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Completed

NCT Number: NCT05878990

Quit & Fit 2.0: Feasibility and Usability Testing

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.

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Key information

Conditions

Smoking Cessation Behavior Health Behavior Smoking

Age range

18 year–69 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hackensack Meridian Health - Center for Discovery and Innovation

Nutley, New Jersey, 07110, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Culturally-tailored Tobacco Treatment

Behavioral

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.

Culturally-tailored Content Newsletters

Behavioral

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.

Control Preference Scale

Behavioral

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.

Active Content Newsletter or Passive Content Newsletter

Behavioral

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.

Primary outcomes

  1. 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.

  2. 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

  1. Effectiveness of the Intervention (Fagerstrom Test)

    Time frame: 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.

  2. Effectiveness of the Intervention (Expired Air Carbon Monoxide Readings)

    Time frame: 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.

  3. Effectiveness of Intervention

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Hackensack Meridian Health

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 30, 2023
Registry last updated
Oct 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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