Quit & Fit 2.0: Feasibility and Usability Testing

NCT ID: NCT05878990

Last Updated: 2024-10-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-05
• Study Completion Date: 2024-04-30

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.

Conditions

Smoking Cessation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Culturally-tailored Tobacco Treatment

Intervention Type: 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

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

Culturally-tailored Tobacco Treatment

Intervention Type: 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.

Control Preference Scale

Intervention Type: 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

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 69 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Hackensack Meridian Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lisa Carter-Bawa, PhD

Role: PRINCIPAL_INVESTIGATOR

Hackensack Meridian Health

Locations

Hackensack Meridian Health - Center for Discovery and Innovation

Nutley, New Jersey, United States

Countries

United States

References

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

16. Berg CJ, Thomas JL, An LC, et al. Change in smoking, diet, and walking for exercise in blacks. Health Educ Behav. 2012;39(2):191-197. 17. Ussher MH, Taylor AH, Faulkner GE. Exercise interventions for smoking cessation. Cochrane Database Syst Rev. 2014;8:CD002295. 18. Marcus BH, Albrecht AE, Niaura RS, Abrams DB, Thompson PD. Usefulness of physical exercise for maintaining smoking cessation in women. Am J Cardiol. 1991;68(4):406-407. 19. Marcus BH, King TK, Albrecht AE, Parisi AF, Abrams DB. Rationale, design, and baseline data for commit to quit: An exercise efficacy trial for smoking cessation among women. Prev Med. 1997;26(4):586-597. 20. Marcus BH, Albrecht AE, King TK, et al. The efficacy of exercise as an aid for smoking cessation in women: A randomized controlled trial. Arch Intern Med. 1999;159(11):1229-1234. 21. Marcus BH, Albrecht AE, Niaura RS, et al. Exercise enhances the maintenance of smoking cessation in women. Addict Behav. 1995;20(1):87-92. doi: 0306460394000484 [pii]. 22. Marcus BH, Lewis BA, King TK, et al. Rationale, design, and baseline data for commit to quit II: An evaluation of the efficacy of moderate-intensity physical activity as an aid to smoking cessation in women. Prev Med. 2003;36(4):479-492. 23. Whiteley JA, Napolitano MA, Lewis BA, et al. Commit to quit in the YMCAs: Translating an evidence-based quit smoking program for women into a community setting. Nicotine Tob Res. 2007;9(11):1227-1235.

Reference Type: BACKGROUND

24. Webb MS, Baker EA, Rodriguez de Ybarra D. Effects of culturally specific cessation messages on theoretical antecedents of behavior among low-income african american smokers. Psychol Addict Behav. 2010;24(2):333-341. 25. Travier N, Agudo A, May AM, et al. Longitudinal changes in weight in relation to smoking cessation in participants of the EPIC-PANACEA study. Prev Med. 2012;54(3-4):183-192. 26. Filozof C, Fernandez Pinilla MC, Fernandez-Cruz A. Smoking cessation and weight gain. Obes Rev. 2004;5(2):95-103. 27. Grunberg NE. A neurobiological basis for nicotine withdrawal. Proc Natl Acad Sci U S A. 2007;104(46):17901-17902. 28. Mineur YS, Abizaid A, Rao Y, et al. Nicotine decreases food intake through activation of POMC neurons. Science. 2011;332(6035):1330-1332. 29. Seeley RJ, Sandoval DA. Neuroscience: Weight loss through smoking. Nature. 2011;475(7355):176-177. 30. Whittaker R, McRobbie H, Bullen C, Borland R, Rodgers A, Gu Y. Mobile phone-based interventions for smoking cessation. Cochrane Database Syst Rev. 2012;11:CD006611. 31. Stead LF, Perera R, Lancaster T. Telephone counselling for smoking cessation. Cochrane Database Syst Rev. 2006;(3)(3):CD002850. 32. Mottillo S, Filion KB, Belisle P, et al. Behavioural interventions for smoking cessation: A meta-analysis of randomized controlled trials. Eur Heart J. 2009;30(6):718-730. 33. Migneault JP, Dedier JJ, Wright JA, et al. A culturally adapted telecommunication system to improve physical activity, diet quality, and medication adherence among hypertensive african-americans: A randomized controlled trial. Ann Behav Med. 2012;43(1):62-73. 34. Mobile technology fact sheet. http://www.pewinternet.org/fact-sheets/mobile-technology-fact-sheet/. Updated January 2014.

Reference Type: BACKGROUND

Carter-Bawa L, Binstock J, Vielma AG, Shoulders EN, Adams-Campbell L. EmpowerHer-a smoke-free future: a feasibility study examining the feasibility and acceptability of a culturally concordant tobacco treatment intervention in African American women. Pilot Feasibility Stud. 2025 May 31;11(1):75. doi: 10.1186/s40814-025-01664-y.

Reference Type: DERIVED

PMID: 40450357 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Pro2022-0894

Identifier Type: -

Identifier Source: org_study_id