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| Name | Class |
|---|---|
| N.O.R.T.H., Inc. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AAR+Behavioral Intervention (EXP) | Experimental | 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. |
|
| AAR+Attention Control Intervention (CTL) | Active Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ask, Advise, Refer | Behavioral | WIC clinic staff ask about children's secondhand smoke exposure (SHSe), advise about harms of SHSe, and refer to smoking cessation resources |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 months and 12 months |
| 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. | 3 months and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Parent-reported Cotinine-verified 7-day Point Prevalence Abstinence | When a participant reports smoking abstinence, the investigators will bioverify their smoking status. | 7 days prior to 3 month and 12 month assessments |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephen J Lepore, PhD | Temple University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Temple University | Philadelphia | Pennsylvania | 19122 | United States | ||
| N.O.R.T.H., Inc. |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37285107 | Derived | Collins BN, Lepore SJ, Egleston BL. Eliminating children's tobacco smoke exposure: a pathway to bioverified abstinence among low-income maternal smokers in the Babies Living Safe and Smokefree (BLiSS) trial. J Behav Med. 2023 Dec;46(6):1042-1048. doi: 10.1007/s10865-023-00423-9. Epub 2023 Jun 7. | |
| 35196033 | Derived | Collins BN, Lepore SJ, Egleston BL. Multilevel Intervention for Low-Income Maternal Smokers in the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC). Am J Public Health. 2022 Mar;112(3):472-481. doi: 10.2105/AJPH.2021.306601. |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| End of Treatment/3 Month Follow-up |
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| |||||||||||||||||||||
| 12 Month Follow-up |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Mean | Standard Deviation | log transformed ng/mL | 3 months and 12 months |
|
Adverse events were tracked for each participant (enrolled mothers) from the time of the baseline assessment through the 12-month assessment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | AAR+Behavioral Intervention (EXP) | Ask. Advise. Refer (AAR): WIC clinic staff ask mothers 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 parents' 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. |
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Limited generalizability of findings due to high rates of ineligibility (27.7%) and inability to contact (22.7%) among maternal smokers referred to the trial by WIC nutrition professionals who provided the clinic-level intervention.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Stephen Lepore | Temple University | 215-204-9422 | slepore@temple.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Dec 15, 2015 | Aug 28, 2021 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D014029 | Tobacco Use Disorder |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C422209 | corticosteroid hormone-induced factor |
| D012017 | Referral and Consultation |
| D061485 | Tobacco Use Cessation Devices |
| D000074164 | Nicotine Chewing Gum |
| ID | Term |
|---|---|
| D011364 | Professional Practice |
| D009934 | Organization and Administration |
| D006298 | Health Services Administration |
| D013812 | Therapeutics |
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| Telebased tobacco counseling | Behavioral | Telephone counseling to promote parent's smoking cessation and behaviors to protect children from secondhand tobacco smoke |
|
| Telebased nutrition counseling | Behavioral | Telephone counseling to promote nutritious eating practices in the family. |
|
| Mobile phone smoking cessation application | Device | Smartphone based application to support smoking cessation efforts |
|
| Mobile phone nutrition application | Device | Smartphone based application to support healthy eating habits |
|
| Nicotine polacrilex | Drug | Over the counter nicotine replacement therapy in gum or lozenge form. |
|
|
| Philadelphia |
| Pennsylvania |
| 19132 |
| United States |
| 34255698 | Derived | Lepore SJ, Collins BN, Killam HW, Barry B. Supportive Accountability and Mobile App Use in a Tobacco Control Intervention Targeting Low-Income Minority Mothers Who Smoke: Observational Study. JMIR Mhealth Uhealth. 2021 Jul 2;9(7):e28175. doi: 10.2196/28175. |
| 28288601 | Derived | Collins BN, Lepore SJ. Babies Living Safe & Smokefree: randomized controlled trial of a multilevel multimodal behavioral intervention to reduce low-income children's tobacco smoke exposure. BMC Public Health. 2017 Mar 14;17(1):249. doi: 10.1186/s12889-017-4145-7. |
| Withdrawn - refused treatment |
|
| NOT COMPLETED |
|
|
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Living with spouse/partner | Count of Participants | Participants |
|
| High school diploma or less | Count of Participants | Participants |
|
| Other smokers live in home | Count of Participants | Participants |
|
| Have smoking restrictions in home | Count of Participants | Participants |
|
| Average cigarettes smoked per day | Mean | Standard Deviation | cigarettes smoked per day |
|
| Child (log) cotinine | Mean | Standard Deviation | log transformed ng/mL |
|
| Problem drinker on TWEAK scale | The TWEAK alcohol screening test is a short, five-question test that was originally designed to screen pregnant women for harmful drinking habits. The name of the test is an acronym for tolerance, worried, eye-opener, amnesia, and k/cut down (with a poetic license use of "K" instead of "C" for cutting down on alcohol consumption). A total score of two or more on the test is an indication of harmful drinking and further evaluation is indicated. | Count of Participants | Participants |
|
| Meets depression cutoff on CESD | A score greater than or equal to 10 indicates significant distress or a positive screen for depression. | Count of Participants | Participants |
|
| OG001 | 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 |
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | Cigarettes/day secondhand smoke exposure | 3 months and 12 months |
|
|
|
| Secondary | Parent-reported Cotinine-verified 7-day Point Prevalence Abstinence | When a participant reports smoking abstinence, the investigators will bioverify their smoking status. | The number of participants analyzed reflects number of people completing assessment plus recoding participants who were lost to follow up as 0 = not quit. | Posted | Count of Participants | Participants | 7 days prior to 3 month and 12 month assessments |
|
|
|
| 0 |
| 199 |
| 0 |
| 199 |
| 0 |
| 199 |
| EG001 | AAR+Attention Control Intervention (CTL) | Ask. Advise. Refer (AAR): WIC clinic staff ask mothers 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 | 0 | 197 | 0 | 197 | 0 | 197 |
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| D002638 | Chewing Gum |
| D053149 | Plant Gums |
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D002182 | Candy |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
| 12 month follow-up |
|
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| 12 month follow-up |
|
|