American Indians STOp Smoking by Mobile Phone

Tobacco Use Cessation Clinical Trial

— AI STOMP  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03168451
• Other study ID #: P20MD006871
• Status: Completed
• Phase: N/A
• Start date: November 30, 2015
• Est. completion date: September 1, 2018

Study information

• Verified date: September 2018
• Source: Washington State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 346
• Est. completion date: September 1, 2018
• Est. primary completion date: February 28, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Tobacco Use Cessation

Intervention

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.

Locations

Country	Name	City	State
United States	Washington State University Coordinating Center	Spokane	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Washington State University	Optum, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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