American Indians STOp Smoking by Mobile Phone (AI STOMP)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03168451|
Recruitment Status : Recruiting
First Posted : May 30, 2017
Last Update Posted : May 30, 2017
|Condition or disease||Intervention/treatment||Phase|
|Tobacco Use Cessation||Behavioral: Culturally Tailored Text Messages||Not Applicable|
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)|
|Estimated Enrollment :||500 participants|
|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.|
|Actual Study Start Date :||November 2015|
|Estimated Primary Completion Date :||March 31, 2018|
|Estimated Study Completion Date :||March 31, 2018|
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.
- 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.
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
|Contact: Jo Ann Dotson, PhD, RNfirstname.lastname@example.org|
|Contact: Lonnie Nelson, PhDemail@example.com|
|United States, Washington|
|Washington State University Coordinating Center||Recruiting|
|Spokane, Washington, United States, 99202|
|Contact: Jo Ann Dotson, PhD RN firstname.lastname@example.org|
|Principal Investigator:||Dedra Buchwald, MD||Washington State University|
|Principal Investigator:||Sterling McPherson, PhD||Washington State University|