Environmental Tobacco Smoke, Smoking Cessation
Conditions
Brief summary
The purpose of this study was to explore the potential for directly targeting smoking cessation, regardless of motivation level, in a subsample of neonatal intensive care unit (NICU) parents with the ultimate goal of reducing secondhand smoke (SHS) in their homes.
Interventions
DRUGnicotine replacement therapy (NRT)
Participants were provided with either 2 weeks of 14-mg or 21-mg transdermal nicotine patches for every smoker in the home
BEHAVIORALmotivational advice
Received two in-hospital motivational advice sessions by a research associate (RA). The RA adapted session content from a previous tobacco-smoke exposure protocol
BEHAVIORALQuitline referral
Quitline participants received information about tobacco-smoke exposure reduction and a referral to a tobacco Quitline.
Sponsors
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
* Eligible mothers of any age or ethnic background must have an infant that is at least 1 week prior to the estimated date of hospital discharge in the NICU (ensuring time for the intervention) * report that a household resident smokes at least 5 cigarettes per day, on average, within the 2 months preceding the screening visit * agree to attend intervention sessions * live within 50 miles of our center * and have access to a telephone
Exclusion criteria
* Mothers were ineligible if they met criteria for severe cognitive, and/or psychiatric impairment, per judgment of NICU and research staff, that precludes cooperation with study protocol * were unable to read, write, and speak English * were unable or unwilling to provide signed consent for participation * and were unable or unwilling to meet study requirements for data collection and intervention purposes. * Within the month immediately preceding the screening visit, use of any form of tobacco or nicotine products other than cigarettes (e.g., e-cigarettes, chewing tobacco, etc.) on 3 or more days within a week if the individual refuses to refrain from such tobacco use during the course of the study * Current use of NRT or enrollment (or plans to enroll) in another smoking cessation program in the next 3 months * Uncontrolled hypertension (systolic blood pressure \[SBP\] greater than 180 or diastolic blood pressure \[DBP\] greater than 110) * History of severe cardiovascular (stroke, heart attack), kidney (e.g. chronic or acute kidney failure) or liver disease, or other unstable disease in the last 3 months * History of hypersensitivity or allergic reaction to NRT or similar chemical classes or any component of these formulations (including allergy to latex)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility as Assessed by Number of Participants Who Accepted NRT Patches From Research Staff. | From time of randomization to intervention session number 2 (generally completed within 2-3 weeks of randomization) |
| Efficacy as Assessed by the Number of Participants Who Reported That Anyone in Their Household Used NRT. | From time of randomization to follow-up visit #2 (generally completed within 2-3 months) |
Secondary
| Measure | Time frame |
|---|---|
| Cigarette Use (Point Prevalence), as Measured by Number of Cigarettes Smoked Per Day by Other Household Members (Other Than the Participant or Participant's Partner) | baseline |
| Smoking Quit Attempts, as Measured by Number of Participants Who Reported One or Greater Quit Attempts | at the time of follow-up visit #1 (about 2 weeks post-intervention) |
| Smoking Quit Attempts, as Measured by Number of Participant's Partners Who Reported One or Greater Quit Attempts | at the time of follow-up visit #1 (about 2 weeks post-intervention) |
| Cigarette Use (Point Prevalence), as Measured by Number of Cigarettes Smoked Per Day by the Participant | Baseline |
| Home Smoking Ban Status, as Measured by Number of Participants Who Report a Home-smoking Ban. | From time of randomization to follow-up visit #2 (generally completed within 2-3 months) |
| Car Smoking Ban Status, as Measured by Number of Participants Who Report a Car-smoking Ban. | From time of randomization to follow-up visit #2 (generally completed within 2-3 months) |
| Smoking Quit Attempts, as Measured by Number of Other Household Members (Other Than the Participant or the Participant's Partner) Who Reported One or Greater Quit Attempts | at the time of follow-up visit #1 (about 2 weeks post-intervention) |
| Cigarette Use (Point Prevalence), as Measured by Number of Cigarettes Smoked Per Day by the Participant's Partner | baseline |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Motivational Advice and Free NRT nicotine replacement therapy (NRT): Participants were provided with 2 weeks of either 14-mg or 21-mg transdermal nicotine patches for every smoker in the home
motivational advice: Received two in-hospital motivational advice sessions by a research associate (RA). | 16 |
| Quitline Referral Quitline referral: Quitline participants received information about tobacco-smoke exposure reduction and a referral to a tobacco Quitline. | 16 |
| Total | 32 |
Baseline characteristics
| Characteristic | Motivational Advice and Free NRT | Quitline Referral | Total |
|---|---|---|---|
| Age, Continuous | 30.6 years STANDARD_DEVIATION 9.7 | 29.9 years STANDARD_DEVIATION 4.3 | 30.2 years STANDARD_DEVIATION 6.8 |
| Race/Ethnicity, Customized Asian | 1 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Black/African-America | 9 Participants | 9 Participants | 18 Participants |
| Race/Ethnicity, Customized Hispanic | 3 Participants | 2 Participants | 5 Participants |
| Race/Ethnicity, Customized White, non-Hispanic | 3 Participants | 4 Participants | 7 Participants |
| Region of Enrollment United States | 16 Participants | 16 Participants | 32 Participants |
| Sex: Female, Male Female | 15 Participants | 16 Participants | 31 Participants |
| Sex: Female, Male Male | 1 Participants | 0 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 16 | 0 / 16 |
| other Total, other adverse events | 0 / 16 | 0 / 16 |
| serious Total, serious adverse events | 0 / 16 | 0 / 16 |
Outcome results
Primary
Efficacy as Assessed by the Number of Participants Who Reported That Anyone in Their Household Used NRT.
Time frame: From time of randomization to follow-up visit #2 (generally completed within 2-3 months)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Motivational Advice and Free NRT | Efficacy as Assessed by the Number of Participants Who Reported That Anyone in Their Household Used NRT. | 6 Participants |
| Quitline Referral | Efficacy as Assessed by the Number of Participants Who Reported That Anyone in Their Household Used NRT. | 2 Participants |
Primary
Feasibility as Assessed by Number of Participants Who Accepted NRT Patches From Research Staff.
Time frame: From time of randomization to intervention session number 2 (generally completed within 2-3 weeks of randomization)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Motivational Advice and Free NRT | Feasibility as Assessed by Number of Participants Who Accepted NRT Patches From Research Staff. | 13 Participants |
Secondary
Car Smoking Ban Status, as Measured by Number of Participants Who Report a Car-smoking Ban.
Time frame: From time of randomization to follow-up visit #2 (generally completed within 2-3 months)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Motivational Advice and Free NRT | Car Smoking Ban Status, as Measured by Number of Participants Who Report a Car-smoking Ban. | 14 Participants |
| Quitline Referral | Car Smoking Ban Status, as Measured by Number of Participants Who Report a Car-smoking Ban. | 14 Participants |
Secondary
Cigarette Use (Point Prevalence), as Measured by Number of Cigarettes Smoked Per Day by Other Household Members (Other Than the Participant or Participant's Partner)
Time frame: baseline
Population: Only current smokers were assessed for this measure. 7 household members (other than participant or partner) living with participant in the Motivational Advice and Free NRT arm reported current smoking, and 6 household members (other than participant or partner) living with participant in the Quitline Referral arm reported current smoking.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Motivational Advice and Free NRT | Cigarette Use (Point Prevalence), as Measured by Number of Cigarettes Smoked Per Day by Other Household Members (Other Than the Participant or Participant's Partner) | <10 cigarettes per day | 5 Participants |
| Motivational Advice and Free NRT | Cigarette Use (Point Prevalence), as Measured by Number of Cigarettes Smoked Per Day by Other Household Members (Other Than the Participant or Participant's Partner) | >=10 cigarettes per day | 2 Participants |
| Quitline Referral | Cigarette Use (Point Prevalence), as Measured by Number of Cigarettes Smoked Per Day by Other Household Members (Other Than the Participant or Participant's Partner) | <10 cigarettes per day | 3 Participants |
| Quitline Referral | Cigarette Use (Point Prevalence), as Measured by Number of Cigarettes Smoked Per Day by Other Household Members (Other Than the Participant or Participant's Partner) | >=10 cigarettes per day | 3 Participants |
Secondary
Cigarette Use (Point Prevalence), as Measured by Number of Cigarettes Smoked Per Day by the Participant
Time frame: Baseline
Population: Only current smokers (at Baseline) were assessed on this measure; 2 reported current smoking (Motivational Advice and Free NRT arm); 3 reported current smoking (Quitline Referral arm). A 4th Quitline participant began smoking after data were collected; therefore, number of cigarettes/day at baseline was not collected for this 4th participant.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Motivational Advice and Free NRT | Cigarette Use (Point Prevalence), as Measured by Number of Cigarettes Smoked Per Day by the Participant | <10 cigarettes per day | 2 Participants |
| Motivational Advice and Free NRT | Cigarette Use (Point Prevalence), as Measured by Number of Cigarettes Smoked Per Day by the Participant | >=10 cigarettes per day | 0 Participants |
| Quitline Referral | Cigarette Use (Point Prevalence), as Measured by Number of Cigarettes Smoked Per Day by the Participant | <10 cigarettes per day | 2 Participants |
| Quitline Referral | Cigarette Use (Point Prevalence), as Measured by Number of Cigarettes Smoked Per Day by the Participant | >=10 cigarettes per day | 1 Participants |
Secondary
Cigarette Use (Point Prevalence), as Measured by Number of Cigarettes Smoked Per Day by the Participant's Partner
Time frame: baseline
Population: Only current smokers were assessed for this measure. 12 partners of participants in the Motivational Advice and Free NRT arm reported current smoking, and 12 partners of participants in the Quitline Referral arm reported current smoking.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Motivational Advice and Free NRT | Cigarette Use (Point Prevalence), as Measured by Number of Cigarettes Smoked Per Day by the Participant's Partner | <10 cigarettes per day | 6 Participants |
| Motivational Advice and Free NRT | Cigarette Use (Point Prevalence), as Measured by Number of Cigarettes Smoked Per Day by the Participant's Partner | >=10 cigarettes per day | 6 Participants |
| Quitline Referral | Cigarette Use (Point Prevalence), as Measured by Number of Cigarettes Smoked Per Day by the Participant's Partner | <10 cigarettes per day | 7 Participants |
| Quitline Referral | Cigarette Use (Point Prevalence), as Measured by Number of Cigarettes Smoked Per Day by the Participant's Partner | >=10 cigarettes per day | 5 Participants |
Secondary
Home Smoking Ban Status, as Measured by Number of Participants Who Report a Home-smoking Ban.
Time frame: From time of randomization to follow-up visit #2 (generally completed within 2-3 months)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Motivational Advice and Free NRT | Home Smoking Ban Status, as Measured by Number of Participants Who Report a Home-smoking Ban. | 14 Participants |
| Quitline Referral | Home Smoking Ban Status, as Measured by Number of Participants Who Report a Home-smoking Ban. | 14 Participants |
Secondary
Smoking Quit Attempts, as Measured by Number of Other Household Members (Other Than the Participant or the Participant's Partner) Who Reported One or Greater Quit Attempts
Time frame: at the time of follow-up visit #1 (about 2 weeks post-intervention)
Population: For the Motivational advice and free NRT arm, 7 household members (other than the participant or the participant's partner) reported current smoking at baseline. For the Motivational advice and free NRT arm, 6 household members (other than the participant or the participant's partner) reported current smoking at baseline.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Motivational Advice and Free NRT | Smoking Quit Attempts, as Measured by Number of Other Household Members (Other Than the Participant or the Participant's Partner) Who Reported One or Greater Quit Attempts | 0 Participants |
| Quitline Referral | Smoking Quit Attempts, as Measured by Number of Other Household Members (Other Than the Participant or the Participant's Partner) Who Reported One or Greater Quit Attempts | 0 Participants |
Secondary
Smoking Quit Attempts, as Measured by Number of Other Household Members (Other Than the Participant or the Participant's Partner) Who Reported One or Greater Quit Attempts
Time frame: at the time of follow-up visit #2 (about 1 month post-intervention)
Population: For the Motivational advice and free NRT arm, 7 household members (other than the participant or the participant's partner) reported current smoking at baseline. For the Motivational advice and free NRT arm, 6 household members (other than the participant or the participant's partner) reported current smoking at baseline.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Motivational Advice and Free NRT | Smoking Quit Attempts, as Measured by Number of Other Household Members (Other Than the Participant or the Participant's Partner) Who Reported One or Greater Quit Attempts | 0 Participants |
| Quitline Referral | Smoking Quit Attempts, as Measured by Number of Other Household Members (Other Than the Participant or the Participant's Partner) Who Reported One or Greater Quit Attempts | 0 Participants |
Secondary
Smoking Quit Attempts, as Measured by Number of Participant's Partners Who Reported One or Greater Quit Attempts
Time frame: at the time of follow-up visit #1 (about 2 weeks post-intervention)
Population: For each arm, 12 partners reported current smoking at baseline.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Motivational Advice and Free NRT | Smoking Quit Attempts, as Measured by Number of Participant's Partners Who Reported One or Greater Quit Attempts | 5 Participants |
| Quitline Referral | Smoking Quit Attempts, as Measured by Number of Participant's Partners Who Reported One or Greater Quit Attempts | 0 Participants |
Secondary
Smoking Quit Attempts, as Measured by Number of Participant's Partners Who Reported One or Greater Quit Attempts
Time frame: at the time of follow-up visit #2 (about 1 month post-intervention)
Population: For each arm, 12 partners reported current smoking at baseline.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Motivational Advice and Free NRT | Smoking Quit Attempts, as Measured by Number of Participant's Partners Who Reported One or Greater Quit Attempts | 2 Participants |
| Quitline Referral | Smoking Quit Attempts, as Measured by Number of Participant's Partners Who Reported One or Greater Quit Attempts | 1 Participants |
Secondary
Smoking Quit Attempts, as Measured by Number of Participants Who Reported One or Greater Quit Attempts
Time frame: at the time of follow-up visit #2 (about 1 month post-intervention)
Population: Only participants who reported current smoking were assessed for this measure. 2 participants in the Motivational Advice and Free NRT arm reported current smoking, and 4 participants in the Quitline Referral arm reported current smoking (between baseline and the follow-up visit #2; i.e., 1 Quitline participant began smoking after baseline).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Motivational Advice and Free NRT | Smoking Quit Attempts, as Measured by Number of Participants Who Reported One or Greater Quit Attempts | 1 Participants |
| Quitline Referral | Smoking Quit Attempts, as Measured by Number of Participants Who Reported One or Greater Quit Attempts | 4 Participants |
Secondary
Smoking Quit Attempts, as Measured by Number of Participants Who Reported One or Greater Quit Attempts
Time frame: at the time of follow-up visit #1 (about 2 weeks post-intervention)
Population: Only participants who reported current smoking were assessed for this measure. 2 participants in the Motivational Advice and Free NRT arm reported current smoking, and 4 participants in the Quitline Referral arm reported current smoking (between baseline and the follow-up visit #1; i.e., 1 Quitline participant began smoking after baseline).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Motivational Advice and Free NRT | Smoking Quit Attempts, as Measured by Number of Participants Who Reported One or Greater Quit Attempts | 2 Participants |
| Quitline Referral | Smoking Quit Attempts, as Measured by Number of Participants Who Reported One or Greater Quit Attempts | 1 Participants |