Quit & Fit 2.0: Feasibility and Usability Testing

Sponsor
Hackensack Meridian Health (Other)
Overall Status
Recruiting
CT.gov ID
NCT05878990
Collaborator
(none)
20
1
2
13
1.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Culturally-tailored Tobacco Treatment
  • Behavioral: Culturally-tailored Content Newsletters
  • Behavioral: Control Preference Scale
  • Behavioral: Active Content Newsletter or Passive Content Newsletter
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Quit & Fit 2.0: Feasibility and Usability Testing
Actual Study Start Date :
Apr 25, 2023
Anticipated Primary Completion Date :
May 24, 2024
Anticipated Study Completion Date :
May 24, 2024

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: 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.

Behavioral: Culturally-tailored Tobacco Treatment
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.

Behavioral: Culturally-tailored Content Newsletters
Weekly newsletters covering topics such as Race and Smoking, Nicotine Replacement Therapy (NRT) Reasons and Motivations for Quitting, Benefits of Quitting and other related topics.

Active Comparator: 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.

Behavioral: Culturally-tailored Tobacco Treatment
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.

Behavioral: Control Preference Scale
Survey to elicit preference on the decision-making interaction with healthcare provider. The survey uses a 5 point scale from 1 to 5 with 1 or 2 points representing Active Control Preference; 3 or 4 representing a Collaborative Control Preference and 5 representing a Passive Control Preference.

Behavioral: Active Content Newsletter or Passive Content Newsletter
Based on the answers to the Control Preference Scale, participants will receive the appropriate weekly newsletter (active content or passive content). Newsletters are covering topics such as Race and Smoking, Nicotine Replacement Therapy (NRT) Reasons and Motivations for Quitting, Benefits of Quitting and other related topics presented in a more passive or active manner.

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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.

Secondary Outcome Measures

  1. Effectiveness of the intervention [Post intervention completion - At 6 weeks]

    Compare the effectiveness 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 on self-reported stage of change for tobacco cessation.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 69 Years
Sexes Eligible for Study:
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hackensack Meridian Health - Center for Discovery and Innovation Nutley New Jersey United States 07110

Sponsors and Collaborators

  • Hackensack Meridian Health

Investigators

  • Principal Investigator: Lisa Carter-Bawa, PhD, Hackensack Meridian Health

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Hackensack Meridian Health
ClinicalTrials.gov Identifier:
NCT05878990
Other Study ID Numbers:
  • Pro2022-0894
First Posted:
May 30, 2023
Last Update Posted:
May 30, 2023
Last Verified:
May 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Hackensack Meridian Health

Study Results

No Results Posted as of May 30, 2023