NCT03238456

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
278

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2013

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 11, 2013

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 3, 2014

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2015

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

July 21, 2017

Completed
13 days until next milestone

First Posted

Study publicly available on registry

August 3, 2017

Completed
Last Updated

August 4, 2017

Status Verified

August 1, 2017

Enrollment Period

1.4 years

First QC Date

July 21, 2017

Last Update Submit

August 2, 2017

Conditions

Keywords

Pacific IslanderNative HawaiianNHPITobacco HealthTobacco UseTobacco SmokingTobacco Use CessationSmoking CessationSmokingCigarette UseYoung Adult

Outcome Measures

Primary Outcomes (4)

  • Number of cigarettes smoked in last 30 days

    How many cigarettes has the participant smoked in the last 30 days?

    8 months

  • Cigarette smoked in past 7 days

    Has the participant smoked a cigarette in the past 7 days?

    8 months

  • Cigarette smoked in past 24 hours

    Has the participant smoked a cigarette in the past 24 hours?

    8 months

  • Expired carbon monoxide (CO)

    Biomarker validation (expired CO) of self-reported tobacco use

    8 months

Secondary Outcomes (8)

  • Number of cigarettes smoked in last 30 days

    2 months

  • Number of cigarettes smoked in last 30 days

    5 months

  • Cigarette smoked in past 7 days

    2 months

  • Cigarette smoked in past 7 days

    5 months

  • Cigarette smoked in past 24 hours

    2 months

  • +3 more secondary outcomes

Study Arms (2)

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.

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.

Interventions

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.

Also known as: MPACT
Intervention

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Was currently using another smoking cessation method

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Claremont Graduate University

Claremont, California, 91711, United States

Location

California State University Fullerton

Fullerton, California, 92831, United States

Location

MeSH Terms

Conditions

Tobacco UseTobacco SmokingTobacco Use CessationSmokingSmoking CessationCigarette Smoking

Interventions

Tobacco Products

Condition Hierarchy (Ancestors)

BehaviorHealth Behavior

Intervention Hierarchy (Ancestors)

Smoking DevicesManufactured MaterialsTechnology, Industry, and Agriculture

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 21, 2017

First Posted

August 3, 2017

Study Start

July 11, 2013

Primary Completion

December 3, 2014

Study Completion

May 31, 2015

Last Updated

August 4, 2017

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will share

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.

Locations