Quit & Fit 2.0: Feasibility and Usability Testing

Not Applicable

Completed

• Conditions: Smoking Cessation
• Interventions: Behavioral: Culturally-tailored Tobacco Treatment; Behavioral: Culturally-tailored Content Newsletters; Behavioral: Control Preference Scale; Behavioral: Active Content Newsletter or Passive Content Newsletter

• Registration Number: NCT05878990
• Lead Sponsor: Hackensack Meridian Health

Brief Summary

Pilot randomized controlled trial to compare tobacco cessation rates of two arms: a 6-week culturally tailored tobacco cessation intervention versus a 6-week personalized culturally-tailored tobacco cessation intervention among African American women.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-04-05
• Study First Submitted: 2023-05-18
• Study First Submitted QC: 2023-05-18
• Study First Posted: 2023-05-30
• Primary Completion: 2024-04-30
• Study Completion: 2024-04-30
• Results First Submitted: 2024-07-08
• Status Verified: 2024-10
• Results First Submitted QC: 2024-10-16
• Last Update Submitted: 2024-10-16
• Results First Posted: 2024-10-17
• Last Update Posted: 2024-10-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 22

Inclusion Criteria

• Self-identify as an African American woman
• Currently smoke 5 cigarettes per day or more
• Has smoked daily for the past one year
• Able to provide informed consent
• Generally good health as determined by medical history

Exclusion Criteria

• Currently pregnant
• Diagnosis of cardiovascular disease
• Diagnosis of lung disease
• Diagnosis of mental illness
• Adults unable to consent
• Individuals who are not yet adults (infants, children, teenagers)
• Prisoners

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Culturally-tailored Tobacco Treatment Intervention	Culturally-tailored Tobacco Treatment	Upon consent, participants will complete a baseline survey, receive the home Carbon monoxide monitor and instructions on how to use, and be scheduled for weekly telephone calls with a certified tobacco treatment specialist (CTTS) for 6 weeks. The culturally-tailored tobacco intervention content by week via telephone call with the CTTS includes among others: Reasons and Motivations for Quitting, Benefits of Quitting, Stress Management and Discussion about Environmental Influences. Participants will also receive weekly Culturally-tailored Content Newsletters emailed after their weekly cessation counseling session.
Culturally-tailored Tobacco Treatment Intervention	Culturally-tailored Content Newsletters	Upon consent, participants will complete a baseline survey, receive the home Carbon monoxide monitor and instructions on how to use, and be scheduled for weekly telephone calls with a certified tobacco treatment specialist (CTTS) for 6 weeks. The culturally-tailored tobacco intervention content by week via telephone call with the CTTS includes among others: Reasons and Motivations for Quitting, Benefits of Quitting, Stress Management and Discussion about Environmental Influences. Participants will also receive weekly Culturally-tailored Content Newsletters emailed after their weekly cessation counseling session.
Preference-Driven Culturally-tailored Tobacco Treatment Intervention	Culturally-tailored Tobacco Treatment	Upon consent, participants will complete a baseline survey, receive the home Carbon monoxide monitor and instructions on how to use, and be scheduled for weekly telephone calls with a certified tobacco treatment specialist (CTTS) for 6 weeks. The culturally-tailored tobacco intervention content by week via telephone call with the CTTS includes among others: Reasons and Motivations for Quitting, Benefits of Quitting, Stress Management and Discussion about Environmental Influences. Participants will complete the one-item Control Preference Scale and receive either an Active Content Newsletter or Passive Content Newsletter emailed after their weekly cessation counseling session.
Preference-Driven Culturally-tailored Tobacco Treatment Intervention	Control Preference Scale	Upon consent, participants will complete a baseline survey, receive the home Carbon monoxide monitor and instructions on how to use, and be scheduled for weekly telephone calls with a certified tobacco treatment specialist (CTTS) for 6 weeks. The culturally-tailored tobacco intervention content by week via telephone call with the CTTS includes among others: Reasons and Motivations for Quitting, Benefits of Quitting, Stress Management and Discussion about Environmental Influences. Participants will complete the one-item Control Preference Scale and receive either an Active Content Newsletter or Passive Content Newsletter emailed after their weekly cessation counseling session.
Preference-Driven Culturally-tailored Tobacco Treatment Intervention	Active Content Newsletter or Passive Content Newsletter	Upon consent, participants will complete a baseline survey, receive the home Carbon monoxide monitor and instructions on how to use, and be scheduled for weekly telephone calls with a certified tobacco treatment specialist (CTTS) for 6 weeks. The culturally-tailored tobacco intervention content by week via telephone call with the CTTS includes among others: Reasons and Motivations for Quitting, Benefits of Quitting, Stress Management and Discussion about Environmental Influences. Participants will complete the one-item Control Preference Scale and receive either an Active Content Newsletter or Passive Content Newsletter emailed after their weekly cessation counseling session.

Primary Outcome Measures

Name	Time	Method
Feasibility of the 6-week Tobacco Treatment Intervention	Post intervention completion - At 6 weeks	Examine the feasibility of a 6-week community-based culturally tailored tobacco treatment intervention to a preference driven culturally-tailored tobacco treatment intervention targeted to African American women by assessing the number of participants that complete all 6-week tobacco treatment calls.
Accessibility and Satisfaction of the 6-week Tobacco Treatment Intervention	Post intervention completion - At 6 weeks	Examine the acceptability and satisfaction of a 6-week community-based culturally-tailored tobacco treatment intervention to a preference driven culturally-tailored tobacco treatment intervention targeted to African American women using the 17-item Acceptability \& Satisfaction Questionnaire. Accessibility and Satisfaction and measured using a score that ranges from 17 to 68 with higher scores representing higher Accessibility and Satisfaction.

Secondary Outcome Measures

Name	Time	Method
Effectiveness of the Intervention (Fagerstrom Test)	Post intervention completion - At 6 weeks	Evaluate the effectiveness of a 6-week community-based culturally-tailored tobacco treatment intervention using the Fagerstrom Test for Nicotine Dependence. The Fagerström Test for Nicotine Dependence is a psychometrically-validated self-report 6-item tool to measure an individuals' level of nicotine dependence with a total scale score ranging from 0-10 with higher scores indicative of higher levels of nicotine dependence.
Effectiveness of the Intervention (Expired Air Carbon Monoxide Readings)	6 weeks post intervention	Evaluate the effectiveness of a 6-week community-based culturally-tailored tobacco treatment intervention using expired air carbon monoxide readings. Higher carbon monoxide readings are associated with worse outcomes.
Effectiveness of Intervention	6 weeks post intervention	Evaluate the effectiveness of a 6-week community-based culturally-tailored tobacco treatment intervention using Stage of Change for Tobacco Cessation. The "Stage of Change for Tobacco Cessation" measures participants intention to quit smoking and has 4 categories: No Plans to Quit / Within the Next 6 Months/ Within the Next 30 Days / Quit. Results were compared to baseline Stage of Change.

Trial Locations

Locations (1)

Hackensack Meridian Health - Center for Discovery and Innovation; 🇺🇸 Nutley, New Jersey, United States