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American Indians STOp Smoking by Mobile Phone (AI STOMP)

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ClinicalTrials.gov Identifier: NCT03168451
Recruitment Status : Completed
First Posted : May 30, 2017
Last Update Posted : October 12, 2018
Sponsor:
Collaborator:
Optum, Inc.
Information provided by (Responsible Party):
Dedra Buchwald, Washington State University

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.

Condition or disease Intervention/treatment Phase
Tobacco Use Cessation Behavioral: Culturally Tailored Text Messages Not Applicable

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  (Clinical Trial)
Actual Enrollment : 346 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: Single (Participant)
Primary Purpose: Treatment
Actual Study Start Date : November 30, 2015
Actual Primary Completion Date : February 28, 2018
Actual Study Completion Date : September 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Smoking

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.



Primary Outcome Measures :
  1. Number of participants who change smoking status as measured by self-report [ Time Frame: 6, 12, 18, and 26 weeks after target quit date ]
    Number of participants who quit smoking while receiving text messages, as measured by self-report at 4 time points over 6 months.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

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): NCT03168451


Locations
United States, Washington
Washington State University Coordinating Center
Spokane, Washington, United States, 99202
Sponsors and Collaborators
Washington State University
Optum, Inc.
Investigators
Principal Investigator: Dedra Buchwald, MD Washington State University
Principal Investigator: Sterling McPherson, PhD Washington State University

Responsible Party: Dedra Buchwald, Director and Professor, Washington State University
ClinicalTrials.gov Identifier: NCT03168451     History of Changes
Other Study ID Numbers: P20MD006871 ( U.S. NIH Grant/Contract )
First Posted: May 30, 2017    Key Record Dates
Last Update Posted: October 12, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Keywords provided by Dedra Buchwald, Washington State University:
text messaging