NCT03168451

Brief Summary

In an attempt to reduce smoking-related health disparities, investigators will implement a text messaging-based smoking cessation intervention in collaboration with state quit lines. The approach is based on the successful STOMP (STOp smoking by Mobile Phone) program, a text messaging-based smoking cessation intervention among young Maori adults in New Zealand. Investigators will adapt the STOMP intervention, which will result in a new intervention known as AI STOMP (American Indians STOp smoking by Mobile Phone).The primary aim of the study is to determine the effectiveness of the AI-STOMP intervention in smoking cessation among American Indians.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
346

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 30, 2015

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

January 30, 2017

Completed
4 months until next milestone

First Posted

Study publicly available on registry

May 30, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

October 12, 2018

Status Verified

September 1, 2018

Enrollment Period

2.2 years

First QC Date

January 30, 2017

Last Update Submit

October 10, 2018

Conditions

Keywords

text messaging

Outcome Measures

Primary Outcomes (1)

  • Number of participants who change smoking status as measured by self-report

    Number of participants who quit smoking while receiving text messages, as measured by self-report at 4 time points over 6 months.

    6, 12, 18, and 26 weeks after target quit date

Study Arms (2)

Intervention

EXPERIMENTAL

Members of the intervention group will receive culturally tailored text messages encouraging them to quit smoking. They will receive data collection text messages at 6, 12, 18, and 26 weeks post target quit date, assessing their current tobacco smoking behavior.

Behavioral: Culturally Tailored Text Messages

Control

NO INTERVENTION

Members of the control group will receive data collection text messages at 6, 12, 18, and 26 weeks post target quit date, assessing their current tobacco smoking behavior.

Interventions

Members of the intervention group receive culturally tailored messages on the following schedule: 4 messages per day for 1 week prior to target quit date, 4 messages per day for 4 weeks following target quit date, 3 messages per week for 20 weeks following weeks.

Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Identify as American Indian
  • Be age 18 years or older
  • Possess or have access to a mobile phone with text messaging capacity
  • Be a current daily smoker; and
  • Be interested in quitting smoking within the next 30 days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington State University Coordinating Center

Spokane, Washington, 99202, United States

Location

MeSH Terms

Conditions

Tobacco Use Cessation

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Study Officials

  • Dedra Buchwald, MD

    Washington State University

    PRINCIPAL INVESTIGATOR
  • Sterling McPherson, PhD

    Washington State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The intervention group will receive data collection messages and culturally tailored messages encouraging them to quit smoking. The control group will only receive data collection messages.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director and Professor

Study Record Dates

First Submitted

January 30, 2017

First Posted

May 30, 2017

Study Start

November 30, 2015

Primary Completion

February 28, 2018

Study Completion

September 1, 2018

Last Updated

October 12, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share

Locations