Trial Outcomes & Findings for Babies Living Safe and Smokefree (NCT NCT02602288)
NCT ID: 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
NA
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
| 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
| 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
| 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=99 Participants
|
30.42 years
STANDARD_DEVIATION 6.64 • n=107 Participants
|
30.11 years
STANDARD_DEVIATION 6.52 • n=206 Participants
|
|
Sex: Female, Male
Female
|
199 Participants
n=99 Participants
|
197 Participants
n=107 Participants
|
396 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
31 Participants
n=99 Participants
|
29 Participants
n=107 Participants
|
60 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
168 Participants
n=99 Participants
|
168 Participants
n=107 Participants
|
336 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
142 Participants
n=99 Participants
|
138 Participants
n=107 Participants
|
280 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
26 Participants
n=99 Participants
|
30 Participants
n=107 Participants
|
56 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
13 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
18 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
36 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
199 participants
n=99 Participants
|
197 participants
n=107 Participants
|
396 participants
n=206 Participants
|
|
Living with spouse/partner
|
74 Participants
n=99 Participants
|
72 Participants
n=107 Participants
|
146 Participants
n=206 Participants
|
|
High school diploma or less
|
124 Participants
n=99 Participants
|
119 Participants
n=107 Participants
|
243 Participants
n=206 Participants
|
|
Other smokers live in home
|
100 Participants
n=99 Participants
|
98 Participants
n=107 Participants
|
198 Participants
n=206 Participants
|
|
Have smoking restrictions in home
|
171 Participants
n=99 Participants
|
176 Participants
n=107 Participants
|
347 Participants
n=206 Participants
|
|
Average cigarettes smoked per day
|
8.83 cigarettes smoked per day
STANDARD_DEVIATION 5.63 • n=99 Participants
|
8.94 cigarettes smoked per day
STANDARD_DEVIATION 5.24 • n=107 Participants
|
8.89 cigarettes smoked per day
STANDARD_DEVIATION 5.43 • n=206 Participants
|
|
Child (log) cotinine
|
.98 log transformed ng/mL
STANDARD_DEVIATION .65 • n=99 Participants
|
.97 log transformed ng/mL
STANDARD_DEVIATION .59 • n=107 Participants
|
.97 log transformed ng/mL
STANDARD_DEVIATION .62 • n=206 Participants
|
|
Problem drinker on TWEAK scale
|
25 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
37 Participants
n=206 Participants
|
|
Meets depression cutoff on CESD
|
90 Participants
n=99 Participants
|
89 Participants
n=107 Participants
|
179 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 3 months and 12 monthsPopulation: 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.
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.
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 monthsPopulation: 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
| 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 assessmentsPopulation: 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
| 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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place