Trial Outcomes & Findings for Quit & Fit 2.0: Feasibility and Usability Testing (NCT NCT05878990)

Last Updated: 2024-10-17

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

22 participants

Primary outcome timeframe

Post intervention completion - At 6 weeks

Results posted on

2024-10-17

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	22
Overall Study COMPLETED	14
Overall Study NOT COMPLETED	8

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Overall Study Lost to Follow-up	7
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Quit & Fit 2.0: Feasibility and Usability Testing

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Culturally-tailored Tobacco Treatment Intervention n=22 Participants 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.
Age, Continuous	57 years STANDARD_DEVIATION 9 • n=5 Participants
Sex: Female, Male Female	22 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	22 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	22 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	22 participants n=5 Participants

PRIMARY outcome

Timeframe: Post intervention completion - At 6 weeks

Population: Participants who consented and initiated intervention

Outcome measures

Outcome measures
Measure	Culturally-tailored Tobacco Treatment Intervention n=22 Participants 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 - Post Intervention Post intervention Stage of Change
Feasibility of the 6-week Tobacco Treatment Intervention	14 Participants	—

PRIMARY outcome

Timeframe: Post intervention completion - At 6 weeks

Population: Participants who completed the intervention and the Accessibility and Satisfaction questionnaire.

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.

Outcome measures

Outcome measures
Measure	Culturally-tailored Tobacco Treatment Intervention n=14 Participants 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 - Post Intervention Post intervention Stage of Change
Accessibility and Satisfaction of the 6-week Tobacco Treatment Intervention	56.08 score on a scale Standard Deviation 5.14	—

SECONDARY outcome

Timeframe: Post intervention completion - At 6 weeks

Population: Participants who completed the Fagerström Test for Nicotine Dependence after completing the intervention.

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.

Outcome measures

Outcome measures
Measure	Culturally-tailored Tobacco Treatment Intervention n=14 Participants 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 - Post Intervention Post intervention Stage of Change
Effectiveness of the Intervention (Fagerstrom Test)	2.5 score on a scale Standard Deviation 2.07	—

SECONDARY outcome

Timeframe: 6 weeks post intervention

Population: Participants who completed the air carbon monoxide readings after completing the 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.

Outcome measures

Outcome measures
Measure	Culturally-tailored Tobacco Treatment Intervention n=14 Participants 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 - Post Intervention Post intervention Stage of Change
Effectiveness of the Intervention (Expired Air Carbon Monoxide Readings)	7.125 ppm Standard Deviation 3.72	—

SECONDARY outcome

Timeframe: 6 weeks post intervention

Population: Baseline and post intervention Stage of Change

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.

Outcome measures

Outcome measures
Measure	Culturally-tailored Tobacco Treatment Intervention n=14 Participants 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 - Post Intervention n=14 Participants Post intervention Stage of Change
Effectiveness of Intervention Within the Next 30 Days	9 Participants	6 Participants
Effectiveness of Intervention No Plans to Quit	0 Participants	0 Participants
Effectiveness of Intervention Within the Next 6 Months	5 Participants	5 Participants
Effectiveness of Intervention Quit	0 Participants	3 Participants

Adverse Events

Culturally-tailored Tobacco Treatment Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Lisa Carter-Bawa, PhD, MPH, APRN, ANP-C, FAAN

Hackensack Meridian Health

Phone: 2018803443

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place