Quit & Fit 2.0: Feasibility and Usability Testing
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Hackensack Meridian Health
- Enrollment
- 22
- Locations
- 1
- Primary Endpoint
- Feasibility of the 6-week Tobacco Treatment Intervention
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 69 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Culturally-tailored Tobacco Treatment Intervention
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.
Intervention: Culturally-tailored Tobacco Treatment (Behavioral)
Culturally-tailored Tobacco Treatment Intervention
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.
Intervention: Culturally-tailored Content Newsletters (Behavioral)
Preference-Driven Culturally-tailored Tobacco Treatment Intervention
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.
Intervention: Culturally-tailored Tobacco Treatment (Behavioral)
Preference-Driven Culturally-tailored Tobacco Treatment Intervention
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.
Intervention: Control Preference Scale (Behavioral)
Preference-Driven Culturally-tailored Tobacco Treatment Intervention
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.
Intervention: Active Content Newsletter or Passive Content Newsletter (Behavioral)
Outcomes
Primary Outcomes
Feasibility of the 6-week Tobacco Treatment Intervention
Time Frame: 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
Time Frame: 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 Outcomes
- Effectiveness of the Intervention (Fagerstrom Test)(Post intervention completion - At 6 weeks)
- Effectiveness of the Intervention (Expired Air Carbon Monoxide Readings)(6 weeks post intervention)
- Effectiveness of Intervention(6 weeks post intervention)