Second Hand Tobacco Smoke, Nicotine Dependence
Conditions
Brief summary
The purpose of this randomized controlled trial is to develop and test the efficacy of a multilevel, multimodal intervention designed to modify maternal smoking behavior to reduce children's exposure to secondhand tobacco smoke (primary outcome) and promote their smoking cessation (secondary outcome). Low-income mothers who smoke will be enrolled. Mothers will be recruited from the supplemental nutrition program, Women, Infants and Children (WIC) clinics. All mothers visiting WIC clinics will receive a clinic-level intervention, which consists of nutrition counselors following an ask, advise, and refer protocol to identify if their children are exposed to secondhand tobacco smoke, advise mothers who smoke about the harms of such exposure and the benefits of reducing exposure, and referring mothers to the trial. Screened eligible mothers will be consented and randomized to an attention control condition focused on nutrition (CTL) or to an experimental (EXP) multimodal behavioral intervention that integrates telebased counseling to promote the reduction of child secondhand smoke exposure (SHSE) and maternal smoking with an adjunct smoking cessation mobile app and nicotine replacement therapy use. The investigators will test the primary hypothesis that relative to children in the CTL condition, those in the EXP condition will have lower exposure SHSE as measured by mothers' reports and child cotinine levels. The investigators will also test the secondary hypothesis that relative to mothers in the CTL condition, those in the EXP condition will have higher bioverified 7-day point prevalence quit rates. In addition, the study will: (a) evaluate if specific psychosocial and behavioral factors-- social support, urge coping skills, self-efficacy, and SHSe protective behaviors--mediate the effects of the EXP intervention on outcomes and (b) explore whether other residential smokers, level of nicotine dependence, depressive/anxious symptoms, weight concerns, intervention dosage, and pregnancy status predict outcomes and moderate treatment effects.
Interventions
BEHAVIORALAsk, Advise, Refer
WIC clinic staff ask about children's secondhand smoke exposure (SHSe), advise about harms of SHSe, and refer to smoking cessation resources
BEHAVIORALTelebased tobacco counseling
Telephone counseling to promote parent's smoking cessation and behaviors to protect children from secondhand tobacco smoke
BEHAVIORALTelebased nutrition counseling
Telephone counseling to promote nutritious eating practices in the family.
DEVICEMobile phone smoking cessation application
Smartphone based application to support smoking cessation efforts
DEVICEMobile phone nutrition application
Smartphone based application to support healthy eating habits
Over the counter nicotine replacement therapy in gum or lozenge form.
Sponsors
N.O.R.T.H., Inc.
Temple University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* English speaking * female * at least 18 years of age * parent or legal guardian of child under 6 yrs old who lives with them at least 4 days/wk * smokes
Exclusion criteria
* non-nicotine drug dependence * active psychiatric disturbance (bipolar, schizophrenia, psychosis) * inadequate health literacy * pregnant * no smartphone
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Child Urine Cotinine | 3 months and 12 months | Child urine cotinine is a biomarker for assessing secondhand smoke exposure. The investigators anticipate the EXP group will evidence a greater reduction in child urine cotinine over time than the CTL group. Cotinine values were log transformed to normalize distributions. |
| Cigarettes/Day | 3 months and 12 months | Parental report of cigarettes child is exposed to each day in the home and car and other locations by all sources during the 7 days prior to assessment. The investigators anticipate the EXP group will evidence greater reductions in child secondhand smoke exposure over time than the CTL group. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Parent-reported Cotinine-verified 7-day Point Prevalence Abstinence | 7 days prior to 3 month and 12 month assessments | When a participant reports smoking abstinence, the investigators will bioverify their smoking status. |
Countries
United States
Participant flow
Recruitment details
Nutrition professionals at 10 of Philadelphia's Women, Infants and Children (WIC) clinics conducted the Ask, Advise, Refer protocol to refer women to the study from February of 2016 to October of 2018.
Pre-assignment details
A total of 2846 women were referred to the trial: 788 were not eligible, 647 were never reached for screening, and 709 declined to be screened. Of 702 that screened eligible, 104 refused consent and 202 could not be reached for consent or baseline. A total of 396 participants were randomized between the two arms of the study.
Participants by arm
| Arm | Count |
|---|---|
| AAR+Behavioral Intervention (EXP) Ask Advise Refer (AAR): WIC clinic staff ask about children's secondhand smoke exposure (SHSe), advise about harms of SHSe, and refer to smoking cessation resources. Telebased tobacco counseling: Telephone counseling to promote parent's smoking cessation and behaviors to protect children from secondhand tobacco smoke. Mobile phone smoking cessation application: Smartphone based application to support smoking cessation efforts. Nicotine polacrilex: Over the counter nicotine replacement therapy in gum or lozenge form.
Ask, Advise, Refer: WIC clinic staff ask about children's secondhand smoke exposure (SHSe), advise about harms of SHSe, and refer to smoking cessation resources
Telebased tobacco counseling: Telephone counseling to promote parent's smoking cessation and behaviors to protect children from secondhand tobacco smoke
Mobile phone smoking cessation application: Smartphone based application to support smoking cessation efforts
Nicotine polacrilex: Over the counter nicotine replacement therapy in gum or lozenge form. | 199 |
| AAR+Attention Control Intervention (CTL) Ask Advise Refer (AAR): WIC clinic staff ask about children's secondhand smoke exposure (SHSe), advise about harms of SHSe, and refer to smoking cessation resources. Telebased nutrition counseling: Telephone counseling to promote nutritious eating practices in the family. Mobile phone nutrition application: Smartphone based application to support healthy eating habits
Ask, Advise, Refer: WIC clinic staff ask about children's secondhand smoke exposure (SHSe), advise about harms of SHSe, and refer to smoking cessation resources
Telebased nutrition counseling: Telephone counseling to promote nutritious eating practices in the family.
Mobile phone nutrition application: Smartphone based application to support healthy eating habits | 197 |
| Total | 396 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| 12 Month Follow-up | Lost to Follow-up | 0 | 4 |
| 12 Month Follow-up | Withdrawal by Subject | 2 | 0 |
| End of Treatment/3 Month Follow-up | Lost to Follow-up | 14 | 10 |
| End of Treatment/3 Month Follow-up | Withdrawal by Subject | 2 | 2 |
| End of Treatment/3 Month Follow-up | Withdrawn - refused treatment | 9 | 6 |
Baseline characteristics
| Characteristic | AAR+Behavioral Intervention (EXP) | AAR+Attention Control Intervention (CTL) | Total |
|---|---|---|---|
| Age, Continuous | 29.81 years STANDARD_DEVIATION 6.4 | 30.42 years STANDARD_DEVIATION 6.64 | 30.11 years STANDARD_DEVIATION 6.52 |
| Average cigarettes smoked per day | 8.83 cigarettes smoked per day STANDARD_DEVIATION 5.63 | 8.94 cigarettes smoked per day STANDARD_DEVIATION 5.24 | 8.89 cigarettes smoked per day STANDARD_DEVIATION 5.43 |
| Child (log) cotinine | .98 log transformed ng/mL STANDARD_DEVIATION 0.65 | .97 log transformed ng/mL STANDARD_DEVIATION 0.59 | .97 log transformed ng/mL STANDARD_DEVIATION 0.62 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 31 Participants | 29 Participants | 60 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 168 Participants | 168 Participants | 336 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Have smoking restrictions in home | 171 Participants | 176 Participants | 347 Participants |
| High school diploma or less | 124 Participants | 119 Participants | 243 Participants |
| Living with spouse/partner | 74 Participants | 72 Participants | 146 Participants |
| Meets depression cutoff on CESD | 90 Participants | 89 Participants | 179 Participants |
| Other smokers live in home | 100 Participants | 98 Participants | 198 Participants |
| Problem drinker on TWEAK scale | 25 Participants | 12 Participants | 37 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 142 Participants | 138 Participants | 280 Participants |
| Race (NIH/OMB) More than one race | 13 Participants | 11 Participants | 24 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 18 Participants | 18 Participants | 36 Participants |
| Race (NIH/OMB) White | 26 Participants | 30 Participants | 56 Participants |
| Region of Enrollment United States | 199 participants | 197 participants | 396 participants |
| Sex: Female, Male Female | 199 Participants | 197 Participants | 396 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 / 199 | 0 / 197 |
| other Total, other adverse events | 0 / 199 | 0 / 197 |
| serious Total, serious adverse events | 0 / 199 | 0 / 197 |
Outcome results
Primary
Child Urine Cotinine
Child urine cotinine is a biomarker for assessing secondhand smoke exposure. The investigators anticipate the EXP group will evidence a greater reduction in child urine cotinine over time than the CTL group. Cotinine values were log transformed to normalize distributions.
Time frame: 3 months and 12 months
Population: At 12 month follow-up the greater number of units analyzed compared to participants analyzed in the treatment group relates to increased participant compliance with providing a urine sample. At all timepoints the fewer number of cotinines collected compared to self-report data reflects non-compliance among some participants to provide a urine sample following the telephone self-report assessments.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AAR+Behavioral Intervention (EXP) | Child Urine Cotinine | 3 month follow-up | 1.00 log transformed ng/mL | Standard Deviation 0.67 |
| AAR+Behavioral Intervention (EXP) | Child Urine Cotinine | 12 month follow-up | 1.09 log transformed ng/mL | Standard Deviation 0.73 |
| AAR+Attention Control Intervention (CTL) | Child Urine Cotinine | 3 month follow-up | .97 log transformed ng/mL | Standard Deviation 0.63 |
| AAR+Attention Control Intervention (CTL) | Child Urine Cotinine | 12 month follow-up | 1.00 log transformed ng/mL | Standard Deviation 0.68 |
Primary
Cigarettes/Day
Parental report of cigarettes child is exposed to each day in the home and car and other locations by all sources during the 7 days prior to assessment. The investigators anticipate the EXP group will evidence greater reductions in child secondhand smoke exposure over time than the CTL group.
Time frame: 3 months and 12 months
Population: The lower number of participants analyzed for this item compared to the number of participants completing this assessment battery is due to non-compliance in completing this item among some participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AAR+Behavioral Intervention (EXP) | Cigarettes/Day | 3 month follow-up | 3.00 Cigarettes/day secondhand smoke exposure | Standard Deviation 4.89 |
| AAR+Behavioral Intervention (EXP) | Cigarettes/Day | 12 month follow-up | 3.03 Cigarettes/day secondhand smoke exposure | Standard Deviation 5.14 |
| AAR+Attention Control Intervention (CTL) | Cigarettes/Day | 3 month follow-up | 4.47 Cigarettes/day secondhand smoke exposure | Standard Deviation 6.08 |
| AAR+Attention Control Intervention (CTL) | Cigarettes/Day | 12 month follow-up | 3.81 Cigarettes/day secondhand smoke exposure | Standard Deviation 5.04 |
Secondary
Parent-reported Cotinine-verified 7-day Point Prevalence Abstinence
When a participant reports smoking abstinence, the investigators will bioverify their smoking status.
Time frame: 7 days prior to 3 month and 12 month assessments
Population: The number of participants analyzed reflects number of people completing assessment plus recoding participants who were lost to follow up as 0 = not quit.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| AAR+Behavioral Intervention (EXP) | Parent-reported Cotinine-verified 7-day Point Prevalence Abstinence | 3 month follow-up | 14 Participants |
| AAR+Behavioral Intervention (EXP) | Parent-reported Cotinine-verified 7-day Point Prevalence Abstinence | 12 month follow-up | 15 Participants |
| AAR+Attention Control Intervention (CTL) | Parent-reported Cotinine-verified 7-day Point Prevalence Abstinence | 3 month follow-up | 2 Participants |
| AAR+Attention Control Intervention (CTL) | Parent-reported Cotinine-verified 7-day Point Prevalence Abstinence | 12 month follow-up | 7 Participants |