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

Smoking Cessation Clinical Trial

— MPACT  

Official title:

Weaving an Islander Network for Cancer Awareness, Research and Training (WINCART): Technology & Smoking Cessation for Late Adolescent/Young Adult Pacific Islanders

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03238456
• Other study ID #: U54CA153458
• Secondary ID: U54CA153458
• Status: Completed
• Phase: N/A
• First received: July 21, 2017
• Last updated: August 2, 2017
• Start date: July 11, 2013
• Est. completion date: May 31, 2015

Study information

• Verified date: August 2017
• Source: Claremont Graduate University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 278
• Est. completion date: May 31, 2015
• Est. primary completion date: December 3, 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Smoking
• Smoking Cessation
• Smoking, Cigarette
• Tobacco Smoking
• Tobacco Use
• Tobacco Use Cessation

Intervention

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.

Locations

Country	Name	City	State
United States	Claremont Graduate University	Claremont	California
United States	California State University Fullerton	Fullerton	California

Sponsors (2)

Lead Sponsor	Collaborator
Claremont Graduate University	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of cigarettes smoked in last 30 days	How many cigarettes has the participant smoked in the last 30 days?	8 months
Primary	Cigarette smoked in past 7 days	Has the participant smoked a cigarette in the past 7 days?	8 months
Primary	Cigarette smoked in past 24 hours	Has the participant smoked a cigarette in the past 24 hours?	8 months
Primary	Expired carbon monoxide (CO)	Biomarker validation (expired CO) of self-reported tobacco use	8 months
Secondary	Number of cigarettes smoked in last 30 days	How many cigarettes has the participant smoked in the last 30 days?	2 months
Secondary	Number of cigarettes smoked in last 30 days	How many cigarettes has the participant smoked in the last 30 days?	5 months
Secondary	Cigarette smoked in past 7 days	Has the participant smoked a cigarette in the past 7 days?	2 months
Secondary	Cigarette smoked in past 7 days	Has the participant smoked a cigarette in the past 7 days?	5 months
Secondary	Cigarette smoked in past 24 hours	Has the participant smoked a cigarette in the past 24 hours?	2 months
Secondary	Cigarette smoked in past 24 hours	Has the participant smoked a cigarette in the past 24 hours?	5 months
Secondary	Expired carbon monoxide (CO)	Biomarker validation (expired CO) of self-reported tobacco use	2 months
Secondary	Expired carbon monoxide (CO)	Biomarker validation (expired CO) of self-reported tobacco use	5 months