Trial Outcomes & Findings for Behavioral and Enhanced Perinatal Intervention for Cessation (B-EPIC): Reducing Tobacco Use Among Opioid Addicted Women (NCT NCT03796208)
NCT ID: NCT03796208
Last Updated: 2022-07-15
Results Overview
Participants will be asked during the second trimester, third trimester, two months postpartum and six months postpartum (up to 50 weeks) to self-report the number of cigarettes smoked per day. Data will be presented as the change in the number of cigarettes smoked per day compared between groups.
COMPLETED
NA
78 participants
up to 50 weeks (third trimester (28-36.6 weeks gestation) minus first postpartum visit (2-8.6 weeks after delivery))
2022-07-15
Participant Flow
Number of individuals consented and further screened for eligibility = 79; Number of participants randomized to intervention = 40; Number of participants randomized to treatment as usual = 38
Participants may have been excluded prior to randomization for the following reason: 1\. Withdrawal (changed mind)
Participant milestones
| Measure |
Tobacco Intervention
Participants in this group will be randomized to the Behavioral and Enhanced Perinatal Intervention for Cessation (B-EPIC) intervention.
Behavioral and Enhanced Perinatal Intervention for Cessation (B-EPIC): Women enrolled in the intervention group will receive TAU plus B-EPIC, which includes four core components: 1) Individualized tobacco treatment plus supplemental counseling, 2) Biomarker validation and feedback, 3) Change in maternal thought process and adoption of healthy behavior (e.g. exercise, based on PI framework), and 4) Pharmacotherapy as needed (see Table 3 for a summary of the study design). The initial assessment for this intervention takes 60 minutes, with follow-up sessions typically lasting 15-20 minutes. All sessions occur prior to or after pre-scheduled perinatal appointments. The intervention will be led by a certified tobacco treatment specialist (CTTS).
|
Treatment As Usual
Participants in this group will be randomized to tobacco treatment as usual.
Treatment As Usual: Women enrolled in the control group are informed of the risks of tobacco use and benefits of quitting using the ACOG 5'A's approach by their healthcare provider. This standard takes approximately 5-15 minutes, and is offered at each prenatal and postpartum appointment. The five steps of the ACOG recommendation are: 1.) Ask about tobacco use, 2.) Advise to quit, 3.) Assess willingness to make a quit attempt, 4.) Assist in quit attempt, and 5.) Arrange follow-up. The provider may also talk to the participant about nicotine replacement therapy.
|
|---|---|---|
|
Overall Study
STARTED
|
40
|
38
|
|
Overall Study
COMPLETED
|
16
|
16
|
|
Overall Study
NOT COMPLETED
|
24
|
22
|
Reasons for withdrawal
| Measure |
Tobacco Intervention
Participants in this group will be randomized to the Behavioral and Enhanced Perinatal Intervention for Cessation (B-EPIC) intervention.
Behavioral and Enhanced Perinatal Intervention for Cessation (B-EPIC): Women enrolled in the intervention group will receive TAU plus B-EPIC, which includes four core components: 1) Individualized tobacco treatment plus supplemental counseling, 2) Biomarker validation and feedback, 3) Change in maternal thought process and adoption of healthy behavior (e.g. exercise, based on PI framework), and 4) Pharmacotherapy as needed (see Table 3 for a summary of the study design). The initial assessment for this intervention takes 60 minutes, with follow-up sessions typically lasting 15-20 minutes. All sessions occur prior to or after pre-scheduled perinatal appointments. The intervention will be led by a certified tobacco treatment specialist (CTTS).
|
Treatment As Usual
Participants in this group will be randomized to tobacco treatment as usual.
Treatment As Usual: Women enrolled in the control group are informed of the risks of tobacco use and benefits of quitting using the ACOG 5'A's approach by their healthcare provider. This standard takes approximately 5-15 minutes, and is offered at each prenatal and postpartum appointment. The five steps of the ACOG recommendation are: 1.) Ask about tobacco use, 2.) Advise to quit, 3.) Assess willingness to make a quit attempt, 4.) Assist in quit attempt, and 5.) Arrange follow-up. The provider may also talk to the participant about nicotine replacement therapy.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
0
|
|
Overall Study
Loss of pregnancy
|
1
|
1
|
|
Overall Study
Changed prenatal clinics
|
0
|
5
|
|
Overall Study
Lost to Follow-up
|
20
|
16
|
Baseline Characteristics
Behavioral and Enhanced Perinatal Intervention for Cessation (B-EPIC): Reducing Tobacco Use Among Opioid Addicted Women
Baseline characteristics by cohort
| Measure |
Tobacco Intervention
n=38 Participants
Participants in this group will be randomized to the Behavioral and Enhanced Perinatal Intervention for Cessation (B-EPIC) intervention.
Behavioral and Enhanced Perinatal Intervention for Cessation (B-EPIC): Women enrolled in the intervention group will receive TAU plus B-EPIC, which includes four core components: 1) Individualized tobacco treatment plus supplemental counseling, 2) Biomarker validation and feedback, 3) Change in maternal thought process and adoption of healthy behavior (e.g. exercise, based on PI framework), and 4) Pharmacotherapy as needed (see Table 3 for a summary of the study design). The initial assessment for this intervention takes 60 minutes, with follow-up sessions typically lasting 15-20 minutes. All sessions occur prior to or after pre-scheduled perinatal appointments. The intervention will be led by a certified tobacco treatment specialist (CTTS).
|
Treatment As Usual
n=38 Participants
Participants in this group will be randomized to tobacco treatment as usual.
Treatment As Usual: Women enrolled in the control group are informed of the risks of tobacco use and benefits of quitting using the ACOG 5'A's approach by their healthcare provider. This standard takes approximately 5-15 minutes, and is offered at each prenatal and postpartum appointment. The five steps of the ACOG recommendation are: 1.) Ask about tobacco use, 2.) Advise to quit, 3.) Assess willingness to make a quit attempt, 4.) Assist in quit attempt, and 5.) Arrange follow-up. The provider may also talk to the participant about nicotine replacement therapy.
|
Total
n=76 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
38 Participants
n=99 Participants
|
38 Participants
n=107 Participants
|
76 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
30.9 years
n=99 Participants
|
30.8 years
n=107 Participants
|
30.9 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
38 Participants
n=99 Participants
|
38 Participants
n=107 Participants
|
76 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
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
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
33 Participants
n=99 Participants
|
35 Participants
n=107 Participants
|
68 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
38 Participants
n=99 Participants
|
38 Participants
n=107 Participants
|
76 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: up to 50 weeks (third trimester (28-36.6 weeks gestation) minus first postpartum visit (2-8.6 weeks after delivery))Population: Overall number of participants analyzed in each Group is based on number of participants with cigarettes smoked per day data available at third trimester (28-36.6 weeks gestation) minus first postpartum visit (2-8.6 weeks after delivery) to determine a change. Enrollment (up to 31.6 weeks gestation) was not used in this analysis due to a change in the data collection format from categorical to continuous. Disruptions by COVID-19 created many challenges with longitudinal data collection.
Participants will be asked during the second trimester, third trimester, two months postpartum and six months postpartum (up to 50 weeks) to self-report the number of cigarettes smoked per day. Data will be presented as the change in the number of cigarettes smoked per day compared between groups.
Outcome measures
| Measure |
Tobacco Intervention
n=15 Participants
Participants in this group will be randomized to the Behavioral and Enhanced Perinatal Intervention for Cessation (B-EPIC) intervention.
Behavioral and Enhanced Perinatal Intervention for Cessation (B-EPIC): Women enrolled in the intervention group will receive TAU plus B-EPIC, which includes four core components: 1) Individualized tobacco treatment plus supplemental counseling, 2) Biomarker validation and feedback, 3) Change in maternal thought process and adoption of healthy behavior (e.g. exercise, based on PI framework), and 4) Pharmacotherapy as needed (see Table 3 for a summary of the study design). The initial assessment for this intervention takes 60 minutes, with follow-up sessions typically lasting 15-20 minutes. All sessions occur prior to or after pre-scheduled perinatal appointments. The intervention will be led by a certified tobacco treatment specialist (CTTS).
|
Treatment As Usual
n=18 Participants
Participants in this group will be randomized to tobacco treatment as usual.
Treatment As Usual: Women enrolled in the control group are informed of the risks of tobacco use and benefits of quitting using the ACOG 5'A's approach by their healthcare provider. This standard takes approximately 5-15 minutes, and is offered at each prenatal and postpartum appointment. The five steps of the ACOG recommendation are: 1.) Ask about tobacco use, 2.) Advise to quit, 3.) Assess willingness to make a quit attempt, 4.) Assist in quit attempt, and 5.) Arrange follow-up. The provider may also talk to the participant about nicotine replacement therapy.
|
|---|---|---|
|
Change in the Number of Cigarettes Smoked Per Day
|
0 cigarettes per day
Interval -10.0 to 5.0
|
0 cigarettes per day
Interval -5.0 to 3.0
|
PRIMARY outcome
Timeframe: up to 50 weeks (enrollment (up to 31.6 weeks gestation) minus first postpartum visit (2-8.6 weeks after delivery))Population: Overall number of participants analyzed in each Group is based on the number of participants with cotinine levels data available at enrollment (up to 31.6 weeks gestation) minus first postpartum visit (2-8.6 weeks after delivery) to determine a change in the level of urine cotinine using NICALERT, an immunochromatographic assay test strip (Nymox Pharmaceutical Corporation, Montreal, Quebec). Disruptions caused by COVID-19 created many challenges in longitudinal data collection.
Participants will provide a urine sample to be measured by litmus analysis during the second trimester, third trimester, two months postpartum and six months postpartum (up to 50 weeks). The litmus levels range from 0 (minimum) to 6 (maximum). Data will be presented as the change in cotinine levels by the litmus measure over the course of the study compared between groups.
Outcome measures
| Measure |
Tobacco Intervention
n=22 Participants
Participants in this group will be randomized to the Behavioral and Enhanced Perinatal Intervention for Cessation (B-EPIC) intervention.
Behavioral and Enhanced Perinatal Intervention for Cessation (B-EPIC): Women enrolled in the intervention group will receive TAU plus B-EPIC, which includes four core components: 1) Individualized tobacco treatment plus supplemental counseling, 2) Biomarker validation and feedback, 3) Change in maternal thought process and adoption of healthy behavior (e.g. exercise, based on PI framework), and 4) Pharmacotherapy as needed (see Table 3 for a summary of the study design). The initial assessment for this intervention takes 60 minutes, with follow-up sessions typically lasting 15-20 minutes. All sessions occur prior to or after pre-scheduled perinatal appointments. The intervention will be led by a certified tobacco treatment specialist (CTTS).
|
Treatment As Usual
n=24 Participants
Participants in this group will be randomized to tobacco treatment as usual.
Treatment As Usual: Women enrolled in the control group are informed of the risks of tobacco use and benefits of quitting using the ACOG 5'A's approach by their healthcare provider. This standard takes approximately 5-15 minutes, and is offered at each prenatal and postpartum appointment. The five steps of the ACOG recommendation are: 1.) Ask about tobacco use, 2.) Advise to quit, 3.) Assess willingness to make a quit attempt, 4.) Assist in quit attempt, and 5.) Arrange follow-up. The provider may also talk to the participant about nicotine replacement therapy.
|
|---|---|---|
|
Change in Urine Cotinine Concentration Level
|
-0.09 litmus levels
Standard Deviation 0.68
|
0.17 litmus levels
Standard Deviation 0.56
|
PRIMARY outcome
Timeframe: up to 50 weeks (enrollment (up to 31.6 weeks gestation) minus first postpartum visit (2-8.6 weeks after delivery))Population: Overall number of participants analyzed in each Group is based on the number of participants with self-report electronic cigarette (e-cig) usage per day and with data available at study time points enrollment (up to 31.6 weeks gestation) minus first postpartum visit (2-8.6 weeks after delivery) to determine a change. Disruptions caused by COVID-19 created many challenges in longitudinal data collection.
Participants will be asked during the second trimester, third trimester, two months postpartum and six months postpartum (up to 50 weeks) to self-report electronic cigarette (e-cig) usage per day. Data will be presented as the change in e-cig usage per day compared between groups.
Outcome measures
| Measure |
Tobacco Intervention
n=4 Participants
Participants in this group will be randomized to the Behavioral and Enhanced Perinatal Intervention for Cessation (B-EPIC) intervention.
Behavioral and Enhanced Perinatal Intervention for Cessation (B-EPIC): Women enrolled in the intervention group will receive TAU plus B-EPIC, which includes four core components: 1) Individualized tobacco treatment plus supplemental counseling, 2) Biomarker validation and feedback, 3) Change in maternal thought process and adoption of healthy behavior (e.g. exercise, based on PI framework), and 4) Pharmacotherapy as needed (see Table 3 for a summary of the study design). The initial assessment for this intervention takes 60 minutes, with follow-up sessions typically lasting 15-20 minutes. All sessions occur prior to or after pre-scheduled perinatal appointments. The intervention will be led by a certified tobacco treatment specialist (CTTS).
|
Treatment As Usual
n=6 Participants
Participants in this group will be randomized to tobacco treatment as usual.
Treatment As Usual: Women enrolled in the control group are informed of the risks of tobacco use and benefits of quitting using the ACOG 5'A's approach by their healthcare provider. This standard takes approximately 5-15 minutes, and is offered at each prenatal and postpartum appointment. The five steps of the ACOG recommendation are: 1.) Ask about tobacco use, 2.) Advise to quit, 3.) Assess willingness to make a quit attempt, 4.) Assist in quit attempt, and 5.) Arrange follow-up. The provider may also talk to the participant about nicotine replacement therapy.
|
|---|---|---|
|
Change in Electronic Cigarette Usage Per Day
|
1 e-cig use times per day
Interval 0.0 to 18.0
|
-6 e-cig use times per day
Interval -20.0 to 4.0
|
PRIMARY outcome
Timeframe: up to 50 weeks (enrollment (up to 31.6 weeks gestation) minus postpartum visit (2-8.6 weeks after delivery))Population: Overall number of participants analyzed in each Group is based on the number of participants with Fagerstrom Test for Cigarette Dependence data available at study time points enrollment (up to 31.6 weeks gestation) minus postpartum visit (2-8.6 weeks after delivery) to determine a change. Disruptions caused by COVID-19 created many challenges in longitudinal data collection.
Participants will complete the Fagerstrom Test for Cigarette Dependence during the second trimester, third trimester, two months postpartum and six months postpartum (up to 50 weeks). The survey instrument asks seven questions related to cigarette dependency. For scoring, yes/no questions are scored from 0 to 1, and multiple choice questions from 0 to 3. Items are then summed to yield a total score of 0-10. The higher the total score, the more intense the patient's nicotine dependence. Any score greater than 8 is considered high dependency, a score of 5-7 is considered moderately dependent, 3-4 is low to moderate dependence and 1-2 is low dependence. Data will be presented as the change in cigarette dependency over time compared between groups.
Outcome measures
| Measure |
Tobacco Intervention
n=26 Participants
Participants in this group will be randomized to the Behavioral and Enhanced Perinatal Intervention for Cessation (B-EPIC) intervention.
Behavioral and Enhanced Perinatal Intervention for Cessation (B-EPIC): Women enrolled in the intervention group will receive TAU plus B-EPIC, which includes four core components: 1) Individualized tobacco treatment plus supplemental counseling, 2) Biomarker validation and feedback, 3) Change in maternal thought process and adoption of healthy behavior (e.g. exercise, based on PI framework), and 4) Pharmacotherapy as needed (see Table 3 for a summary of the study design). The initial assessment for this intervention takes 60 minutes, with follow-up sessions typically lasting 15-20 minutes. All sessions occur prior to or after pre-scheduled perinatal appointments. The intervention will be led by a certified tobacco treatment specialist (CTTS).
|
Treatment As Usual
n=24 Participants
Participants in this group will be randomized to tobacco treatment as usual.
Treatment As Usual: Women enrolled in the control group are informed of the risks of tobacco use and benefits of quitting using the ACOG 5'A's approach by their healthcare provider. This standard takes approximately 5-15 minutes, and is offered at each prenatal and postpartum appointment. The five steps of the ACOG recommendation are: 1.) Ask about tobacco use, 2.) Advise to quit, 3.) Assess willingness to make a quit attempt, 4.) Assist in quit attempt, and 5.) Arrange follow-up. The provider may also talk to the participant about nicotine replacement therapy.
|
|---|---|---|
|
Change in Cigarette Dependence
|
2.04 Score on a scale
Standard Deviation 3.14
|
1.42 Score on a scale
Standard Deviation 2.9
|
PRIMARY outcome
Timeframe: up to 50 weeks (enrollment (up to 31.6 weeks gestation) minus first postpartum visit (2-8.6 weeks after delivery))Population: Overall number of participants analyzed in each Group is based on the number of participants with Penn State Electronic Cigarette Dependence Index (PSECDI) data available at study time points enrollment (up to 31.6 weeks gestation) minus first postpartum visit (2-8.6 weeks after delivery) to determine a change. Disruptions caused by COVID-19 created many challenges in longitudinal data collection.
Participants will complete the Penn State Electronic Cigarette Dependence Index (PSECDI) during the second trimester, third trimester, two months postpartum and six months postpartum (up to 50 weeks). The survey instrument asks ten questions and responses are scored on a scale from zero to 20. Summed scores correlate to a dependence category; 0-3 is not dependent, 4-8 is low dependence, 9-12 is medium dependence, and above 12 is high dependence. Data will be presented as the change in electronic cigarette dependency over time compared between groups.
Outcome measures
| Measure |
Tobacco Intervention
n=1 Participants
Participants in this group will be randomized to the Behavioral and Enhanced Perinatal Intervention for Cessation (B-EPIC) intervention.
Behavioral and Enhanced Perinatal Intervention for Cessation (B-EPIC): Women enrolled in the intervention group will receive TAU plus B-EPIC, which includes four core components: 1) Individualized tobacco treatment plus supplemental counseling, 2) Biomarker validation and feedback, 3) Change in maternal thought process and adoption of healthy behavior (e.g. exercise, based on PI framework), and 4) Pharmacotherapy as needed (see Table 3 for a summary of the study design). The initial assessment for this intervention takes 60 minutes, with follow-up sessions typically lasting 15-20 minutes. All sessions occur prior to or after pre-scheduled perinatal appointments. The intervention will be led by a certified tobacco treatment specialist (CTTS).
|
Treatment As Usual
n=2 Participants
Participants in this group will be randomized to tobacco treatment as usual.
Treatment As Usual: Women enrolled in the control group are informed of the risks of tobacco use and benefits of quitting using the ACOG 5'A's approach by their healthcare provider. This standard takes approximately 5-15 minutes, and is offered at each prenatal and postpartum appointment. The five steps of the ACOG recommendation are: 1.) Ask about tobacco use, 2.) Advise to quit, 3.) Assess willingness to make a quit attempt, 4.) Assist in quit attempt, and 5.) Arrange follow-up. The provider may also talk to the participant about nicotine replacement therapy.
|
|---|---|---|
|
Change in Electronic Cigarette Dependence
|
-5.0 scores on a scale
|
-1.5 scores on a scale
Standard Deviation 2.12
|
SECONDARY outcome
Timeframe: Up to 50 weeks (enrollment (up to 31.6 weeks gestation) minus first postpartum visit (2-8.6 weeks after delivery))Population: Overall number of participants analyzed in each Group is based on the number of participants with Edinburgh Postnatal Depression Scale (EPDS) data available at study time points enrollment (up to 31.6 weeks gestation) minus first postpartum visit (2-8.6 weeks after delivery) to determine a change. Disruptions caused by COVID-19 created many challenges in longitudinal data collection.
Participants will complete the Edinburgh Postnatal Depression Scale (EPDS) during the second trimester, third trimester, two months postpartum and six months postpartum (up to 50 weeks). The survey consisted of 10 multiple choice questions with scores for each question ranging from 0-3. Scores are then summed for a total score, ranging from 0-30. Questions 1, 2 \& 4 are scored 0-3 with the first answer to each question scored as 0 and the fourth answer scored as 3. Questions 3 \& 5-10 are reverse scored, with the first answer to each question scored as 3 and the fourth answer scored as 0. A score of 10 or greater is interpreted as "possible depression". A score of greater than 0 on item 10 indicates "suicidal thoughts". Data will be presented as the change in depression over time compared between groups.
Outcome measures
| Measure |
Tobacco Intervention
n=26 Participants
Participants in this group will be randomized to the Behavioral and Enhanced Perinatal Intervention for Cessation (B-EPIC) intervention.
Behavioral and Enhanced Perinatal Intervention for Cessation (B-EPIC): Women enrolled in the intervention group will receive TAU plus B-EPIC, which includes four core components: 1) Individualized tobacco treatment plus supplemental counseling, 2) Biomarker validation and feedback, 3) Change in maternal thought process and adoption of healthy behavior (e.g. exercise, based on PI framework), and 4) Pharmacotherapy as needed (see Table 3 for a summary of the study design). The initial assessment for this intervention takes 60 minutes, with follow-up sessions typically lasting 15-20 minutes. All sessions occur prior to or after pre-scheduled perinatal appointments. The intervention will be led by a certified tobacco treatment specialist (CTTS).
|
Treatment As Usual
n=26 Participants
Participants in this group will be randomized to tobacco treatment as usual.
Treatment As Usual: Women enrolled in the control group are informed of the risks of tobacco use and benefits of quitting using the ACOG 5'A's approach by their healthcare provider. This standard takes approximately 5-15 minutes, and is offered at each prenatal and postpartum appointment. The five steps of the ACOG recommendation are: 1.) Ask about tobacco use, 2.) Advise to quit, 3.) Assess willingness to make a quit attempt, 4.) Assist in quit attempt, and 5.) Arrange follow-up. The provider may also talk to the participant about nicotine replacement therapy.
|
|---|---|---|
|
Change in Maternal Depression Over Time
|
2.42 score on a scale
Standard Deviation 3.86
|
2.58 score on a scale
Standard Deviation 5.64
|
SECONDARY outcome
Timeframe: Up to 50 weeks (enrollment (up to 31.6 weeks gestation) minus first postpartum visit (2-8.6 weeks after delivery))Population: Overall number of participants analyzed in each Group is based on the number of participants with Generalized Anxiety Disorder 7-item (GAD-7) data available at study time points enrollment (up to 31.6 weeks gestation) minus first postpartum visit (2-8.6 weeks after delivery) to determine a change. Disruptions caused by COVID-19 created many challenges in longitudinal data collection.
Participants will complete the Generalized Anxiety Disorder 7-item (GAD-7) scale during the second trimester, third trimester, two months postpartum and six months postpartum (up to 50 weeks). The survey consisted of 7 questions scored between zero and 21. A score of 5-9 indicates mild severity, 10-14 is moderate, and 15 and greater is considered severe. Data will be presented as the change in anxiety over time compared between groups.
Outcome measures
| Measure |
Tobacco Intervention
n=26 Participants
Participants in this group will be randomized to the Behavioral and Enhanced Perinatal Intervention for Cessation (B-EPIC) intervention.
Behavioral and Enhanced Perinatal Intervention for Cessation (B-EPIC): Women enrolled in the intervention group will receive TAU plus B-EPIC, which includes four core components: 1) Individualized tobacco treatment plus supplemental counseling, 2) Biomarker validation and feedback, 3) Change in maternal thought process and adoption of healthy behavior (e.g. exercise, based on PI framework), and 4) Pharmacotherapy as needed (see Table 3 for a summary of the study design). The initial assessment for this intervention takes 60 minutes, with follow-up sessions typically lasting 15-20 minutes. All sessions occur prior to or after pre-scheduled perinatal appointments. The intervention will be led by a certified tobacco treatment specialist (CTTS).
|
Treatment As Usual
n=25 Participants
Participants in this group will be randomized to tobacco treatment as usual.
Treatment As Usual: Women enrolled in the control group are informed of the risks of tobacco use and benefits of quitting using the ACOG 5'A's approach by their healthcare provider. This standard takes approximately 5-15 minutes, and is offered at each prenatal and postpartum appointment. The five steps of the ACOG recommendation are: 1.) Ask about tobacco use, 2.) Advise to quit, 3.) Assess willingness to make a quit attempt, 4.) Assist in quit attempt, and 5.) Arrange follow-up. The provider may also talk to the participant about nicotine replacement therapy.
|
|---|---|---|
|
Change in Maternal Anxiety Over Time
|
2.0 score on a scale
Standard Deviation 5.68
|
1.52 score on a scale
Standard Deviation 4.57
|
SECONDARY outcome
Timeframe: Up to 50 weeks (enrollment (up to 31.6 weeks gestation) minus first postpartum visit (2-8.6 weeks after delivery))Population: Overall number of participants analyzed in each Group is based on the number of participants with Perceived Stress Scale 4-item (PSS4) data available at study time points enrollment (up to 31.6 weeks gestation) minus first postpartum visit (2-8.6 weeks after delivery) to determine a change. Disruptions caused by COVID-19 created many challenges in longitudinal data collection.
Participants will complete the Perceived Stress Scale 4-item (PSS4) during the second trimester, third trimester, two months postpartum and six months postpartum (up to 50 weeks). The survey consisted of 4 questions scored between zero and 16. Higher scores are correlated with more stress. Data will be presented as the change in stress over time compared between groups.
Outcome measures
| Measure |
Tobacco Intervention
n=26 Participants
Participants in this group will be randomized to the Behavioral and Enhanced Perinatal Intervention for Cessation (B-EPIC) intervention.
Behavioral and Enhanced Perinatal Intervention for Cessation (B-EPIC): Women enrolled in the intervention group will receive TAU plus B-EPIC, which includes four core components: 1) Individualized tobacco treatment plus supplemental counseling, 2) Biomarker validation and feedback, 3) Change in maternal thought process and adoption of healthy behavior (e.g. exercise, based on PI framework), and 4) Pharmacotherapy as needed (see Table 3 for a summary of the study design). The initial assessment for this intervention takes 60 minutes, with follow-up sessions typically lasting 15-20 minutes. All sessions occur prior to or after pre-scheduled perinatal appointments. The intervention will be led by a certified tobacco treatment specialist (CTTS).
|
Treatment As Usual
n=24 Participants
Participants in this group will be randomized to tobacco treatment as usual.
Treatment As Usual: Women enrolled in the control group are informed of the risks of tobacco use and benefits of quitting using the ACOG 5'A's approach by their healthcare provider. This standard takes approximately 5-15 minutes, and is offered at each prenatal and postpartum appointment. The five steps of the ACOG recommendation are: 1.) Ask about tobacco use, 2.) Advise to quit, 3.) Assess willingness to make a quit attempt, 4.) Assist in quit attempt, and 5.) Arrange follow-up. The provider may also talk to the participant about nicotine replacement therapy.
|
|---|---|---|
|
Change in Maternal Perceived Stress Over Time
|
0.73 score on a scale
Standard Deviation 2.79
|
1.04 score on a scale
Standard Deviation 3.17
|
Adverse Events
Tobacco Intervention
Treatment As Usual
Serious adverse events
| Measure |
Tobacco Intervention
n=38 participants at risk
Participants in this group will be randomized to the Behavioral and Enhanced Perinatal Intervention for Cessation (B-EPIC) intervention.
Behavioral and Enhanced Perinatal Intervention for Cessation (B-EPIC): Women enrolled in the intervention group will receive TAU plus B-EPIC, which includes four core components: 1) Individualized tobacco treatment plus supplemental counseling, 2) Biomarker validation and feedback, 3) Change in maternal thought process and adoption of healthy behavior (e.g. exercise, based on PI framework), and 4) Pharmacotherapy as needed (see Table 3 for a summary of the study design). The initial assessment for this intervention takes 60 minutes, with follow-up sessions typically lasting 15-20 minutes. All sessions occur prior to or after pre-scheduled perinatal appointments. The intervention will be led by a certified tobacco treatment specialist (CTTS).
|
Treatment As Usual
n=38 participants at risk
Participants in this group will be randomized to tobacco treatment as usual.
Treatment As Usual: Women enrolled in the control group are informed of the risks of tobacco use and benefits of quitting using the ACOG 5'A's approach by their healthcare provider. This standard takes approximately 5-15 minutes, and is offered at each prenatal and postpartum appointment. The five steps of the ACOG recommendation are: 1.) Ask about tobacco use, 2.) Advise to quit, 3.) Assess willingness to make a quit attempt, 4.) Assist in quit attempt, and 5.) Arrange follow-up. The provider may also talk to the participant about nicotine replacement therapy.
|
|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
Initial or prolonged hospitalization
|
13.2%
5/38 • Enrollment (up to 31.6 weeks gestation) through second postpartum visit (20-28.6 weeks after delivery)
|
2.6%
1/38 • Enrollment (up to 31.6 weeks gestation) through second postpartum visit (20-28.6 weeks after delivery)
|
|
General disorders
Initial or prolonged hospitalization
|
10.5%
4/38 • Enrollment (up to 31.6 weeks gestation) through second postpartum visit (20-28.6 weeks after delivery)
|
5.3%
2/38 • Enrollment (up to 31.6 weeks gestation) through second postpartum visit (20-28.6 weeks after delivery)
|
Other adverse events
| Measure |
Tobacco Intervention
n=38 participants at risk
Participants in this group will be randomized to the Behavioral and Enhanced Perinatal Intervention for Cessation (B-EPIC) intervention.
Behavioral and Enhanced Perinatal Intervention for Cessation (B-EPIC): Women enrolled in the intervention group will receive TAU plus B-EPIC, which includes four core components: 1) Individualized tobacco treatment plus supplemental counseling, 2) Biomarker validation and feedback, 3) Change in maternal thought process and adoption of healthy behavior (e.g. exercise, based on PI framework), and 4) Pharmacotherapy as needed (see Table 3 for a summary of the study design). The initial assessment for this intervention takes 60 minutes, with follow-up sessions typically lasting 15-20 minutes. All sessions occur prior to or after pre-scheduled perinatal appointments. The intervention will be led by a certified tobacco treatment specialist (CTTS).
|
Treatment As Usual
n=38 participants at risk
Participants in this group will be randomized to tobacco treatment as usual.
Treatment As Usual: Women enrolled in the control group are informed of the risks of tobacco use and benefits of quitting using the ACOG 5'A's approach by their healthcare provider. This standard takes approximately 5-15 minutes, and is offered at each prenatal and postpartum appointment. The five steps of the ACOG recommendation are: 1.) Ask about tobacco use, 2.) Advise to quit, 3.) Assess willingness to make a quit attempt, 4.) Assist in quit attempt, and 5.) Arrange follow-up. The provider may also talk to the participant about nicotine replacement therapy.
|
|---|---|---|
|
Social circumstances
Incarceration
|
10.5%
4/38 • Enrollment (up to 31.6 weeks gestation) through second postpartum visit (20-28.6 weeks after delivery)
|
2.6%
1/38 • Enrollment (up to 31.6 weeks gestation) through second postpartum visit (20-28.6 weeks after delivery)
|
|
General disorders
Positive response to depression evaluation
|
10.5%
4/38 • Enrollment (up to 31.6 weeks gestation) through second postpartum visit (20-28.6 weeks after delivery)
|
5.3%
2/38 • Enrollment (up to 31.6 weeks gestation) through second postpartum visit (20-28.6 weeks after delivery)
|
|
General disorders
Treatment for dehydration
|
5.3%
2/38 • Enrollment (up to 31.6 weeks gestation) through second postpartum visit (20-28.6 weeks after delivery)
|
0.00%
0/38 • Enrollment (up to 31.6 weeks gestation) through second postpartum visit (20-28.6 weeks after delivery)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place