was currently using another smoking cessation method

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03238456


Locations
United States, California
Claremont Graduate University
Claremont, California, United States, 91711
California State University Fullerton
Fullerton, California, United States, 92831
Sponsors and Collaborators
Claremont Graduate University
National Cancer Institute (NCI)
  More Information

Responsible Party: Claremont Graduate University
ClinicalTrials.gov Identifier: NCT03238456     History of Changes
Other Study ID Numbers: U54CA153458 ( U.S. NIH Grant/Contract )
First Submitted: July 21, 2017
First Posted: August 3, 2017
Last Update Posted: August 4, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Claremont Graduate University:
Pacific Islander
Native Hawaiian
NHPI
Tobacco Health
Tobacco Use
Tobacco Smoking
Tobacco Use Cessation
Smoking Cessation
Smoking
Cigarette Use
Young Adult