Clinical trial NCT03168451: American Indians STOp Smoking by Mobile Phone
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tobacco Use Cessation
Keywords: text messaging
Lead sponsor: Washington State University
Sponsor class: OTHER
Collaborators: name: Optum, Inc.
First posted: 2017-05-30
Enrollment: 346
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Number of participants who change smoking status as measured by self-report
timeFrame: 6, 12, 18, and 26 weeks after target quit date
Secondary outcomes:
Other outcomes:
Locations:
city: Spokane
country: United States
facility: Washington State University Coordinating Center
state: Washington
Study officials:
affiliation: Washington State University
name: Dedra Buchwald, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Washington State University
name: Sterling McPherson, PhD
role: PRINCIPAL_INVESTIGATOR
References: