Trial Outcomes & Findings for Babies Living Safe and Smokefree (NCT NCT02602288)

Last Updated: 2022-03-15

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

396 participants

Primary outcome timeframe

3 months and 12 months

Results posted on

2022-03-15

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	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.	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
End of Treatment/3 Month Follow-up STARTED	199	197
End of Treatment/3 Month Follow-up COMPLETED	174	179
End of Treatment/3 Month Follow-up NOT COMPLETED	25	18
12 Month Follow-up STARTED	174	179
12 Month Follow-up COMPLETED	172	175
12 Month Follow-up NOT COMPLETED	2	4

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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
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
12 Month Follow-up Lost to Follow-up	0	4
12 Month Follow-up Withdrawal by Subject	2	0

Baseline Characteristics

Babies Living Safe and Smokefree

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	AAR+Behavioral Intervention (EXP) n=199 Participants 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.	AAR+Attention Control Intervention (CTL) n=197 Participants 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	Total n=396 Participants Total of all reporting groups
Age, Continuous	29.81 years STANDARD_DEVIATION 6.40 • n=5 Participants	30.42 years STANDARD_DEVIATION 6.64 • n=7 Participants	30.11 years STANDARD_DEVIATION 6.52 • n=5 Participants
Sex: Female, Male Female	199 Participants n=5 Participants	197 Participants n=7 Participants	396 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	31 Participants n=5 Participants	29 Participants n=7 Participants	60 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	168 Participants n=5 Participants	168 Participants n=7 Participants	336 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	142 Participants n=5 Participants	138 Participants n=7 Participants	280 Participants n=5 Participants
Race (NIH/OMB) White	26 Participants n=5 Participants	30 Participants n=7 Participants	56 Participants n=5 Participants
Race (NIH/OMB) More than one race	13 Participants n=5 Participants	11 Participants n=7 Participants	24 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	18 Participants n=5 Participants	18 Participants n=7 Participants	36 Participants n=5 Participants
Region of Enrollment United States	199 participants n=5 Participants	197 participants n=7 Participants	396 participants n=5 Participants
Living with spouse/partner	74 Participants n=5 Participants	72 Participants n=7 Participants	146 Participants n=5 Participants
High school diploma or less	124 Participants n=5 Participants	119 Participants n=7 Participants	243 Participants n=5 Participants
Other smokers live in home	100 Participants n=5 Participants	98 Participants n=7 Participants	198 Participants n=5 Participants
Have smoking restrictions in home	171 Participants n=5 Participants	176 Participants n=7 Participants	347 Participants n=5 Participants
Average cigarettes smoked per day	8.83 cigarettes smoked per day STANDARD_DEVIATION 5.63 • n=5 Participants	8.94 cigarettes smoked per day STANDARD_DEVIATION 5.24 • n=7 Participants	8.89 cigarettes smoked per day STANDARD_DEVIATION 5.43 • n=5 Participants
Child (log) cotinine	.98 log transformed ng/mL STANDARD_DEVIATION .65 • n=5 Participants	.97 log transformed ng/mL STANDARD_DEVIATION .59 • n=7 Participants	.97 log transformed ng/mL STANDARD_DEVIATION .62 • n=5 Participants
Problem drinker on TWEAK scale	25 Participants n=5 Participants	12 Participants n=7 Participants	37 Participants n=5 Participants
Meets depression cutoff on CESD	90 Participants n=5 Participants	89 Participants n=7 Participants	179 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	AAR+Behavioral Intervention (EXP) n=168 Participants 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.	AAR+Attention Control Intervention (CTL) n=174 Participants 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
Child Urine Cotinine 3 month follow-up	1.00 log transformed ng/mL Standard Deviation 0.67	.97 log transformed ng/mL Standard Deviation .63
Child Urine Cotinine 12 month follow-up	1.09 log transformed ng/mL Standard Deviation 0.73	1.00 log transformed ng/mL Standard Deviation 0.68

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	AAR+Behavioral Intervention (EXP) n=172 Participants 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.	AAR+Attention Control Intervention (CTL) n=178 Participants 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
Cigarettes/Day 3 month follow-up	3.00 Cigarettes/day secondhand smoke exposure Standard Deviation 4.89	4.47 Cigarettes/day secondhand smoke exposure Standard Deviation 6.08
Cigarettes/Day 12 month follow-up	3.03 Cigarettes/day secondhand smoke exposure Standard Deviation 5.14	3.81 Cigarettes/day secondhand smoke exposure Standard Deviation 5.04

SECONDARY outcome

Timeframe: 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.

When a participant reports smoking abstinence, the investigators will bioverify their smoking status.

Outcome measures

Outcome measures
Measure	AAR+Behavioral Intervention (EXP) n=174 Participants 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.	AAR+Attention Control Intervention (CTL) n=179 Participants 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
Parent-reported Cotinine-verified 7-day Point Prevalence Abstinence 3 month follow-up	14 Participants	2 Participants
Parent-reported Cotinine-verified 7-day Point Prevalence Abstinence 12 month follow-up	15 Participants	7 Participants

Adverse Events

AAR+Behavioral Intervention (EXP)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

AAR+Attention Control Intervention (CTL)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Stephen Lepore

Temple University

Phone: 215-204-9422

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place