American Indians STOp Smoking by Mobile Phone (AI STOMP)

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.

Study Overview

• Status: Completed
• Conditions: Tobacco Use Cessation
• Intervention / Treatment: Behavioral: Culturally Tailored Text Messages

Detailed Description

This is a randomized, single-blinded, controlled trial examining the effectiveness of a text messaging-based smoking cessation program among American Indian (AI) smokers who call state quit lines, in states with high AI populations. Participants will be randomized to either receive culturally-tailored text-messages to support smoking cessation or quit line's treatment as usual.

Participants will be recruited by Optum, the company who runs many state quit lines in the US. If - after answering some demographic questions for Optum from the following states: Alaska, Oklahoma, Wisconsin, Minnesota, and New Mexico - a person is found to be a AI/AN and 18+ years old, that person will be asked if they would like to receive information about the study. If they answer yes the WSU research team will receive their contact information from Optum via a secure email, and WSU researchers will send a text explaining the study in more detail and a link to the e-consent form.

Participants will also fill out 4 baseline questionnaires. After filling out baseline questionnaires, participants will be randomized to either the intervention group or the control group. Participants will be stratified into the intervention and control groups based on their age, gender, and Fagerstrom nicotine dependence score. Random permuted blocks will be used by on-campus research staff to manually assign participants to the two research groups.

All participants will begin receiving text messages one week before their chosen quit date.

• Study Type: Interventional
• Enrollment (Actual): 346
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Spokane, Washington, United States, 99202
      • Washington State University Coordinating Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• Not meeting inclusion criteria

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; 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; 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.
No Intervention: Control; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Washington State University
• Collaborators: Optum, Inc.
• Investigators: Principal Investigator: Sterling McPherson, PhD, Washington State University; Principal Investigator: Dedra Buchwald, MD, Washington State University

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2015
• Primary Completion (Actual): February 28, 2018
• Study Completion (Actual): September 1, 2018

Study Registration Dates

• First Submitted: January 30, 2017
• First Submitted That Met QC Criteria: May 24, 2017
• First Posted (Actual): May 30, 2017

Study Record Updates

• Last Update Posted (Actual): October 12, 2018
• Last Update Submitted That Met QC Criteria: October 10, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: text messaging
• Other Study ID Numbers: P20MD006871 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No