Cigarette Smoking
Conditions
Keywords
randomized cluster design, tobacco cessation, smoking cessation, African American
Brief 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.
Detailed 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.
Interventions
BEHAVIORALExperimental
Neighborhood level interventions, peer group (counseling, NRT), and individual level (Coach/CHW)
BEHAVIORALControl
Written Cessation Materials
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
Medical University of South Carolina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 yrs of age and older, * female, resident of public housing, daily smoker
Exclusion criteria
* pregnant, * breastfeeding, * no intentions to quit smoking
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Abstinent From Smoking | 12 month | Reported abstinence validated by exhaled CO and saliva cotinine |
Countries
United States
Participant flow
Recruitment details
Of the 34 subsidized housing neighborhoods in these two regions, the study was implemented in the 14 neighborhoods that met eligibility. Seven matched pairs were formed and randomly assigned one neighborhood in each pair to either the treatment condition or a delayed control condition. 27-32 participants enrolled in each neighborhood.
Pre-assignment details
Common reasons for exclusions were not a resident of the neighborhood, not an active smokers.
Participants by arm
| Arm | Count |
|---|---|
| Delayed Control Women in the delayed control condition received culturally sensitive smoking cessation written materials at week 1, and mailed materials at week 6, 12, and 18. At the end of the study (i.e., after the 12 month data collection), participants were offered counseling, nicotine patches, and community health worker contacts.
Control: Written Cessation Materials | 209 |
| Experimental Women in neighborhoods randomized to the S2S received 24-week bundled multi-level intervention. Individual-led strategies were led by paid community health workers (CHWs). The CHWs provided 1:1 contact to reinforce social support, and enhanced self-efficacy with cessation attempts. A certified smoking cessation counselor led behavioral group sessions using the S2S handbook based on the PHS Guidelines. The weekly group sessions were initiated during the 1st week of the intervention, with a total of 6 group sessions over a 6-week period. Transdermal nicotine patches were offered to participants who set a quit date. Within the 24-week study period, the neighborhood tenant association, in partnership with study staff, implemented at least two neighborhood level anti-smoking activities
Experimental: Neighborhood level interventions, peer group (counseling, NRT), and individual level (Coach/CHW) | 200 |
| Total | 409 |
Baseline characteristics
| Characteristic | Delayed Control | Experimental | Total |
|---|---|---|---|
| Age, Continuous | 43 years STANDARD_DEVIATION 15.6 | 41 years STANDARD_DEVIATION 14.1 | 42 years STANDARD_DEVIATION 14 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 4 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 190 Participants | 180 Participants | 370 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 16 Participants | 16 Participants | 32 Participants |
| Nicotine Dependence Score | 4.8 units on a scale STANDARD_DEVIATION 2.2 | 4.7 units on a scale STANDARD_DEVIATION 2.2 | 4.7 units on a scale STANDARD_DEVIATION 2.2 |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 192 Participants | 157 Participants | 349 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 13 Participants | 15 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 11 Participants | 28 Participants | 39 Participants |
| Region of Enrollment United States | 209 Participants | 200 Participants | 409 Participants |
| Sex: Female, Male Female | 209 Participants | 200 Participants | 409 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 209 | 0 / 200 |
| other Total, other adverse events | 0 / 209 | 0 / 200 |
| serious Total, serious adverse events | 0 / 209 | 0 / 200 |
Outcome results
Primary
Number of Participants Abstinent From Smoking
Reported abstinence validated by exhaled CO and saliva cotinine
Time frame: 12 month
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Delayed Control | Number of Participants Abstinent From Smoking | 10 Participants |
| Experimental | Number of Participants Abstinent From Smoking | 24 Participants |