Smoking Cessation Intervention in Public Housing

Cigarette Smoking Clinical Trial

Official title:

Social Ecological Based Smoking Cessation Intervention in Public Housing Neighborhoods

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01035151
• Other study ID #: MUS08022834
• Secondary ID: R01HL090951
• Status: Completed
• Phase: N/A
• Start date: July 2009
• Est. completion date: May 15, 2018

Study information

• Verified date: November 2018
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The major aim of this study is to test the effectiveness of a bundled, multi-level intervention (Sister to Sister) on smoking cessation outcomes in female smokers residing in public housing neighborhoods.

Hypothesis 1.1: As compared to the control group, women receiving the Sister to Sister Intervention will have higher 7-day point prevalence quit rates at 6- and 12-months as validated by salivary cotinine.

Hypothesis 1.2: As compared to the control group, women receiving the Sister to Sister Intervention will have higher 6- and 12-month prolonged smoking abstinence as validated by salivary cotinine.

Description:

This was a cluster randomized controlled study evaluating the effect of a multi-level intervention, Sister to Sister, on the smoking cessation in two Southeastern US metropolitan areas. Fourteen subsidized housing neighborhoods, eight in Charleston, SC and six in Augusta, GA, were pair matched based on size; with one neighborhood in each pair randomized to the intervention to ensure balanced recruitment between groups. Neighborhoods ranged in size from 22 to 33 participants with a total sample size of 409 women; neighborhoods were chosen as the primary sampling unit to prevent contamination of the outcome within neighborhoods, with women in the neighborhoods as secondary sampling unit. All statistical analyses were conducted using SAS 9.2 (SAS Institute, Cary, NC) with statistical significance at an alpha level of 0.05. Comparison between groups at baseline used t-tests for continuous variables and chi-square tests for categorical variables. The primary outcome of interest was smoking status which was dichotomized (smoker/non-smoker) at the 6 and 12 month measurements. Smoking status was determined by cotinine levels in saliva with non-smokers defined as those with cotinine levels of 14 ng/mL or less.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 420
• Est. completion date: May 15, 2018
• Est. primary completion date: May 15, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 yrs of age and older,

• female, resident of public housing, daily smoker

Exclusion Criteria:

• pregnant,

• breastfeeding,

• no intentions to quit smoking

Related Conditions & MeSH terms

• Cigarette Smoking

Intervention

Behavioral:
• Experimental
Neighborhood level interventions, peer group (counseling, NRT), and individual level (Coach/CHW)
• Control
Written Cessation Materials

Locations

Country	Name	City	State
United States	Medical College of Georgia	Augusta	Georgia
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of South Carolina	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

References & Publications (7)

Andrews JO, Mueller M, Dooley M, Newman SD, Magwood GS, Tingen MS. Effect of a smoking cessation intervention for women in subsidized neighborhoods: A randomized controlled trial. Prev Med. 2016 Sep;90:170-6. doi: 10.1016/j.ypmed.2016.07.008. Epub 2016 Ju — View Citation

Andrews JO, Mueller M, Newman SD, Magwood G, Ahluwalia JS, White K, Tingen MS. The association of individual and neighborhood social cohesion, stressors, and crime on smoking status among African-American women in southeastern US subsidized housing neighborhoods. J Urban Health. 2014 Dec;91(6):1158-74. doi: 10.1007/s11524-014-9911-6. — View Citation

Andrews JO, Newman SD, Heath J, Williams LB, Tingen MS. Community-based participatory research and smoking cessation interventions: a review of the evidence. Nurs Clin North Am. 2012 Mar;47(1):81-96. doi: 10.1016/j.cnur.2011.10.013. Epub 2011 Dec 14. Review. — View Citation

Andrews JO, Tingen MS, Jarriel SC, Caleb M, Simmons A, Brunson J, Mueller M, Ahluwalia JS, Newman SD, Cox MJ, Magwood G, Hurman C. Application of a CBPR framework to inform a multi-level tobacco cessation intervention in public housing neighborhoods. Am J Community Psychol. 2012 Sep;50(1-2):129-40. doi: 10.1007/s10464-011-9482-6. — View Citation

Magwood GS, Andrews JO, Zapka J, Cox MJ, Newman S, Stuart GW. Institutionalization of community partnerships: the challenge for academic health centers. J Health Care Poor Underserved. 2012 Nov;23(4):1512-26. doi: 10.1353/hpu.2012.0161. — View Citation

Newman SD, Andrews JO, Magwood GS, Jenkins C, Cox MJ, Williamson DC. Community advisory boards in community-based participatory research: a synthesis of best processes. Prev Chronic Dis. 2011 May;8(3):A70. Epub 2011 Apr 15. — View Citation

Spruill IJ, Leite RS, Fernandes JK, Kamen DL, Ford ME, Jenkins C, Hunt KJ, Andrews JO. Successes, Challenges and Lessons Learned: Community-engaged research with South Carolina's Gullah population. Gateways. 2013;6. doi: 10.5130/ijcre.v6i1.2805. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Abstinent From Smoking	Reported abstinence validated by exhaled CO and saliva cotinine	12 month