Clinical trial NCT05878990: Quit & Fit 2.0: Feasibility and Usability Testing
Official title: Quit & Fit 2.0: Feasibility and Usability Testing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Keywords: smoking
smoking cessation
smoking behavior
culturally tailored tobacco cessation intervention
Lead sponsor: Hackensack Meridian Health
Sponsor class: OTHER
First posted: 2023-05-30
Enrollment: 22
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Feasibility of the 6-week Tobacco Treatment Intervention
timeFrame: Post intervention completion - At 6 weeks
measure: Accessibility and Satisfaction of the 6-week Tobacco Treatment Intervention
timeFrame: Post intervention completion - At 6 weeks
Secondary outcomes:
measure: Effectiveness of the Intervention (Fagerstrom Test)
timeFrame: Post intervention completion - At 6 weeks
measure: Effectiveness of the Intervention (Expired Air Carbon Monoxide Readings)
timeFrame: 6 weeks post intervention
measure: Effectiveness of Intervention
timeFrame: 6 weeks post intervention
Other outcomes:
Locations:
city: Nutley
country: United States
facility: Hackensack Meridian Health - Center for Discovery and Innovation
state: New Jersey
Study officials:
affiliation: Hackensack Meridian Health
name: Lisa Carter-Bawa, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 1. Ries LAG, Melbert D, Krapcho M. SEER cancer statistics review, 1975-2005. 2008. 2. American Cancer Society. Cancer facts and figures for African Americans: 2022. 3. Siegel R, Naishadham D, Jemal A. Cancer statistics, 2021. CA Cancer J Clin. 2021;62(1):10-29. 4. Singh GK, Williams SD, Siahpush M, Mulhollen A. Socioeconomic, rural-urban, and racial inequalities in US cancer mortality: Part I-all cancers and lung cancer and part II-colorectal, prostate, breast, and cervical cancers. J Cancer Epidemiol. 2011;2011:107497. 5. Haiman CA, Stram DO, Wilkens LR, et al. Ethnic and racial differences in the smoking-related risk of lung cancer. N Engl J Med. 2006;354(4):333-342. 6. Wang Y, Beydoun MA. The obesity epidemic in the united states--gender, age, socioeconomic, racial/ethnic, and geographic characteristics: A systematic review and meta-regression analysis. Epidemiol Rev. 2007;29:6-28. 7. Roger VL, Go AS, Lloyd-Jones DM, et al. Heart disease and stroke statistics--2012 update: A report from the american heart association. Circulation. 2012;125(1):e2-e220.
citation: 8. Dubowitz T, Heron M, Bird CE, et al. Neighborhood socioeconomic status and fruit and vegetable intake among whites, blacks, and mexican americans in the united states. Am J Clin Nutr. 2008;87(6):1883-1891. 9. U.S. physical activity statistics: 2007 state demographic data comparison. 2008. 10. Marshall SJ, Jones DA, Ainsworth BE, Reis JP, Levy SS, Macera CA. Race/ethnicity, social class, and leisure-time physical inactivity. Med Sci Sports Exerc. 2007;39(1):44-51. 11. Bassuk SS, Manson JE. Physical activity and cardiovascular disease prevention in women: A review of the epidemiologic evidence. Nutr Metab Cardiovasc Dis. 2010;20(6):467-473. 12. Glasgow RE, Lichtenstein E, Marcus AC. Why don't we see more translation of health promotion research to practice? rethinking the efficacy-to-effectiveness transition. Am J Public Health. 2003;93(8):1261-1267. 13. Swan GE, Ward MM, Carmelli D, Jack LM. Differential rates of relapse in subgroups of male and female smokers. J Clin Epidemiol. 1993;46(9):1041-1053. 14. Pirie PL, Murray DM, Luepker RV. Gender differences in cigarette smoking and quitting in a cohort of young adults. Am J Public Health. 1991;81(3):324-327. 15. Pomerleau CS, Zucker AN, Namenek Brouwer RJ, Pomerleau OF, Stewart AJ. Race differences in weight concerns among women smokers: Results from two independent samples. Addict Behav. 2001;26(5):651-663.
citation: 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.
citation: 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.