Trial Outcomes & Findings for Financial Incentives for Smoking Cessation Among Disadvantaged Pregnant Women (NCT NCT02210832)
NCT ID: NCT02210832
Last Updated: 2023-08-24
Results Overview
Abstinence was defined as woman reports that she has not smoked, not even a puff, in the past 7 days and self-report is biochemically verified via urine cotinine testing
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
257 participants
Primary outcome timeframe
collected once per women at approximately 28-weeks gestation in each of the two smoking arms
Results posted on
2023-08-24
Participant Flow
Participant milestones
| Measure |
Best Practices for Pregnant Smokers
Five As plus referral to pregnancy-specific tobacco quit line
Best practices
|
Best Practices Plus Financial Incentives
Best practices plus providing financial incentives contingent on biochemically verified abstinence. Incentives are in the form of vouchers exchangeable for retail items and available through 12-weeks postpartum.
Best practices
financial incentives: financial incentives provided contingent on biochemically confirmed smoking abstinence
|
Never-smoker Comparison Condition
We will follow a group of never-smoker pregnant women matched to smokers on key sociodemographic and obstetrical characteristics for purposes of comparisons in birth/health outcomes at delivery and through 1 year postpartum
|
|---|---|---|---|
|
Overall Study
STARTED
|
91
|
85
|
81
|
|
Overall Study
COMPLETED
|
62
|
49
|
63
|
|
Overall Study
NOT COMPLETED
|
29
|
36
|
18
|
Reasons for withdrawal
| Measure |
Best Practices for Pregnant Smokers
Five As plus referral to pregnancy-specific tobacco quit line
Best practices
|
Best Practices Plus Financial Incentives
Best practices plus providing financial incentives contingent on biochemically verified abstinence. Incentives are in the form of vouchers exchangeable for retail items and available through 12-weeks postpartum.
Best practices
financial incentives: financial incentives provided contingent on biochemically confirmed smoking abstinence
|
Never-smoker Comparison Condition
We will follow a group of never-smoker pregnant women matched to smokers on key sociodemographic and obstetrical characteristics for purposes of comparisons in birth/health outcomes at delivery and through 1 year postpartum
|
|---|---|---|---|
|
Overall Study
Pregnancy termination .
|
3
|
4
|
1
|
|
Overall Study
Lost to Follow-up
|
26
|
32
|
17
|
Baseline Characteristics
Financial Incentives for Smoking Cessation Among Disadvantaged Pregnant Women
Baseline characteristics by cohort
| Measure |
Best Practices for Pregnant Smokers
n=88 Participants
Five As plus referral to pregnancy-specific tobacco quit line
Best practices
|
Best Practices Plus Financial Incentives
n=81 Participants
Best practices plus providing financial incentives contingent on biochemically verified abstinence. Incentives are in the form of vouchers exchangeable for retail items and available through 12-weeks postpartum.
Best practices
financial incentives: financial incentives provided contingent on biochemically confirmed smoking abstinence
|
Never-smoker Comparison Condition
n=80 Participants
We will follow a group of never-smoker pregnant women matched to smokers on key sociodemographic and obstetrical characteristics for purposes of comparisons in birth/health outcomes at delivery and through 1 year postpartum
|
Total
n=249 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
26.6 years
STANDARD_DEVIATION 5.5 • n=5 Participants
|
25.4 years
STANDARD_DEVIATION 5.0 • n=7 Participants
|
25.6 years
STANDARD_DEVIATION 5.0 • n=5 Participants
|
25.87 years
STANDARD_DEVIATION 5.17 • n=4 Participants
|
|
Sex: Female, Male
Female
|
88 Participants
n=5 Participants
|
81 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
249 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
82 Participants
n=5 Participants
|
74 Participants
n=7 Participants
|
72 Participants
n=5 Participants
|
228 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
88 participants
n=5 Participants
|
81 participants
n=7 Participants
|
80 participants
n=5 Participants
|
249 participants
n=4 Participants
|
|
Cigarettes smoked per day pre-pregnancy
|
18.27 cigarettes/day
STANDARD_DEVIATION 9.42 • n=5 Participants
|
19.25 cigarettes/day
STANDARD_DEVIATION 9.87 • n=7 Participants
|
0 cigarettes/day
STANDARD_DEVIATION 0 • n=5 Participants
|
12.51 cigarettes/day
STANDARD_DEVIATION 6.43 • n=4 Participants
|
|
Cigarettes smoked per day at 1st antepartum visit
|
9.92 cigarettes/day
STANDARD_DEVIATION 6.18 • n=5 Participants
|
8.99 cigarettes/day
STANDARD_DEVIATION 5.21 • n=7 Participants
|
0 cigarettes/day
STANDARD_DEVIATION 0 • n=5 Participants
|
6.30 cigarettes/day
STANDARD_DEVIATION 3.80 • n=4 Participants
|
|
Age started smoking (yrs)
|
15.47 years
STANDARD_DEVIATION 2.96 • n=5 Participants
|
15.10 years
STANDARD_DEVIATION 2.92 • n=7 Participants
|
0 years
STANDARD_DEVIATION 0 • n=5 Participants
|
10.19 years
STANDARD_DEVIATION 1.96 • n=4 Participants
|
|
% living with other smokers
|
68 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
150 Participants
n=4 Participants
|
|
% with no smoking allowed in home
|
62 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
73 Participants
n=5 Participants
|
190 Participants
n=4 Participants
|
|
% with none or few family who smoke
|
23 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
105 Participants
n=4 Participants
|
|
% attempted to quit prepregnancy
|
64 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
121 Participants
n=4 Participants
|
|
# quit attempts during pregnancy
|
0.73 attempts
STANDARD_DEVIATION 2.35 • n=5 Participants
|
0.57 attempts
STANDARD_DEVIATION 0.97 • n=7 Participants
|
0 attempts
STANDARD_DEVIATION 0 • n=5 Participants
|
0.43 attempts
STANDARD_DEVIATION 1.11 • n=4 Participants
|
|
Minnesota Nicotine Withdrawal Scale total score; scale: 0 (none) to 4 (severe);average item scores
|
1.60 scores on a scale
STANDARD_DEVIATION 0.75 • n=5 Participants
|
1.37 scores on a scale
STANDARD_DEVIATION 0.76 • n=7 Participants
|
0 scores on a scale
STANDARD_DEVIATION 0 • n=5 Participants
|
0.99 scores on a scale
STANDARD_DEVIATION 0.50 • n=4 Participants
|
|
Fagerstrom Test for Nicotine Dependence
|
4.33 0-10 scale
STANDARD_DEVIATION 2.30 • n=5 Participants
|
3.98 0-10 scale
STANDARD_DEVIATION 2.07 • n=7 Participants
|
0 0-10 scale
STANDARD_DEVIATION 0 • n=5 Participants
|
2.77 0-10 scale
STANDARD_DEVIATION 1.46 • n=4 Participants
|
|
% endorsing that smoking will greatly harm baby
|
70 Participants
n=5 Participants
|
69 Participants
n=7 Participants
|
79 Participants
n=5 Participants
|
218 Participants
n=4 Participants
|
|
Stress rating scale for past week from 0 (none) to 10 (extreme)
|
6.3 Scores on a scale
STANDARD_DEVIATION 2.2 • n=5 Participants
|
5.0 Scores on a scale
STANDARD_DEVIATION 2.5 • n=7 Participants
|
3.3 Scores on a scale
STANDARD_DEVIATION 2.1 • n=5 Participants
|
4.9 Scores on a scale
STANDARD_DEVIATION 2.3 • n=4 Participants
|
|
Beck Depression Inventory total score
|
12.8 units on a 0-63 scale
STANDARD_DEVIATION 8.6 • n=5 Participants
|
10.0 units on a 0-63 scale
STANDARD_DEVIATION 7.4 • n=7 Participants
|
5.8 units on a 0-63 scale
STANDARD_DEVIATION 5.2 • n=5 Participants
|
9.5 units on a 0-63 scale
STANDARD_DEVIATION 7.1 • n=4 Participants
|
PRIMARY outcome
Timeframe: collected once per women at approximately 28-weeks gestation in each of the two smoking armsPopulation: Comparison of women in two smoking-cessation arms
Abstinence was defined as woman reports that she has not smoked, not even a puff, in the past 7 days and self-report is biochemically verified via urine cotinine testing
Outcome measures
| Measure |
Best Practices for Pregnant Smokers
n=88 Participants
Five As plus referral to pregnancy-specific tobacco quit line
Best practices
|
Best Practices Plus Financial Incentives
n=81 Participants
Best practices plus providing financial incentives contingent on biochemically verified abstinence. Incentives are in the form of vouchers exchangeable for retail items and available through 12-weeks postpartum.
Best practices
financial incentives: financial incentives provided contingent on biochemically confirmed smoking abstinence
|
Never-smoker Comparison Condition
We will follow a group of never-smoker pregnant women matched to smokers on key sociodemographic and obstetrical characteristics for purposes of comparisons in birth/health outcomes at delivery and through 1 year postpartum
|
|---|---|---|---|
|
7-day Point Prevalence Abstinence Levels at Final Antepartum Assessment
|
8 Participants
|
31 Participants
|
—
|
SECONDARY outcome
Timeframe: Repeated assessments completed at 2-, 4-, 8-, 12-, 24-, and 48-weeks postpartumPopulation: Hypothesized that women assigned to Best practices plus financial incentives would achieve greater smoking abstinence than women assigned to Best practices only.
Compare two treatment arms on 7-day point-prevalence abstinence assessed at 2-, 4-, 8-, 12-, 24- and 48-weeks postpartum. Abstinence was defined as self-report of no smoking in past 7 days, not even a puff, with biochemical verification of self-report using urine cotinine testing
Outcome measures
| Measure |
Best Practices for Pregnant Smokers
n=88 Participants
Five As plus referral to pregnancy-specific tobacco quit line
Best practices
|
Best Practices Plus Financial Incentives
n=81 Participants
Best practices plus providing financial incentives contingent on biochemically verified abstinence. Incentives are in the form of vouchers exchangeable for retail items and available through 12-weeks postpartum.
Best practices
financial incentives: financial incentives provided contingent on biochemically confirmed smoking abstinence
|
Never-smoker Comparison Condition
We will follow a group of never-smoker pregnant women matched to smokers on key sociodemographic and obstetrical characteristics for purposes of comparisons in birth/health outcomes at delivery and through 1 year postpartum
|
|---|---|---|---|
|
7-day Point Prevalence Abstinence Postpartum
24 weeks postpartum
|
11 Participants
|
14 Participants
|
—
|
|
7-day Point Prevalence Abstinence Postpartum
2 weeks postpartum
|
17 Participants
|
31 Participants
|
—
|
|
7-day Point Prevalence Abstinence Postpartum
4 weeks postpartum
|
14 Participants
|
30 Participants
|
—
|
|
7-day Point Prevalence Abstinence Postpartum
8 weeks postpartum
|
12 Participants
|
25 Participants
|
—
|
|
7-day Point Prevalence Abstinence Postpartum
12 weeks postpartum
|
10 Participants
|
21 Participants
|
—
|
|
7-day Point Prevalence Abstinence Postpartum
48 weeks postpartum
|
10 Participants
|
13 Participants
|
—
|
SECONDARY outcome
Timeframe: Repeated assessments completed at 2-, 4-, 8-, 12-, 24-, and 48-weeks postpartumPopulation: Breastfeeding data were not obtained on all women. The number of women with at least one assessment with breastfeeding data in each group is: Best practices = 79, Best practices plus financial incentives = 69, Never-Smokers = 78
Compare the three trial arms on overall percentage of women continuing to breastfeed at repeated postpartum assessments
Outcome measures
| Measure |
Best Practices for Pregnant Smokers
n=79 Participants
Five As plus referral to pregnancy-specific tobacco quit line
Best practices
|
Best Practices Plus Financial Incentives
n=69 Participants
Best practices plus providing financial incentives contingent on biochemically verified abstinence. Incentives are in the form of vouchers exchangeable for retail items and available through 12-weeks postpartum.
Best practices
financial incentives: financial incentives provided contingent on biochemically confirmed smoking abstinence
|
Never-smoker Comparison Condition
n=78 Participants
We will follow a group of never-smoker pregnant women matched to smokers on key sociodemographic and obstetrical characteristics for purposes of comparisons in birth/health outcomes at delivery and through 1 year postpartum
|
|---|---|---|---|
|
Breastfeeding in the Three Trial Arms
2-weeks postpartum
|
49 Participants
|
50 Participants
|
59 Participants
|
|
Breastfeeding in the Three Trial Arms
4-weeks postpartum
|
40 Participants
|
40 Participants
|
56 Participants
|
|
Breastfeeding in the Three Trial Arms
8-weeks postpartum
|
34 Participants
|
34 Participants
|
48 Participants
|
|
Breastfeeding in the Three Trial Arms
12-weeks postpartum
|
28 Participants
|
28 Participants
|
43 Participants
|
|
Breastfeeding in the Three Trial Arms
24-weeks postpartum
|
21 Participants
|
21 Participants
|
36 Participants
|
|
Breastfeeding in the Three Trial Arms
48-weeks postpartum
|
9 Participants
|
9 Participants
|
23 Participants
|
SECONDARY outcome
Timeframe: Repeated assessments completed at 2-, 4-, 8-, 12-, 24-, and 48-weeks postpartumPopulation: Comparing women in each trial condition who reported breastfeeding and were biochemically confirmed abstinent from smoking at each postpartum assessment. Breastfeeding data were not obtained on all women. The number of women with at least one assessment with breastfeeding data in each group is: Best practices = 79, Best practices plus financial incentives = 69, Never-Smokers = 78
We compared the three trial arms on the percent of women who reported breastfeeding and were biochemically confirmed to be abstinent from smoking at each postpartum assessment.
Outcome measures
| Measure |
Best Practices for Pregnant Smokers
n=79 Participants
Five As plus referral to pregnancy-specific tobacco quit line
Best practices
|
Best Practices Plus Financial Incentives
n=69 Participants
Best practices plus providing financial incentives contingent on biochemically verified abstinence. Incentives are in the form of vouchers exchangeable for retail items and available through 12-weeks postpartum.
Best practices
financial incentives: financial incentives provided contingent on biochemically confirmed smoking abstinence
|
Never-smoker Comparison Condition
n=78 Participants
We will follow a group of never-smoker pregnant women matched to smokers on key sociodemographic and obstetrical characteristics for purposes of comparisons in birth/health outcomes at delivery and through 1 year postpartum
|
|---|---|---|---|
|
Breastfeeding While Abstinent From Smoking
2-weeks postpartum
|
15 Participants
|
29 Participants
|
59 Participants
|
|
Breastfeeding While Abstinent From Smoking
4-weeks postpartum
|
11 Participants
|
24 Participants
|
56 Participants
|
|
Breastfeeding While Abstinent From Smoking
8-weeks postpartum
|
9 Participants
|
19 Participants
|
48 Participants
|
|
Breastfeeding While Abstinent From Smoking
12-weeks postpartum
|
7 Participants
|
15 Participants
|
43 Participants
|
|
Breastfeeding While Abstinent From Smoking
24-weeks postpartum
|
7 Participants
|
9 Participants
|
36 Participants
|
|
Breastfeeding While Abstinent From Smoking
48-weeks postpartum
|
3 Participants
|
5 Participants
|
23 Participants
|
SECONDARY outcome
Timeframe: Outcomes reported for 8 assessments (early pregnancy, late pregnancy, 2, 4, 8, 12, 24, 28 weeks postpartum.Population: Comparing between women assigned to the two smoking-cessation trial conditions.
The craving item is on a 0 (none) to 4 (severe) scale. We report mean (SEM) scores.
Outcome measures
| Measure |
Best Practices for Pregnant Smokers
n=88 Participants
Five As plus referral to pregnancy-specific tobacco quit line
Best practices
|
Best Practices Plus Financial Incentives
n=81 Participants
Best practices plus providing financial incentives contingent on biochemically verified abstinence. Incentives are in the form of vouchers exchangeable for retail items and available through 12-weeks postpartum.
Best practices
financial incentives: financial incentives provided contingent on biochemically confirmed smoking abstinence
|
Never-smoker Comparison Condition
We will follow a group of never-smoker pregnant women matched to smokers on key sociodemographic and obstetrical characteristics for purposes of comparisons in birth/health outcomes at delivery and through 1 year postpartum
|
|---|---|---|---|
|
Craving Item From the Minnesota Nicotine Withdrawal Scale (MNWS).
early antepartum
|
2.73 scores on a scale
Standard Error 0.14
|
1.75 scores on a scale
Standard Error 0.15
|
—
|
|
Craving Item From the Minnesota Nicotine Withdrawal Scale (MNWS).
late antepartum
|
2.30 scores on a scale
Standard Error 0.14
|
1.52 scores on a scale
Standard Error 0.15
|
—
|
|
Craving Item From the Minnesota Nicotine Withdrawal Scale (MNWS).
2 weeks postpartum
|
2.14 scores on a scale
Standard Error 0.15
|
1.39 scores on a scale
Standard Error 0.16
|
—
|
|
Craving Item From the Minnesota Nicotine Withdrawal Scale (MNWS).
4 weeks postpartum
|
2.17 scores on a scale
Standard Error 0.15
|
1.55 scores on a scale
Standard Error 0.16
|
—
|
|
Craving Item From the Minnesota Nicotine Withdrawal Scale (MNWS).
8 weeks postpartum
|
2.27 scores on a scale
Standard Error 0.15
|
1.75 scores on a scale
Standard Error 0.16
|
—
|
|
Craving Item From the Minnesota Nicotine Withdrawal Scale (MNWS).
12 weeks postpartum
|
2.33 scores on a scale
Standard Error 0.14
|
1.72 scores on a scale
Standard Error 0.16
|
—
|
|
Craving Item From the Minnesota Nicotine Withdrawal Scale (MNWS).
24 weeks postpartum
|
1.97 scores on a scale
Standard Error 0.15
|
1.97 scores on a scale
Standard Error 0.16
|
—
|
|
Craving Item From the Minnesota Nicotine Withdrawal Scale (MNWS).
48 weeks postpartum
|
2.10 scores on a scale
Standard Error 0.16
|
1.99 scores on a scale
Standard Error 0.17
|
—
|
SECONDARY outcome
Timeframe: Outcomes reported for 8 assessments (early pregnancy, late pregnancy, 2, 4, 8, 12, 24, 28 weeks postpartum.Population: Comparing women assigned to the two smoking-cessation trial conditions.
Reporting mean total scores and SEM from the Minnesota Nicotine Withdrawal Scale (MNWS). Total score is an average of 7 items, with each item on a 0 (none) to 4 (severe) scale.
Outcome measures
| Measure |
Best Practices for Pregnant Smokers
n=88 Participants
Five As plus referral to pregnancy-specific tobacco quit line
Best practices
|
Best Practices Plus Financial Incentives
n=81 Participants
Best practices plus providing financial incentives contingent on biochemically verified abstinence. Incentives are in the form of vouchers exchangeable for retail items and available through 12-weeks postpartum.
Best practices
financial incentives: financial incentives provided contingent on biochemically confirmed smoking abstinence
|
Never-smoker Comparison Condition
We will follow a group of never-smoker pregnant women matched to smokers on key sociodemographic and obstetrical characteristics for purposes of comparisons in birth/health outcomes at delivery and through 1 year postpartum
|
|---|---|---|---|
|
Nicotine Withdrawal Total Scores for the Two Smoking-cessation Trial Conditions.
Early antepartum
|
1.47 scores on a scale
Standard Error 0.08
|
1.02 scores on a scale
Standard Error 0.08
|
—
|
|
Nicotine Withdrawal Total Scores for the Two Smoking-cessation Trial Conditions.
Late antepartum
|
1.38 scores on a scale
Standard Error 0.08
|
0.93 scores on a scale
Standard Error 0.08
|
—
|
|
Nicotine Withdrawal Total Scores for the Two Smoking-cessation Trial Conditions.
2-weeks postpartum
|
0.80 scores on a scale
Standard Error 0.08
|
0.70 scores on a scale
Standard Error 0.09
|
—
|
|
Nicotine Withdrawal Total Scores for the Two Smoking-cessation Trial Conditions.
4-weeks postpartum
|
0.80 scores on a scale
Standard Error 0.08
|
0.68 scores on a scale
Standard Error 0.09
|
—
|
|
Nicotine Withdrawal Total Scores for the Two Smoking-cessation Trial Conditions.
8-weeks postpartum
|
0.92 scores on a scale
Standard Error 0.08
|
0.68 scores on a scale
Standard Error 0.08
|
—
|
|
Nicotine Withdrawal Total Scores for the Two Smoking-cessation Trial Conditions.
12-weeks postpartum
|
0.86 scores on a scale
Standard Error 0.08
|
0.59 scores on a scale
Standard Error 0.08
|
—
|
|
Nicotine Withdrawal Total Scores for the Two Smoking-cessation Trial Conditions.
24-weeks postpartum
|
0.81 scores on a scale
Standard Error 0.08
|
0.78 scores on a scale
Standard Error 0.09
|
—
|
|
Nicotine Withdrawal Total Scores for the Two Smoking-cessation Trial Conditions.
48-weeks postpartum
|
1.03 scores on a scale
Standard Error 0.8
|
0.84 scores on a scale
Standard Error 0.09
|
—
|
SECONDARY outcome
Timeframe: delivery, 24-week, and 50-week postpartum assessmentsPopulation: There was data available for one or more assessments for 79, 67, and 77 of infants born to mothers in the Best practices, Best practices plus financial incentives, and never-smoker conditions. We compared body mass index (BMI) percentile scores between infants from the three trial conditions at delivery, 24-weeks postpartum, and 48-weeks postpartum.
Infant growth (length \& weight) expressed a Body Mass Index (BMI) percentile score was assessed at delivery, 24- and 48-week postpartum assessments.
Outcome measures
| Measure |
Best Practices for Pregnant Smokers
n=79 Participants
Five As plus referral to pregnancy-specific tobacco quit line
Best practices
|
Best Practices Plus Financial Incentives
n=67 Participants
Best practices plus providing financial incentives contingent on biochemically verified abstinence. Incentives are in the form of vouchers exchangeable for retail items and available through 12-weeks postpartum.
Best practices
financial incentives: financial incentives provided contingent on biochemically confirmed smoking abstinence
|
Never-smoker Comparison Condition
n=77 Participants
We will follow a group of never-smoker pregnant women matched to smokers on key sociodemographic and obstetrical characteristics for purposes of comparisons in birth/health outcomes at delivery and through 1 year postpartum
|
|---|---|---|---|
|
Infant Growth in First Year of Life
Birth
|
31.39 BMI Percentile
Standard Error 3.35
|
34.92 BMI Percentile
Standard Error 3.51
|
40.56 BMI Percentile
Standard Error 3.20
|
|
Infant Growth in First Year of Life
24-weeks postpartum
|
56.19 BMI Percentile
Standard Error 3.36
|
59.14 BMI Percentile
Standard Error 3.71
|
46.15 BMI Percentile
Standard Error 3.39
|
|
Infant Growth in First Year of Life
48-weeks postpartum
|
65.97 BMI Percentile
Standard Error 3.73
|
65.69 BMI Percentile
Standard Error 4.06
|
66.62 BMI Percentile
Standard Error 3.47
|
SECONDARY outcome
Timeframe: deliveryPopulation: Comparison of three trial conditions on SGA deliveries
Birth outcomes were compared between the three study arms. Small for gestational age was defined as \<10th percentile using INTERGROWTH-21st \[2021\] https://intergrowth21.tghn.org/about/about-us/.
Outcome measures
| Measure |
Best Practices for Pregnant Smokers
n=88 Participants
Five As plus referral to pregnancy-specific tobacco quit line
Best practices
|
Best Practices Plus Financial Incentives
n=76 Participants
Best practices plus providing financial incentives contingent on biochemically verified abstinence. Incentives are in the form of vouchers exchangeable for retail items and available through 12-weeks postpartum.
Best practices
financial incentives: financial incentives provided contingent on biochemically confirmed smoking abstinence
|
Never-smoker Comparison Condition
n=79 Participants
We will follow a group of never-smoker pregnant women matched to smokers on key sociodemographic and obstetrical characteristics for purposes of comparisons in birth/health outcomes at delivery and through 1 year postpartum
|
|---|---|---|---|
|
Birth Outcomes (% Small for Gestational Age Deliveries)
Small for Gestational Age
|
16 Participants
|
8 Participants
|
2 Participants
|
|
Birth Outcomes (% Small for Gestational Age Deliveries)
Normal size for gestational age
|
72 Participants
|
68 Participants
|
77 Participants
|
SECONDARY outcome
Timeframe: at deliveryCompared the three trials conditions on preterm deliveries.
Outcome measures
| Measure |
Best Practices for Pregnant Smokers
n=88 Participants
Five As plus referral to pregnancy-specific tobacco quit line
Best practices
|
Best Practices Plus Financial Incentives
n=76 Participants
Best practices plus providing financial incentives contingent on biochemically verified abstinence. Incentives are in the form of vouchers exchangeable for retail items and available through 12-weeks postpartum.
Best practices
financial incentives: financial incentives provided contingent on biochemically confirmed smoking abstinence
|
Never-smoker Comparison Condition
n=79 Participants
We will follow a group of never-smoker pregnant women matched to smokers on key sociodemographic and obstetrical characteristics for purposes of comparisons in birth/health outcomes at delivery and through 1 year postpartum
|
|---|---|---|---|
|
Birth Outcomes (Percent Preterm [<37 Weeks] Deliveries)
preterm
|
6 Participants
|
10 Participants
|
6 Participants
|
|
Birth Outcomes (Percent Preterm [<37 Weeks] Deliveries)
>/= 37 weeks
|
82 Participants
|
66 Participants
|
73 Participants
|
SECONDARY outcome
Timeframe: at deliveryPopulation: Compared three trial conditions on NICU admissions.
Compared three trial conditions on percent of NICU admissions
Outcome measures
| Measure |
Best Practices for Pregnant Smokers
n=88 Participants
Five As plus referral to pregnancy-specific tobacco quit line
Best practices
|
Best Practices Plus Financial Incentives
n=76 Participants
Best practices plus providing financial incentives contingent on biochemically verified abstinence. Incentives are in the form of vouchers exchangeable for retail items and available through 12-weeks postpartum.
Best practices
financial incentives: financial incentives provided contingent on biochemically confirmed smoking abstinence
|
Never-smoker Comparison Condition
n=79 Participants
We will follow a group of never-smoker pregnant women matched to smokers on key sociodemographic and obstetrical characteristics for purposes of comparisons in birth/health outcomes at delivery and through 1 year postpartum
|
|---|---|---|---|
|
Birth Outcomes (NICU Admissions)
NICU admitted
|
11 Participants
|
10 Participants
|
11 Participants
|
|
Birth Outcomes (NICU Admissions)
no NICU
|
77 Participants
|
66 Participants
|
68 Participants
|
SECONDARY outcome
Timeframe: 24- and 48-weeks postpartumPopulation: Overall number of participants analyzed represents the number of participants for whom we obtained data on this outcome at 24-weeks postpartum; at 48-weeks the overall number analyzed were 69, 56, and 72 in Best Practices, Best Practices plus financial incentives, and never-smokers, respectively.
The ASQ assesses infant development in five areas (communication \[Comm\], gross motor \[GM\], fine motor \[FM\], problem solving \[PrbSlv\], personal-social \[PerSoc\]); Each area includes six items, each with a possible value of 0, 5, 10, along with a cutoff to dichotomize infants into typical/normal vs. monitor/potential delay categories for an area. Scores in each area are compared to norms; scores with 1 standard deviation of the norm mean are categorized as typical/normal and those greater than one standard deviation below the norm mean are categorized as monitor/potential delay. We report the dichotomized outcomes for each of the six areas at the 24-week and 48-week assessments noting the number of infants in each treatment condition in the monitor/potential delay category.
Outcome measures
| Measure |
Best Practices for Pregnant Smokers
n=72 Participants
Five As plus referral to pregnancy-specific tobacco quit line
Best practices
|
Best Practices Plus Financial Incentives
n=58 Participants
Best practices plus providing financial incentives contingent on biochemically verified abstinence. Incentives are in the form of vouchers exchangeable for retail items and available through 12-weeks postpartum.
Best practices
financial incentives: financial incentives provided contingent on biochemically confirmed smoking abstinence
|
Never-smoker Comparison Condition
n=68 Participants
We will follow a group of never-smoker pregnant women matched to smokers on key sociodemographic and obstetrical characteristics for purposes of comparisons in birth/health outcomes at delivery and through 1 year postpartum
|
|---|---|---|---|
|
Ages & Stages Questionnaire (ASQ)
Comm at 24-weeks
|
1 Participants
|
2 Participants
|
3 Participants
|
|
Ages & Stages Questionnaire (ASQ)
Comm at 48-weeks
|
2 Participants
|
0 Participants
|
3 Participants
|
|
Ages & Stages Questionnaire (ASQ)
GM at 24-weeks
|
18 Participants
|
10 Participants
|
10 Participants
|
|
Ages & Stages Questionnaire (ASQ)
GM at 48-weeks
|
14 Participants
|
6 Participants
|
13 Participants
|
|
Ages & Stages Questionnaire (ASQ)
FM at 24-weeks
|
28 Participants
|
17 Participants
|
16 Participants
|
|
Ages & Stages Questionnaire (ASQ)
FM at 48-weeks
|
7 Participants
|
5 Participants
|
7 Participants
|
|
Ages & Stages Questionnaire (ASQ)
PrbSlv at 24-weeks
|
17 Participants
|
7 Participants
|
10 Participants
|
|
Ages & Stages Questionnaire (ASQ)
PrbSlv at 48-weeks
|
10 Participants
|
3 Participants
|
13 Participants
|
|
Ages & Stages Questionnaire (ASQ)
PerSoc at 24-weeks
|
15 Participants
|
9 Participants
|
13 Participants
|
|
Ages & Stages Questionnaire (ASQ)
PerSoc at 48-weeks
|
11 Participants
|
8 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: at deliveryPopulation: Birth outcomes were obtained from 88, 76, and 79 infants born to women in the best practices, best practices plus financial incentives, and never-smoker conditions.
Birth outcomes were obtained from the birth record. Gestational age was expressed in weeks.
Outcome measures
| Measure |
Best Practices for Pregnant Smokers
n=88 Participants
Five As plus referral to pregnancy-specific tobacco quit line
Best practices
|
Best Practices Plus Financial Incentives
n=76 Participants
Best practices plus providing financial incentives contingent on biochemically verified abstinence. Incentives are in the form of vouchers exchangeable for retail items and available through 12-weeks postpartum.
Best practices
financial incentives: financial incentives provided contingent on biochemically confirmed smoking abstinence
|
Never-smoker Comparison Condition
n=79 Participants
We will follow a group of never-smoker pregnant women matched to smokers on key sociodemographic and obstetrical characteristics for purposes of comparisons in birth/health outcomes at delivery and through 1 year postpartum
|
|---|---|---|---|
|
Birth Outcome: Gestational Age at Delivery
|
39.18 gestational age (weeks)
Standard Error 0.22
|
38.69 gestational age (weeks)
Standard Error 0.23
|
39.35 gestational age (weeks)
Standard Error 0.22
|
SECONDARY outcome
Timeframe: Trial entry through 24-weeks postpartum (approximately one year following smoking-cessation quit date).Population: All participants treated in best practices plus financial incentives and best practices trial conditions.
Cost per participant for BP+FI and BP interventions. These costs per participant are used in calculation of the Incremental Cost Effectiveness Ratio (ICER). This ICER measure is the added healthcare sector cost per participant for BP+FI compared to BP relative to estimated net health gain per participant (QALY). Maternal net health gains in QALYs from cessation difference between treatment conditions at 24 weeks postpartum were based on Stapleton \& West, 2012, Nicotine Tob Res; 14: 463-71.
Outcome measures
| Measure |
Best Practices for Pregnant Smokers
n=81 Participants
Five As plus referral to pregnancy-specific tobacco quit line
Best practices
|
Best Practices Plus Financial Incentives
n=88 Participants
Best practices plus providing financial incentives contingent on biochemically verified abstinence. Incentives are in the form of vouchers exchangeable for retail items and available through 12-weeks postpartum.
Best practices
financial incentives: financial incentives provided contingent on biochemically confirmed smoking abstinence
|
Never-smoker Comparison Condition
We will follow a group of never-smoker pregnant women matched to smokers on key sociodemographic and obstetrical characteristics for purposes of comparisons in birth/health outcomes at delivery and through 1 year postpartum
|
|---|---|---|---|
|
Cost Per Participant
|
23007.01 U.S. dollars
Standard Error 1284.83
|
22372.25 U.S. dollars
Standard Error 1594.23
|
—
|
SECONDARY outcome
Timeframe: 24 weeks postpartumPopulation: Analysis of results for this measure cannot be reported separately for each treatment arm. Thus, treatment conditions were combined because the outcome is the difference in quality of life years gained (QALYs) between conditions.
Smoking abstinence at the 24-week assessment was converted into quality of life years gained using standardized tables reported in Stapleton \& West, 2012, Nicotine Tob Res; 14: 463-71.
Outcome measures
| Measure |
Best Practices for Pregnant Smokers
n=169 Participants
Five As plus referral to pregnancy-specific tobacco quit line
Best practices
|
Best Practices Plus Financial Incentives
Best practices plus providing financial incentives contingent on biochemically verified abstinence. Incentives are in the form of vouchers exchangeable for retail items and available through 12-weeks postpartum.
Best practices
financial incentives: financial incentives provided contingent on biochemically confirmed smoking abstinence
|
Never-smoker Comparison Condition
We will follow a group of never-smoker pregnant women matched to smokers on key sociodemographic and obstetrical characteristics for purposes of comparisons in birth/health outcomes at delivery and through 1 year postpartum
|
|---|---|---|---|
|
Quality of Life Years Gained (QALYs)
|
0.0267 net years gained
Standard Deviation 0.0412
|
—
|
—
|
SECONDARY outcome
Timeframe: 24 weeks postpartumPopulation: Treatment conditions were combined because the ICER outcome is a measure of the economic benefit of the BP+FI intervention relative to the BP comparator.
A summary measure representing the economic value of an intervention (BP+FI) compared with an alternative (BP). The measure type used below is 'number' due to the fact that this measure is simply a ratio of mean dollars divided by mean years gained between the treatment conditions. Thus there was no alternative measure type that could be used or measure of dispersion available.
Outcome measures
| Measure |
Best Practices for Pregnant Smokers
n=169 Participants
Five As plus referral to pregnancy-specific tobacco quit line
Best practices
|
Best Practices Plus Financial Incentives
Best practices plus providing financial incentives contingent on biochemically verified abstinence. Incentives are in the form of vouchers exchangeable for retail items and available through 12-weeks postpartum.
Best practices
financial incentives: financial incentives provided contingent on biochemically confirmed smoking abstinence
|
Never-smoker Comparison Condition
We will follow a group of never-smoker pregnant women matched to smokers on key sociodemographic and obstetrical characteristics for purposes of comparisons in birth/health outcomes at delivery and through 1 year postpartum
|
|---|---|---|---|
|
Incremental Cost Effectiveness Ratio (ICER)
|
23511 dollars per years gained
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: at deliveryPopulation: Birth outcomes were obtained for 88, 76, and 79 infants of mothers in best practices, best practices plus financial incentives, and never-smokers.
Birth weight was obtained for each infant from the birth record and expressed in grams. We report the group mean and standard error for each treatment condition.
Outcome measures
| Measure |
Best Practices for Pregnant Smokers
n=88 Participants
Five As plus referral to pregnancy-specific tobacco quit line
Best practices
|
Best Practices Plus Financial Incentives
n=76 Participants
Best practices plus providing financial incentives contingent on biochemically verified abstinence. Incentives are in the form of vouchers exchangeable for retail items and available through 12-weeks postpartum.
Best practices
financial incentives: financial incentives provided contingent on biochemically confirmed smoking abstinence
|
Never-smoker Comparison Condition
n=79 Participants
We will follow a group of never-smoker pregnant women matched to smokers on key sociodemographic and obstetrical characteristics for purposes of comparisons in birth/health outcomes at delivery and through 1 year postpartum
|
|---|---|---|---|
|
Additional Birth Outcome: Mean Birth Weight
|
3176.39 weight (grams)
Standard Error 46.74
|
3214.84 weight (grams)
Standard Error 50.11
|
3391.14 weight (grams)
Standard Error 49.64
|
Adverse Events
Best Practices for Pregnant Smokers
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
Best Practices Plus Financial Incentives
Serious events: 4 serious events
Other events: 0 other events
Deaths: 0 deaths
Never-smoker Comparison Condition
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Best Practices for Pregnant Smokers
n=91 participants at risk
Five As plus referral to pregnancy-specific tobacco quit line
Best practices
|
Best Practices Plus Financial Incentives
n=85 participants at risk
Best practices plus providing financial incentives contingent on biochemically verified abstinence. Incentives are in the form of vouchers exchangeable for retail items and available through 12-weeks postpartum.
Best practices
financial incentives: financial incentives provided contingent on biochemically confirmed smoking abstinence
|
Never-smoker Comparison Condition
n=81 participants at risk
We will follow a group of never-smoker pregnant women matched to smokers on key sociodemographic and obstetrical characteristics for purposes of comparisons in birth/health outcomes at delivery and through 1 year postpartum
|
|---|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy termination/fetal demise
|
3.3%
3/91 • Number of events 3 • On average women were followed for 1 year, 6 months (end of 1st trimester of pregnancy through 1 year postpartum).
We report the number of instances of pregnancy termination/fetal demise per treatment condition.
|
4.7%
4/85 • Number of events 4 • On average women were followed for 1 year, 6 months (end of 1st trimester of pregnancy through 1 year postpartum).
We report the number of instances of pregnancy termination/fetal demise per treatment condition.
|
1.2%
1/81 • Number of events 1 • On average women were followed for 1 year, 6 months (end of 1st trimester of pregnancy through 1 year postpartum).
We report the number of instances of pregnancy termination/fetal demise per treatment condition.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place