- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05878990
Quit & Fit 2.0: Feasibility and Usability Testing
January 5, 2024 updated by: Hackensack Meridian Health
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.
Study Overview
Status
Recruiting
Conditions
Study Type
Interventional
Enrollment (Estimated)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Francis Valenzona
- Phone Number: (201) 880 - 3400
- Email: francis.valenzona@hmh-cdi.org
Study Locations
-
-
New Jersey
-
Nutley, New Jersey, United States, 07110
- Recruiting
- Hackensack Meridian Health - Center for Discovery and Innovation
-
Contact:
- Francis Valenzona
- Phone Number: 201-880-3400
- Email: francis.valenzona@hmh-cdi.org
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
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.
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.
|
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.
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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Post intervention completion - At 6 weeks
|
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.
|
Post intervention completion - At 6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Effectiveness of the intervention
Time Frame: 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.
|
Post intervention completion - At 6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Lisa Carter-Bawa, PhD, Hackensack Meridian Health
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 25, 2023
Primary Completion (Estimated)
May 24, 2024
Study Completion (Estimated)
May 24, 2024
Study Registration Dates
First Submitted
May 18, 2023
First Submitted That Met QC Criteria
May 18, 2023
First Posted (Actual)
May 30, 2023
Study Record Updates
Last Update Posted (Estimated)
January 8, 2024
Last Update Submitted That Met QC Criteria
January 5, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- Pro2022-0894
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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