Identify the Usefulness of Peer-facilitated Versus Self-navigated Quit Tobacco Program for Youths.

NCT06053762 | Recruiting DMC

• 2 other identifiers: IRB number: #23/04-00935U54MD013376
• Study Type: interventional
• Target: 630
• Locations: 1 country
• Sites: 1

Brief Summary

The proposed study is a randomized clinical trial. The overarching goal of the study is to apply Community Based Participatory Research (CBPR) to reduce tobacco use among youth and young adults (14-21 y/o) in Baltimore City through a mixed-method approach adapted to the needs of youth and young adults. This study has partnered with the American Lung Association's Not On Tobacco (N-O-T) program and aims to deliver tobacco cessation classes. The study will target Baltimore City high schools and colleges, prioritizing facilities in underserved inner-city communities. The proposed research consists of a 2-arm trial where participants from four high schools and two colleges will be randomized to peer-facilitated tobacco cessation classes or self-navigated groups. The trial aims to assess the effectiveness of peer-facilitated tobacco cessation intervention compared to self-navigated tobacco cessation in terms of their success rates (quitting and staying quit). The study's primary hypothesis is that the tobacco cessation rate will be equal to or higher in the peer-facilitated arm than in the self-navigated arms. The secondary hypothesis is that the retention rate will be equal to or higher in the peer-facilitated arm compared to the self-navigated arm. CEASE Youth tobacco cessation program is an eight-week program based on the American Lung Association's (ALA) Not On Tobacco (N-O-T) program. The ALA's N-OT program is acknowledged as an accessible and effective option for teen tobacco cessation. Participants in the peer-facilitated group will be given the evidence-based N-O-T program curriculum and provided with virtual materials, information, and resources by their assigned peer facilitators. Virtual tobacco cessation peer motivation sessions will be offered using the digital online platform Zoom, and the peer facilitators will communicate with the participants in between the classes. The participants in the self-navigated group will receive the same ALA N-O-T program curriculum and complete the eight-week sessions, but it will be self-navigated and without peer facilitations. No peer facilitator will be assigned to this group, and the participants will complete the curriculum by themselves. They will also receive other available resources, including information about the local tobacco cessation services available.

Conditions

Tobacco Product Use

Keywords

Tobacco cessation program, Community-based participatory research, Peer-facilitated approach, Youth

Outcome Measures

Primary Outcomes (1)

• Self-reported tobacco cessation

  Self-reported smoking status is a reliable, validated, and widely used measure.

  Self-reported tobacco cessation: 3-5 months post-intervention.

Secondary Outcomes (1)

• Retention rate

  Week 8

Study Arms (2)

Peer-facilitated tobacco cessation

EXPERIMENTAL

Peer-facilitated tobacco cessation: Participants will be given the evidence-based N-O-T program curriculum for tobacco cessation classes and provided with virtual materials, information, and resources by their assigned peer facilitators. Virtual tobacco cessation peer motivation sessions will be offered using the digital online platform Zoom, and the peer facilitators will communicate with the participants in between the classes Peer-facilitated tobacco cessation: Participants will be given the evidence-based N-O-T program curriculum for tobacco cessation classes and provided with virtual materials, information, and resources by their assigned peer facilitators. Virtual tobacco cessation peer motivation sessions will be offered using the digital online platform Zoom, and the peer facilitators will communicate with the participants in between the classes.

Behavioral: Peer-facilitated tobacco cessation

Self-navigated tobacco cessation

OTHER

Self-navigated tobacco cessation: The participants in the self-navigated group will receive the same ALA N-O-T program curriculum and complete the eight-week sessions, but it will be self-navigated and without peer facilitations. No peer facilitator will be assigned to this group and the participants will complete the curriculum by themselves.

Behavioral: Self-navigated tobacco cessation

Interventions

Peer-facilitated tobacco cessation BEHAVIORAL

Peer-facilitated tobacco cessation: Participants will be given the evidence-based N-O-T program curriculum for tobacco cessation classes and provided with virtual materials, information, and resources by their assigned peer facilitators. Virtual tobacco cessation peer motivation sessions will be offered using the digital online platform Zoom, and the peer facilitators will communicate with the participants in between the classes

Peer-facilitated tobacco cessation

Self-navigated tobacco cessation BEHAVIORAL

Self-navigated tobacco cessation: The participants in the self-navigated group will receive the same ALA N-O-T program curriculum and will complete the eight-week sessions, but it will be self-navigated and without peer facilitations. No peer facilitator will be assigned to this group and the participants will complete the curriculum by themselves. Self-navigated tobacco cessation: The participants in the self-navigated group will receive the same ALA N-O-T program curriculum and will complete the eight-week sessions, but it will be self-navigated and without peer facilitations. No peer facilitator will be assigned to this group and the participants will complete the curriculum by themselves.

Self-navigated tobacco cessation

Eligibility Criteria

• Age: 14 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Current tobacco user (have used any tobacco product over the past 30 days)
• Individuals who are 14- 21 years old
• Individuals who are ready and willing to quit using tobacco
• Individuals who have access to a digital device (e.g., laptop/computer/tablet) with internet access or data

You may not qualify if:

• Individuals who have health conditions preventing them from providing consent will be excluded from the study.

Sponsors & Collaborators

• Morgan State University: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (1)

Morgan CARES

Baltimore, Maryland, 21213, United States

RECRUITING

Related Publications (28)

• CDCTobaccoFree. Burden of Tobacco Use in the U.S. Centers for Disease Control and Prevention. Published August 8, 2022. Accessed April 9, 2023. https://www.cdc.gov/tobacco/campaign/tips/resources/data/cigarette-smoking-in-united-states.html

  BACKGROUND

• National Center for Chronic Disease Prevention and Health Promotion (US) Office on Smoking and Health. The Health Consequences of Smoking-50 Years of Progress: A Report of the Surgeon General. Atlanta (GA): Centers for Disease Control and Prevention (US); 2014. Available from http://www.ncbi.nlm.nih.gov/books/NBK179276/

  PMID: 24455788 BACKGROUND

• Park-Lee E, Ren C, Cooper M, Cornelius M, Jamal A, Cullen KA. Tobacco Product Use Among Middle and High School Students - United States, 2022. MMWR Morb Mortal Wkly Rep. 2022 Nov 11;71(45):1429-1435. doi: 10.15585/mmwr.mm7145a1.

  PMID: 36355596 BACKGROUND

• Sun R, Mendez D, Warner KE. Trends in Nicotine Product Use Among US Adolescents, 1999-2020. JAMA Netw Open. 2021 Aug 2;4(8):e2118788. doi: 10.1001/jamanetworkopen.2021.18788.

  PMID: 34432013 BACKGROUND

• Ford P, Clifford A, Gussy K, Gartner C. A systematic review of peer-support programs for smoking cessation in disadvantaged groups. Int J Environ Res Public Health. 2013 Oct 28;10(11):5507-22. doi: 10.3390/ijerph10115507.

  PMID: 24169412 BACKGROUND

• McKay CE, Dickerson F. Peer Supports for Tobacco Cessation for Adults with Serious Mental Illness: A Review of the Literature. J Dual Diagn. 2012;8(2):104-112. doi: 10.1080/15504263.2012.670847. Epub 2012 May 11.

  PMID: 22904697 BACKGROUND

• O'Toole TP, Aaron KF, Chin MH, Horowitz C, Tyson F. Community-based participatory research: opportunities, challenges, and the need for a common language. J Gen Intern Med. 2003 Jul;18(7):592-4. doi: 10.1046/j.1525-1497.2003.30416.x. No abstract available.

  PMID: 12848844 BACKGROUND

• Wallerstein, Nina, Duran, Bonnie, Oetzel, John G. and Minkler, Meredith. Community-Based Participatory Research for Health: Advancing Social and Health Equity, 3rd Edition | Wiley. Wiley.com. Accessed April 9, 2023. https://www.wiley.com/en-us/Community+Based+Participatory+Research+for+Health%3A+Advancing+Social+and+Health+Equity%2C+3rd+Edition-p-9781119258858

  BACKGROUND

• Prado GF, Lombardi EM, Bussacos MA, Arrabal-Fernandes FL, Terra-Filho M, Santos Ude P. A real-life study of the effectiveness of different pharmacological approaches to the treatment of smoking cessation: re-discussing the predictors of success. Clinics (Sao Paulo). 2011;66(1):65-71. doi: 10.1590/s1807-59322011000100012.

  PMID: 21437438 BACKGROUND

• Jain A. Treating nicotine addiction. BMJ. 2003 Dec 13;327(7428):1394-5. doi: 10.1136/bmj.327.7428.1394. No abstract available.

  PMID: 14670889 BACKGROUND

• Raw M, McNeill A, West R. Smoking cessation: evidence based recommendations for the healthcare system. BMJ. 1999 Jan 16;318(7177):182-5. doi: 10.1136/bmj.318.7177.182. No abstract available.

  PMID: 9888919 BACKGROUND

• CDCTobaccoFree. About the Office on Smoking and Health. Centers for Disease Control and Prevention. Published December 2, 2021. Accessed April 9, 2023. https://www.cdc.gov/tobacco/about/osh/index.htm

  BACKGROUND

• Ramo DE, Liu H, Prochaska JJ. A mixed-methods study of young adults' receptivity to using Facebook for smoking cessation: if you build it, will they come? Am J Health Promot. 2015 Mar-Apr;29(4):e126-35. doi: 10.4278/ajhp.130326-QUAL-128. Epub 2014 Feb 27.

  PMID: 24575728 BACKGROUND

• Ranney L, Melvin C, Lux L, McClain E, Lohr KN. Systematic review: smoking cessation intervention strategies for adults and adults in special populations. Ann Intern Med. 2006 Dec 5;145(11):845-56. doi: 10.7326/0003-4819-145-11-200612050-00142. Epub 2006 Sep 5.

  PMID: 16954352 BACKGROUND

• Elfeddali I, Bolman C, Candel MJ, Wiers RW, De Vries H. The role of self-efficacy, recovery self-efficacy, and preparatory planning in predicting short-term smoking relapse. Br J Health Psychol. 2012 Feb;17(1):185-201. doi: 10.1111/j.2044-8287.2011.02032.x. Epub 2011 Jun 27.

  PMID: 22107073 BACKGROUND

• Bandura A. Social cognitive theory: an agentic perspective. Annu Rev Psychol. 2001;52:1-26. doi: 10.1146/annurev.psych.52.1.1.

  PMID: 11148297 BACKGROUND

• Wang TW, Gentzke A, Sharapova S, Cullen KA, Ambrose BK, Jamal A. Tobacco Product Use Among Middle and High School Students - United States, 2011-2017. MMWR Morb Mortal Wkly Rep. 2018 Jun 8;67(22):629-633. doi: 10.15585/mmwr.mm6722a3.

  PMID: 29879097 BACKGROUND

• Centers for Disease Control and Prevention (CDC). Tobacco product use among middle and high school students--United States, 2011 and 2012. MMWR Morb Mortal Wkly Rep. 2013 Nov 15;62(45):893-7.

  PMID: 24226625 BACKGROUND

• Corey CG, Ambrose BK, Apelberg BJ, King BA. Flavored Tobacco Product Use Among Middle and High School Students--United States, 2014. MMWR Morb Mortal Wkly Rep. 2015 Oct 2;64(38):1066-70. doi: 10.15585/mmwr.mm6438a2.

  PMID: 26421418 BACKGROUND

• CDCTobaccoFree. Youth and Tobacco Use. Centers for Disease Control and Prevention. Published November 9, 2022. Accessed April 9, 2023. https://www.cdc.gov/tobacco/data_statistics/fact_sheets/youth_data/tobacco_use/index.htm

  BACKGROUND

• Wagner FA, Sheikhattari P, Buccheri J, Gunning M, Bleich L, Schutzman C. A Community-Based Participatory Research on Smoking Cessation Intervention for Urban Communities. J Health Care Poor Underserved. 2016;27(1):35-50. doi: 10.1353/hpu.2016.0017.

  PMID: 27763459 BACKGROUND

• Sheikhattari P, Zhu S, Clubb PA. New Insights on Tobacco Smoking among the Underserved and Poor. World Academy of Science, Engineering, and Technology. Published online January 1, 2010.

  BACKGROUND

• Sheikhattari P, Apata J, Kamangar F, Schutzman C, O'Keefe A, Buccheri J, Wagner FA. Examining Smoking Cessation in a Community-Based Versus Clinic-Based Intervention Using Community-Based Participatory Research. J Community Health. 2016 Dec;41(6):1146-1152. doi: 10.1007/s10900-016-0264-9.

  PMID: 27688221 BACKGROUND

• Estreet A, Apata J, Kamangar F, Schutzman C, Buccheri J, O'Keefe AM, Wagner F, Sheikhattari P. Improving Participants' Retention in a Smoking Cessation Intervention Using a Community-based Participatory Research Approach. Int J Prev Med. 2017 Dec 19;8:106. doi: 10.4103/ijpvm.IJPVM_303_17. eCollection 2017.

  PMID: 29416835 BACKGROUND

• Human Subjects Research Ethics Field Training Guide | Johns Hopkins | Bloomberg School of Public Health. Accessed April 9, 2023. https://publichealth.jhu.edu/offices-and-services/institutional-review-board-irb/training/human-subjects-research-ethics-field-training-guide

  BACKGROUND

• Cheung KL, de Ruijter D, Hiligsmann M, Elfeddali I, Hoving C, Evers SMAA, de Vries H. Exploring consensus on how to measure smoking cessation. A Delphi study. BMC Public Health. 2017 Nov 21;17(1):890. doi: 10.1186/s12889-017-4902-7.

  PMID: 29162043 BACKGROUND

• Moberg J, Kramer M. A brief history of the cluster randomised trial design. J R Soc Med. 2015 May;108(5):192-8. doi: 10.1177/0141076815582303. No abstract available.

  PMID: 26022551 BACKGROUND

• Prokhorov AV, Khalil GE, Foster DW, Marani SK, Guindani M, Espada JP, Gonzalvez MT, Idrisov B, Galimov A, Arora M, Tewari A, Isralowitz R, Lapvongwatana P, Chansatitporn N, Chen X, Zheng H, Sussman S. Testing the nicotine dependence measure mFTQ for adolescent smokers: A multinational investigation. Am J Addict. 2017 Oct;26(7):689-696. doi: 10.1111/ajad.12583. Epub 2017 Jul 14.

  PMID: 28708935 BACKGROUND

Central Study Contacts

Payam Sheikhattari, MD, MPH

CONTACT

443-885-3639; payam.sheikhattari@morgan.edu

Emma Mitchell, MSW

CONTACT

443 885 3626; emma.mitchell@morgan.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 19, 2023
• First Posted: September 26, 2023
• Study Start: October 1, 2023
• Primary Completion: September 1, 2024
• Study Completion: December 1, 2024
• Last Updated: March 29, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)