Ignite Creation Date:
2025-12-24 @ 9:24 PM
Ignite Modification Date:
2026-01-07 @ 3:45 AM
Study NCT ID:
NCT02210832
Status:
COMPLETED
Last Update Posted:
2023-08-24
First Post:
2014-07-31
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Financial Incentives for Smoking Cessation Among Disadvantaged Pregnant Women
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000073865', 'term': 'Cigarette Smoking'}, {'id': 'D012907', 'term': 'Smoking'}], 'ancestors': [{'id': 'D000073869', 'term': 'Tobacco Smoking'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D064424', 'term': 'Tobacco Use'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017410', 'term': 'Practice Guidelines as Topic'}], 'ancestors': [{'id': 'D017408', 'term': 'Guidelines as Topic'}, {'id': 'D011785', 'term': 'Quality Assurance, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'stephen.higgins@uvm.edu', 'phone': '802-735-6267', 'title': 'Stephen T. Higgins', 'organization': 'University of Vermont'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'On average women were followed for 1 year, 6 months (end of 1st trimester of pregnancy through 1 year postpartum).', 'description': 'We report the number of instances of pregnancy termination/fetal demise per treatment condition.', 'eventGroups': [{'id': 'EG000', 'title': 'Best Practices for Pregnant Smokers', 'description': 'Five As plus referral to pregnancy-specific tobacco quit line\n\nBest practices', 'otherNumAtRisk': 91, 'deathsNumAtRisk': 91, 'otherNumAffected': 0, 'seriousNumAtRisk': 91, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'Best Practices Plus Financial Incentives', 'description': '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.\n\nBest practices\n\nfinancial incentives: financial incentives provided contingent on biochemically confirmed smoking abstinence', 'otherNumAtRisk': 85, 'deathsNumAtRisk': 85, 'otherNumAffected': 0, 'seriousNumAtRisk': 85, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG002', 'title': 'Never-smoker Comparison Condition', 'description': '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', 'otherNumAtRisk': 81, 'deathsNumAtRisk': 81, 'otherNumAffected': 0, 'seriousNumAtRisk': 81, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'seriousEvents': [{'term': 'Pregnancy termination/fetal demise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': '7-day Point Prevalence Abstinence Levels at Final Antepartum Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Best Practices for Pregnant Smokers', 'description': 'Five As plus referral to pregnancy-specific tobacco quit line\n\nBest practices'}, {'id': 'OG001', 'title': 'Best Practices Plus Financial Incentives', 'description': '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.\n\nBest practices\n\nfinancial incentives: financial incentives provided contingent on biochemically confirmed smoking abstinence'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'p value is not adjusted for multiple comparisons. A priori threshold for significance was P \\< 0.05.', 'groupDescription': 'Hypothesized that women assigned to Best practices plus financial incentives would achieve greater abstinence than women assigned to Best practices only.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'chi square test statistic = 20.23, df = 1', 'nonInferiorityComment': '38.27% vs. 9.09%'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'collected once per women at approximately 28-weeks gestation in each of the two smoking arms', 'description': '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', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Comparison of women in two smoking-cessation arms'}, {'type': 'SECONDARY', 'title': '7-day Point Prevalence Abstinence Postpartum', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Best Practices for Pregnant Smokers', 'description': 'Five As plus referral to pregnancy-specific tobacco quit line\n\nBest practices'}, {'id': 'OG001', 'title': 'Best Practices Plus Financial Incentives', 'description': '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.\n\nBest practices\n\nfinancial incentives: financial incentives provided contingent on biochemically confirmed smoking abstinence'}], 'classes': [{'title': '2 weeks postpartum', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}]}, {'title': '4 weeks postpartum', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}]}, {'title': '8 weeks postpartum', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}, {'title': '12 weeks postpartum', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}, {'title': '24 weeks postpartum', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': '48 weeks postpartum', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Used generalized estimating equation utilizing a logistic link function with treatment condition and assessment time adjusting for covariates.'}, {'pValue': '0.003', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'chi square test statistic = 21.93, df=7', 'groupDescription': 'Trial condition by assessment time interaction', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Conducted a generalized estimating equation utilizing a logistic link function with treatment condition and assessment time adjusting for covariates.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Repeated assessments completed at 2-, 4-, 8-, 12-, 24-, and 48-weeks postpartum', 'description': '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', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Hypothesized that women assigned to Best practices plus financial incentives would achieve greater smoking abstinence than women assigned to Best practices only.'}, {'type': 'SECONDARY', 'title': 'Breastfeeding in the Three Trial Arms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Best Practices for Pregnant Smokers', 'description': 'Five As plus referral to pregnancy-specific tobacco quit line\n\nBest practices'}, {'id': 'OG001', 'title': 'Best Practices Plus Financial Incentives', 'description': '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.\n\nBest practices\n\nfinancial incentives: financial incentives provided contingent on biochemically confirmed smoking abstinence'}, {'id': 'OG002', 'title': 'Never-smoker Comparison Condition', 'description': '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'}], 'classes': [{'title': '2-weeks postpartum', 'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}]}]}, {'title': '4-weeks postpartum', 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}]}]}, {'title': '8-weeks postpartum', 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}]}]}, {'title': '12-weeks postpartum', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}]}]}, {'title': '24-weeks postpartum', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}]}]}, {'title': '48-weeks postpartum', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.48', 'groupIds': ['OG000', 'OG001', 'OG002'], 'pValueComment': 'chi square test statistic = 9.52, df = 10', 'groupDescription': 'Interaction of trial condition and time', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Conducted a generalized estimating equation utilizing a logistic link function with treatment condition and assessment time adjusting for covariates.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Repeated assessments completed at 2-, 4-, 8-, 12-, 24-, and 48-weeks postpartum', 'description': 'Compare the three trial arms on overall percentage of women continuing to breastfeed at repeated postpartum assessments', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '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'}, {'type': 'SECONDARY', 'title': 'Breastfeeding While Abstinent From Smoking', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Best Practices for Pregnant Smokers', 'description': 'Five As plus referral to pregnancy-specific tobacco quit line\n\nBest practices'}, {'id': 'OG001', 'title': 'Best Practices Plus Financial Incentives', 'description': '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.\n\nBest practices\n\nfinancial incentives: financial incentives provided contingent on biochemically confirmed smoking abstinence'}, {'id': 'OG002', 'title': 'Never-smoker Comparison Condition', 'description': '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'}], 'classes': [{'title': '2-weeks postpartum', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}]}]}, {'title': '4-weeks postpartum', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}]}]}, {'title': '8-weeks postpartum', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}]}]}, {'title': '12-weeks postpartum', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}]}]}, {'title': '24-weeks postpartum', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}]}]}, {'title': '48-weeks postpartum', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001', 'OG002'], 'pValueComment': 'chi square test statistic = 33.51, df = 2', 'groupDescription': 'Examining main effect of treatment condition.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Conducted a generalized estimating equation utilizing a logistic link function with treatment condition and assessment time adjusting for covariates.'}, {'pValue': '0.89', 'groupIds': ['OG000', 'OG001', 'OG002'], 'pValueComment': 'chi square test statistic = 5.00, df = 10.', 'groupDescription': 'Testing interaction of treatment condition and assessment time', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Repeated assessments completed at 2-, 4-, 8-, 12-, 24-, and 48-weeks postpartum', 'description': '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.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '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'}, {'type': 'SECONDARY', 'title': 'Craving Item From the Minnesota Nicotine Withdrawal Scale (MNWS).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Best Practices for Pregnant Smokers', 'description': 'Five As plus referral to pregnancy-specific tobacco quit line\n\nBest practices'}, {'id': 'OG001', 'title': 'Best Practices Plus Financial Incentives', 'description': '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.\n\nBest practices\n\nfinancial incentives: financial incentives provided contingent on biochemically confirmed smoking abstinence'}], 'classes': [{'title': 'early antepartum', 'categories': [{'measurements': [{'value': '2.73', 'spread': '0.14', 'groupId': 'OG000'}, {'value': '1.75', 'spread': '0.15', 'groupId': 'OG001'}]}]}, {'title': 'late antepartum', 'categories': [{'measurements': [{'value': '2.30', 'spread': '0.14', 'groupId': 'OG000'}, {'value': '1.52', 'spread': '0.15', 'groupId': 'OG001'}]}]}, {'title': '2 weeks postpartum', 'categories': [{'measurements': [{'value': '2.14', 'spread': '0.15', 'groupId': 'OG000'}, {'value': '1.39', 'spread': '0.16', 'groupId': 'OG001'}]}]}, {'title': '4 weeks postpartum', 'categories': [{'measurements': [{'value': '2.17', 'spread': '0.15', 'groupId': 'OG000'}, {'value': '1.55', 'spread': '0.16', 'groupId': 'OG001'}]}]}, {'title': '8 weeks postpartum', 'categories': [{'measurements': [{'value': '2.27', 'spread': '0.15', 'groupId': 'OG000'}, {'value': '1.75', 'spread': '0.16', 'groupId': 'OG001'}]}]}, {'title': '12 weeks postpartum', 'categories': [{'measurements': [{'value': '2.33', 'spread': '0.14', 'groupId': 'OG000'}, {'value': '1.72', 'spread': '0.16', 'groupId': 'OG001'}]}]}, {'title': '24 weeks postpartum', 'categories': [{'measurements': [{'value': '1.97', 'spread': '0.15', 'groupId': 'OG000'}, {'value': '1.97', 'spread': '0.16', 'groupId': 'OG001'}]}]}, {'title': '48 weeks postpartum', 'categories': [{'measurements': [{'value': '2.10', 'spread': '0.16', 'groupId': 'OG000'}, {'value': '1.99', 'spread': '0.17', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Method was mixed model repeated measures analysis of covariance.'}], 'paramType': 'MEAN', 'timeFrame': 'Outcomes reported for 8 assessments (early pregnancy, late pregnancy, 2, 4, 8, 12, 24, 28 weeks postpartum.', 'description': 'The craving item is on a 0 (none) to 4 (severe) scale. We report mean (SEM) scores.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Comparing between women assigned to the two smoking-cessation trial conditions.'}, {'type': 'SECONDARY', 'title': 'Nicotine Withdrawal Total Scores for the Two Smoking-cessation Trial Conditions.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Best Practices for Pregnant Smokers', 'description': 'Five As plus referral to pregnancy-specific tobacco quit line\n\nBest practices'}, {'id': 'OG001', 'title': 'Best Practices Plus Financial Incentives', 'description': '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.\n\nBest practices\n\nfinancial incentives: financial incentives provided contingent on biochemically confirmed smoking abstinence'}], 'classes': [{'title': 'Early antepartum', 'categories': [{'measurements': [{'value': '1.47', 'spread': '0.08', 'groupId': 'OG000'}, {'value': '1.02', 'spread': '0.08', 'groupId': 'OG001'}]}]}, {'title': 'Late antepartum', 'categories': [{'measurements': [{'value': '1.38', 'spread': '0.08', 'groupId': 'OG000'}, {'value': '0.93', 'spread': '0.08', 'groupId': 'OG001'}]}]}, {'title': '2-weeks postpartum', 'categories': [{'measurements': [{'value': '0.80', 'spread': '0.08', 'groupId': 'OG000'}, {'value': '0.70', 'spread': '0.09', 'groupId': 'OG001'}]}]}, {'title': '4-weeks postpartum', 'categories': [{'measurements': [{'value': '0.80', 'spread': '0.08', 'groupId': 'OG000'}, {'value': '0.68', 'spread': '0.09', 'groupId': 'OG001'}]}]}, {'title': '8-weeks postpartum', 'categories': [{'measurements': [{'value': '0.92', 'spread': '0.08', 'groupId': 'OG000'}, {'value': '0.68', 'spread': '0.08', 'groupId': 'OG001'}]}]}, {'title': '12-weeks postpartum', 'categories': [{'measurements': [{'value': '0.86', 'spread': '0.08', 'groupId': 'OG000'}, {'value': '0.59', 'spread': '0.08', 'groupId': 'OG001'}]}]}, {'title': '24-weeks postpartum', 'categories': [{'measurements': [{'value': '0.81', 'spread': '0.08', 'groupId': 'OG000'}, {'value': '0.78', 'spread': '0.09', 'groupId': 'OG001'}]}]}, {'title': '48-weeks postpartum', 'categories': [{'measurements': [{'value': '1.03', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '0.84', 'spread': '0.09', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'F\\[7,922\\]=3.62', 'groupDescription': 'Examine interaction of treatment condition and assessment time.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Repeated measures analysis of covariance was conducted with Bonferroni corrections for post-doc tests and across repeated assessments.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Method was mixed model repeated measures analysis of covariance.'}], 'paramType': 'MEAN', 'timeFrame': 'Outcomes reported for 8 assessments (early pregnancy, late pregnancy, 2, 4, 8, 12, 24, 28 weeks postpartum.', 'description': '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.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Comparing women assigned to the two smoking-cessation trial conditions.'}, {'type': 'SECONDARY', 'title': 'Infant Growth in First Year of Life', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Best Practices for Pregnant Smokers', 'description': 'Five As plus referral to pregnancy-specific tobacco quit line\n\nBest practices'}, {'id': 'OG001', 'title': 'Best Practices Plus Financial Incentives', 'description': '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.\n\nBest practices\n\nfinancial incentives: financial incentives provided contingent on biochemically confirmed smoking abstinence'}, {'id': 'OG002', 'title': 'Never-smoker Comparison Condition', 'description': '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'}], 'classes': [{'title': 'Birth', 'categories': [{'measurements': [{'value': '31.39', 'spread': '3.35', 'groupId': 'OG000'}, {'value': '34.92', 'spread': '3.51', 'groupId': 'OG001'}, {'value': '40.56', 'spread': '3.20', 'groupId': 'OG002'}]}]}, {'title': '24-weeks postpartum', 'categories': [{'measurements': [{'value': '56.19', 'spread': '3.36', 'groupId': 'OG000'}, {'value': '59.14', 'spread': '3.71', 'groupId': 'OG001'}, {'value': '46.15', 'spread': '3.39', 'groupId': 'OG002'}]}]}, {'title': '48-weeks postpartum', 'categories': [{'measurements': [{'value': '65.97', 'spread': '3.73', 'groupId': 'OG000'}, {'value': '65.69', 'spread': '4.06', 'groupId': 'OG001'}, {'value': '66.62', 'spread': '3.47', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.009', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Method was mixed model repeated measures analysis of covariance.'}], 'paramType': 'MEAN', 'timeFrame': 'delivery, 24-week, and 50-week postpartum assessments', 'description': 'Infant growth (length \\& weight) expressed a Body Mass Index (BMI) percentile score was assessed at delivery, 24- and 48-week postpartum assessments.', 'unitOfMeasure': 'BMI Percentile', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Birth Outcomes (% Small for Gestational Age Deliveries)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}, {'value': '79', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Best Practices for Pregnant Smokers', 'description': 'Five As plus referral to pregnancy-specific tobacco quit line\n\nBest practices'}, {'id': 'OG001', 'title': 'Best Practices Plus Financial Incentives', 'description': '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.\n\nBest practices\n\nfinancial incentives: financial incentives provided contingent on biochemically confirmed smoking abstinence'}, {'id': 'OG002', 'title': 'Never-smoker Comparison Condition', 'description': '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'}], 'classes': [{'categories': [{'title': 'Small for Gestational Age', 'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}, {'title': 'Normal size for gestational age', 'measurements': [{'value': '72', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.01', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Method is logistic regression adjusted for covariates.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'delivery', 'description': '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/.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Comparison of three trial conditions on SGA deliveries'}, {'type': 'SECONDARY', 'title': 'Birth Outcomes (Percent Preterm [<37 Weeks] Deliveries)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}, {'value': '79', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Best Practices for Pregnant Smokers', 'description': 'Five As plus referral to pregnancy-specific tobacco quit line\n\nBest practices'}, {'id': 'OG001', 'title': 'Best Practices Plus Financial Incentives', 'description': '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.\n\nBest practices\n\nfinancial incentives: financial incentives provided contingent on biochemically confirmed smoking abstinence'}, {'id': 'OG002', 'title': 'Never-smoker Comparison Condition', 'description': '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'}], 'classes': [{'categories': [{'title': 'preterm', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}, {'title': '>/= 37 weeks', 'measurements': [{'value': '82', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'at delivery', 'description': 'Compared the three trials conditions on preterm deliveries.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Birth Outcomes (NICU Admissions)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}, {'value': '79', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Best Practices for Pregnant Smokers', 'description': 'Five As plus referral to pregnancy-specific tobacco quit line\n\nBest practices'}, {'id': 'OG001', 'title': 'Best Practices Plus Financial Incentives', 'description': '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.\n\nBest practices\n\nfinancial incentives: financial incentives provided contingent on biochemically confirmed smoking abstinence'}, {'id': 'OG002', 'title': 'Never-smoker Comparison Condition', 'description': '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'}], 'classes': [{'title': 'NICU admitted', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}]}, {'title': 'no NICU', 'categories': [{'measurements': [{'value': '77', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}, {'value': '68', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'at delivery', 'description': 'Compared three trial conditions on percent of NICU admissions', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Compared three trial conditions on NICU admissions.'}, {'type': 'SECONDARY', 'title': 'Ages & Stages Questionnaire (ASQ)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '68', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Best Practices for Pregnant Smokers', 'description': 'Five As plus referral to pregnancy-specific tobacco quit line\n\nBest practices'}, {'id': 'OG001', 'title': 'Best Practices Plus Financial Incentives', 'description': '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.\n\nBest practices\n\nfinancial incentives: financial incentives provided contingent on biochemically confirmed smoking abstinence'}, {'id': 'OG002', 'title': 'Never-smoker Comparison Condition', 'description': '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'}], 'classes': [{'title': 'Comm at 24-weeks', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Comm at 48-weeks', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'GM at 24-weeks', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}]}, {'title': 'GM at 48-weeks', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}]}, {'title': 'FM at 24-weeks', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}]}, {'title': 'FM at 48-weeks', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}, {'title': 'PrbSlv at 24-weeks', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}]}, {'title': 'PrbSlv at 48-weeks', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}]}, {'title': 'PerSoc at 24-weeks', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}]}, {'title': 'PerSoc at 48-weeks', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '24- and 48-weeks postpartum', 'description': '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.', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Birth Outcome: Gestational Age at Delivery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}, {'value': '79', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Best Practices for Pregnant Smokers', 'description': 'Five As plus referral to pregnancy-specific tobacco quit line\n\nBest practices'}, {'id': 'OG001', 'title': 'Best Practices Plus Financial Incentives', 'description': '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.\n\nBest practices\n\nfinancial incentives: financial incentives provided contingent on biochemically confirmed smoking abstinence'}, {'id': 'OG002', 'title': 'Never-smoker Comparison Condition', 'description': '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'}], 'classes': [{'categories': [{'measurements': [{'value': '39.18', 'spread': '0.22', 'groupId': 'OG000'}, {'value': '38.69', 'spread': '0.23', 'groupId': 'OG001'}, {'value': '39.35', 'spread': '0.22', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'at delivery', 'description': 'Birth outcomes were obtained from the birth record. Gestational age was expressed in weeks.', 'unitOfMeasure': 'gestational age (weeks)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Cost Per Participant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Best Practices Plus Financial Incentives', 'description': '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.\n\nBest practices Financial incentives: financial incentives provided contingent on biochemically confirmed smoking abstinence'}, {'id': 'OG001', 'title': 'Best Practices', 'description': 'Best Practices: 5As plus referral to tobacco quit line'}], 'classes': [{'categories': [{'measurements': [{'value': '23007.01', 'spread': '1284.83', 'groupId': 'OG000'}, {'value': '22372.25', 'spread': '1594.23', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Trial entry through 24-weeks postpartum (approximately one year following smoking-cessation quit date).', 'description': '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.', 'unitOfMeasure': 'U.S. dollars', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants treated in best practices plus financial incentives and best practices trial conditions.'}, {'type': 'SECONDARY', 'title': 'Quality of Life Years Gained (QALYs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '169', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Combined Best Practices and Best Practices Plus Financial Incentives', 'description': 'Best practices: Five As plus referral to pregnancy-specific tobacco quit line\n\nBest 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.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0267', 'spread': '0.0412', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 weeks postpartum', 'description': '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.', 'unitOfMeasure': 'net years gained', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Incremental Cost Effectiveness Ratio (ICER)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '169', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Combined Best Practices and Best Practices Plus Financial Incentives', 'description': 'Best practices: Five As plus referral to pregnancy-specific tobacco quit line\n\nBest 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.'}], 'classes': [{'categories': [{'measurements': [{'value': '23511', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '24 weeks postpartum', 'description': "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.", 'unitOfMeasure': 'dollars per years gained', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Additional Birth Outcome: Mean Birth Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}, {'value': '79', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Best Practices for Pregnant Smokers', 'description': 'Five As plus referral to pregnancy-specific tobacco quit line\n\nBest practices'}, {'id': 'OG001', 'title': 'Best Practices Plus Financial Incentives', 'description': '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.\n\nBest practices\n\nfinancial incentives: financial incentives provided contingent on biochemically confirmed smoking abstinence'}, {'id': 'OG002', 'title': 'Never-smoker Comparison Condition', 'description': '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'}], 'classes': [{'categories': [{'measurements': [{'value': '3176.39', 'spread': '46.74', 'groupId': 'OG000'}, {'value': '3214.84', 'spread': '50.11', 'groupId': 'OG001'}, {'value': '3391.14', 'spread': '49.64', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.006', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'All comparisons adjusted for infant gestational age at time of delivery.'}], 'paramType': 'MEAN', 'timeFrame': 'at delivery', 'description': '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.', 'unitOfMeasure': 'weight (grams)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Birth outcomes were obtained for 88, 76, and 79 infants of mothers in best practices, best practices plus financial incentives, and never-smokers.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Best Practices for Pregnant Smokers', 'description': 'Five As plus referral to pregnancy-specific tobacco quit line\n\nBest practices'}, {'id': 'FG001', 'title': 'Best Practices Plus Financial Incentives', 'description': '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.\n\nBest practices\n\nfinancial incentives: financial incentives provided contingent on biochemically confirmed smoking abstinence'}, {'id': 'FG002', 'title': 'Never-smoker Comparison Condition', 'description': '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'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '91'}, {'groupId': 'FG001', 'numSubjects': '85'}, {'groupId': 'FG002', 'numSubjects': '81'}]}, {'type': 'COMPLETED', 'comment': 'Defined as completed week-48 postpartum assessment.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '62'}, {'groupId': 'FG001', 'numSubjects': '49'}, {'groupId': 'FG002', 'numSubjects': '63'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '36'}, {'groupId': 'FG002', 'numSubjects': '18'}]}], 'dropWithdraws': [{'type': 'Pregnancy termination .', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '32'}, {'groupId': 'FG002', 'numSubjects': '17'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'BG000'}, {'value': '81', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}, {'value': '249', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Best Practices for Pregnant Smokers', 'description': 'Five As plus referral to pregnancy-specific tobacco quit line\n\nBest practices'}, {'id': 'BG001', 'title': 'Best Practices Plus Financial Incentives', 'description': '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.\n\nBest practices\n\nfinancial incentives: financial incentives provided contingent on biochemically confirmed smoking abstinence'}, {'id': 'BG002', 'title': 'Never-smoker Comparison Condition', 'description': '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'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '26.6', 'spread': '5.5', 'groupId': 'BG000'}, {'value': '25.4', 'spread': '5.0', 'groupId': 'BG001'}, {'value': '25.6', 'spread': '5.0', 'groupId': 'BG002'}, {'value': '25.87', 'spread': '5.17', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '88', 'groupId': 'BG000'}, {'value': '81', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}, {'value': '249', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '82', 'groupId': 'BG000'}, {'value': '74', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}, {'value': '228', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '88', 'groupId': 'BG000'}, {'value': '81', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}, {'value': '249', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Cigarettes smoked per day pre-pregnancy', 'classes': [{'categories': [{'measurements': [{'value': '18.27', 'spread': '9.42', 'groupId': 'BG000'}, {'value': '19.25', 'spread': '9.87', 'groupId': 'BG001'}, {'value': '0', 'spread': '0', 'groupId': 'BG002'}, {'value': '12.51', 'spread': '6.43', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cigarettes/day', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Cigarettes smoked per day at 1st antepartum visit', 'classes': [{'categories': [{'measurements': [{'value': '9.92', 'spread': '6.18', 'groupId': 'BG000'}, {'value': '8.99', 'spread': '5.21', 'groupId': 'BG001'}, {'value': '0', 'spread': '0', 'groupId': 'BG002'}, {'value': '6.30', 'spread': '3.80', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cigarettes/day', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age started smoking (yrs)', 'classes': [{'categories': [{'measurements': [{'value': '15.47', 'spread': '2.96', 'groupId': 'BG000'}, {'value': '15.10', 'spread': '2.92', 'groupId': 'BG001'}, {'value': '0', 'spread': '0', 'groupId': 'BG002'}, {'value': '10.19', 'spread': '1.96', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': '% living with other smokers', 'classes': [{'categories': [{'measurements': [{'value': '68', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '150', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': '% with no smoking allowed in home', 'classes': [{'categories': [{'measurements': [{'value': '62', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '73', 'groupId': 'BG002'}, {'value': '190', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': '% with none or few family who smoke', 'classes': [{'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}, {'value': '105', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': '% attempted to quit prepregnancy', 'classes': [{'categories': [{'measurements': [{'value': '64', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '121', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': '# quit attempts during pregnancy', 'classes': [{'categories': [{'measurements': [{'value': '0.73', 'spread': '2.35', 'groupId': 'BG000'}, {'value': '0.57', 'spread': '0.97', 'groupId': 'BG001'}, {'value': '0', 'spread': '0', 'groupId': 'BG002'}, {'value': '0.43', 'spread': '1.11', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'attempts', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Minnesota Nicotine Withdrawal Scale total score; scale: 0 (none) to 4 (severe);average item scores', 'classes': [{'categories': [{'measurements': [{'value': '1.60', 'spread': '0.75', 'groupId': 'BG000'}, {'value': '1.37', 'spread': '0.76', 'groupId': 'BG001'}, {'value': '0', 'spread': '0', 'groupId': 'BG002'}, {'value': '0.99', 'spread': '0.50', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Minnesota Nicotine Withdrawal Scale We report mean Total Scores (minimum = 0 \\[no discomfort\\], maximum = 4 \\[severe discomfort\\]) There are 8 scale items, each is scored 0 to 4. Total Scores reflect the average of the eight items.\n\nWe report the average the average Total Score and standard deviation in each treatment condition.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Fagerstrom Test for Nicotine Dependence', 'classes': [{'categories': [{'measurements': [{'value': '4.33', 'spread': '2.30', 'groupId': 'BG000'}, {'value': '3.98', 'spread': '2.07', 'groupId': 'BG001'}, {'value': '0', 'spread': '0', 'groupId': 'BG002'}, {'value': '2.77', 'spread': '1.46', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'The Fagerstrom Test for Nicotine Dependence is a 6-item scale Four items are scored Yes-No with Yes = 1 and No = 0. Two items have four response options each scored 1-4 with lower scores indicating less dependence Items are summed for each test taker to get a total score with a range of 0 (no dependence) to 10 (intense dependence).\n\nWe report the average participant score and standard deviation for each treatment condition.', 'unitOfMeasure': '0-10 scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': '% endorsing that smoking will greatly harm baby', 'classes': [{'categories': [{'measurements': [{'value': '70', 'groupId': 'BG000'}, {'value': '69', 'groupId': 'BG001'}, {'value': '79', 'groupId': 'BG002'}, {'value': '218', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Item is scored on 0 (not at all) to 4 (a lot); there is a "don\'t know" item that is recoded as missing. Scale is dichotomized by collapsing items 1-3 vs. 4. We report the number of participants indicating a score of 4.', 'unitOfMeasure': 'Participants'}, {'title': 'Stress rating scale for past week from 0 (none) to 10 (extreme)', 'classes': [{'categories': [{'measurements': [{'value': '6.3', 'spread': '2.2', 'groupId': 'BG000'}, {'value': '5.0', 'spread': '2.5', 'groupId': 'BG001'}, {'value': '3.3', 'spread': '2.1', 'groupId': 'BG002'}, {'value': '4.9', 'spread': '2.3', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': "This is a single item scale on which each participant rates their past week's stress as 0 (none) to 10 (extreme). We report the mean score and standard deviation for each treatment condition.", 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Beck Depression Inventory total score', 'classes': [{'categories': [{'measurements': [{'value': '12.8', 'spread': '8.6', 'groupId': 'BG000'}, {'value': '10.0', 'spread': '7.4', 'groupId': 'BG001'}, {'value': '5.8', 'spread': '5.2', 'groupId': 'BG002'}, {'value': '9.5', 'spread': '7.1', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'The Beck Depression Inventory contains items 21 items each scored 0 (least) to 3 (most). Item scores are summed for a total score ranging from 0-63. We report the mean total score and standard deviation for each treatment condition.', 'unitOfMeasure': 'units on a 0-63 scale', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Women who aborted were removed from the study as per convention in this research area. A total of 8 women were removed for this reason, 3, 4, and 1 in Best practices for pregnant smokers, Best practices plus financial incentives, and Never-smoker comparison conditions.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-09-01', 'size': 294594, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-05-11T09:09', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 257}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01-31'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2020-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-10', 'studyFirstSubmitDate': '2014-07-31', 'resultsFirstSubmitDate': '2021-11-10', 'studyFirstSubmitQcDate': '2014-08-05', 'lastUpdatePostDateStruct': {'date': '2023-08-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-08-10', 'studyFirstPostDateStruct': {'date': '2014-08-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2023-08-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Additional Birth Outcome: Mean Birth Weight', 'timeFrame': 'at delivery', 'description': '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.'}], 'primaryOutcomes': [{'measure': '7-day Point Prevalence Abstinence Levels at Final Antepartum Assessment', 'timeFrame': 'collected once per women at approximately 28-weeks gestation in each of the two smoking arms', 'description': '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'}], 'secondaryOutcomes': [{'measure': '7-day Point Prevalence Abstinence Postpartum', 'timeFrame': 'Repeated assessments completed at 2-, 4-, 8-, 12-, 24-, and 48-weeks postpartum', 'description': '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'}, {'measure': 'Breastfeeding in the Three Trial Arms', 'timeFrame': 'Repeated assessments completed at 2-, 4-, 8-, 12-, 24-, and 48-weeks postpartum', 'description': 'Compare the three trial arms on overall percentage of women continuing to breastfeed at repeated postpartum assessments'}, {'measure': 'Breastfeeding While Abstinent From Smoking', 'timeFrame': 'Repeated assessments completed at 2-, 4-, 8-, 12-, 24-, and 48-weeks postpartum', 'description': '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.'}, {'measure': 'Craving Item From the Minnesota Nicotine Withdrawal Scale (MNWS).', 'timeFrame': 'Outcomes reported for 8 assessments (early pregnancy, late pregnancy, 2, 4, 8, 12, 24, 28 weeks postpartum.', 'description': 'The craving item is on a 0 (none) to 4 (severe) scale. We report mean (SEM) scores.'}, {'measure': 'Nicotine Withdrawal Total Scores for the Two Smoking-cessation Trial Conditions.', 'timeFrame': 'Outcomes reported for 8 assessments (early pregnancy, late pregnancy, 2, 4, 8, 12, 24, 28 weeks postpartum.', 'description': '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.'}, {'measure': 'Infant Growth in First Year of Life', 'timeFrame': 'delivery, 24-week, and 50-week postpartum assessments', 'description': 'Infant growth (length \\& weight) expressed a Body Mass Index (BMI) percentile score was assessed at delivery, 24- and 48-week postpartum assessments.'}, {'measure': 'Birth Outcomes (% Small for Gestational Age Deliveries)', 'timeFrame': 'delivery', 'description': '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/.'}, {'measure': 'Birth Outcomes (Percent Preterm [<37 Weeks] Deliveries)', 'timeFrame': 'at delivery', 'description': 'Compared the three trials conditions on preterm deliveries.'}, {'measure': 'Birth Outcomes (NICU Admissions)', 'timeFrame': 'at delivery', 'description': 'Compared three trial conditions on percent of NICU admissions'}, {'measure': 'Ages & Stages Questionnaire (ASQ)', 'timeFrame': '24- and 48-weeks postpartum', 'description': '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.'}, {'measure': 'Birth Outcome: Gestational Age at Delivery', 'timeFrame': 'at delivery', 'description': 'Birth outcomes were obtained from the birth record. Gestational age was expressed in weeks.'}, {'measure': 'Cost Per Participant', 'timeFrame': 'Trial entry through 24-weeks postpartum (approximately one year following smoking-cessation quit date).', 'description': '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.'}, {'measure': 'Quality of Life Years Gained (QALYs)', 'timeFrame': '24 weeks postpartum', 'description': '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.'}, {'measure': 'Incremental Cost Effectiveness Ratio (ICER)', 'timeFrame': '24 weeks postpartum', 'description': "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."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['smoking', 'pregnancy', 'cessation', 'incentives'], 'conditions': ['Cigarette Smoking']}, 'referencesModule': {'references': [{'pmid': '22227223', 'type': 'BACKGROUND', 'citation': 'Higgins ST, Washio Y, Heil SH, Solomon LJ, Gaalema DE, Higgins TM, Bernstein IM. Financial incentives for smoking cessation among pregnant and newly postpartum women. Prev Med. 2012 Nov;55 Suppl(Suppl):S33-40. doi: 10.1016/j.ypmed.2011.12.016. Epub 2011 Dec 27.'}, {'pmid': '35533885', 'type': 'DERIVED', 'citation': 'Shepard DS, Slade EP, Nighbor TD, DeSarno MJ, Roemhildt ML, Williams RK, Higgins ST. Economic analysis of financial incentives for smoking cessation during pregnancy and postpartum. Prev Med. 2022 Dec;165(Pt B):107079. doi: 10.1016/j.ypmed.2022.107079. Epub 2022 May 6.'}, {'pmid': '35248683', 'type': 'DERIVED', 'citation': "Higgins ST, Nighbor TD, Kurti AN, Heil SH, Slade EP, Shepard DS, Solomon LJ, Lynch ME, Johnson HK, Markesich C, Rippberger PL, Skelly JM, DeSarno M, Bunn J, Hammond JB, Roemhildt ML, Williams RK, O'Reilly DM, Bernstein IM. Randomized Controlled Trial Examining the Efficacy of Adding Financial Incentives to Best practices for Smoking Cessation Among pregnant and Newly postpartum Women. Prev Med. 2022 Dec;165(Pt B):107012. doi: 10.1016/j.ypmed.2022.107012. Epub 2022 Mar 3."}]}, 'descriptionModule': {'briefSummary': 'Investigators will examine whether adding financial incentives to current best practices for smoking cessation during pregnancy (i.e., referral to pregnancy-specific counseling using a telephone quit line) increases cessation rates and improves infant health. While more expensive upfront compared to best practices alone, the investigators hypothesize that this treatment approach will be economically justified by the later cost savings associated with more women quitting, having healthier babies, and needing less healthcare. It should also help to reduce the greater risk for health problems often seen among those who less well off economically.', 'detailedDescription': 'Smoking during pregnancy is the leading preventable cause of poor pregnancy outcomes in the U.S. Most pregnant smokers continue smoking through pregnancy producing serious immediate and longer-term adverse health consequences for the infant. Smoking during pregnancy is highly associated with economic disadvantage and a substantive contributor to health disparities.\n\nEfficacious interventions are available, but cessation rates are low (\\<20%) and improvements in birth outcomes often modest or absent. Current treatments usually entail relatively brief, lower-cost interventions (e.g., pregnancy specific quit lines). There is broad consensus that more effective interventions are sorely needed. This team of investigators has developed a novel behavioral economic intervention in which women earn financial incentives contingent on smoking abstinence. In a metaanalysis of treatments for smoking during pregnancy, effect sizes achieved with financial incentives were several fold larger than those achieved with lower intensity approaches or medications. The intervention also appears to improve birth outcomes and increase breastfeeding duration. While highly promising, further research is needed in at least three areas. (1) The evidence on birth outcomes and breastfeeding is from studies that combined data across trials rather than a single prospective trial, (2) whether the intervention produces other postpartum improvements in health has not been investigated, and (3) the overall cost-effectiveness of this approach has not been examined.\n\nTo examine these unanswered questions, the investigators are proposing a randomized, controlled clinical trial comparing the efficacy and cost effectiveness through one year postpartum of current best practices for smoking cessation during pregnancy vs. best practices plus financial incentives among 230 pregnant, Medicaid recipients. A third condition of 115 pregnant nonsmokers matched to the smokers on sociodemographic and health conditions will be included as well to compare the extent to which the treatments reduce the burden of smoking and to estimate how much more might be accomplished by further improvements in this incentives intervention without exceeding cost-effectiveness.\n\nThe investigators hypothesize that best practices plus financial incentives will be more effective than usual care practices alone, that the incentives intervention will be cost effective, and that while adding the incentives reduces a greater proportion of the health and economic burden of smoking than best practices alone, more can be done while remaining cost effective.\n\nOverall, the proposed study has the potential to substantially advance knowledge on cost-effective smoking cessation for pregnant women. Importantly, because of the strong association between smoking during pregnancy and economic disadvantage, the proposed study also has the potential to contribute new knowledge relevant to reducing the serious challenges of health disparities.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria for two intervention arms:\n\n* report being smokers at the time that they learned of the current pregnancy;\n* report smoking in the 7 days prior to the first prenatal care visit with biochemical verification;\n* \\< 25 weeks gestation;\n* English speaking;\n* plan on remaining in the geographical area through 12months postpartum.\n\nInclusion Criteria for never-smoker comparison condition:\n\n* report being nonsmokers at the time they learned of the current pregnancy;\n* report no smoking in the past 6 month;\n* Biochemical verification of non-smoker status;\n* report smoking \\< 100 cigarettes in their lifetime;\n\nExclusion criteria:\n\n* \\> 25 weeks gestation;\n* unavailable for routine assessments through 1 year postpartum;\n* opioid substitution therapy;\n* untreated/unstable serious mental illness'}, 'identificationModule': {'nctId': 'NCT02210832', 'briefTitle': 'Financial Incentives for Smoking Cessation Among Disadvantaged Pregnant Women', 'organization': {'class': 'OTHER', 'fullName': 'University of Vermont'}, 'officialTitle': 'Financial Incentives for Smoking Cessation Among Disadvantaged Pregnant', 'orgStudyIdInfo': {'id': '1R01HD075669-01', 'link': 'https://reporter.nih.gov/quickSearch/1R01HD075669-01', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': 'R01HD075669-01', 'link': 'https://reporter.nih.gov/quickSearch/R01HD075669-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Best practices for pregnant smokers', 'description': 'Five As plus referral to pregnancy-specific tobacco quit line', 'interventionNames': ['Behavioral: Best practices']}, {'type': 'EXPERIMENTAL', 'label': 'Best practices plus financial incentives', 'description': '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.', 'interventionNames': ['Behavioral: Best practices', 'Behavioral: financial incentives']}, {'type': 'NO_INTERVENTION', 'label': 'Never-smoker comparison condition', 'description': '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'}], 'interventions': [{'name': 'Best practices', 'type': 'BEHAVIORAL', 'otherNames': ['Five As plus referral to pregnancy-specific quit line'], 'armGroupLabels': ['Best practices for pregnant smokers', 'Best practices plus financial incentives']}, {'name': 'financial incentives', 'type': 'BEHAVIORAL', 'otherNames': ['contingency management'], 'description': 'financial incentives provided contingent on biochemically confirmed smoking abstinence', 'armGroupLabels': ['Best practices plus financial incentives']}]}, 'contactsLocationsModule': {'locations': [{'zip': '05401', 'city': 'Burlington', 'state': 'Vermont', 'country': 'United States', 'facility': 'University of Vermont, University Health Center Campus', 'geoPoint': {'lat': 44.47588, 'lon': -73.21207}}], 'overallOfficials': [{'name': 'Stephen T Higgins, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Vermont'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Vermont', 'class': 'OTHER'}, 'collaborators': [{'name': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)', 'class': 'NIH'}, {'name': 'Centers for Disease Control and Prevention', 'class': 'FED'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Psychiatry and Psychology', 'investigatorFullName': 'Stephen T. Higgins, PhD', 'investigatorAffiliation': 'University of Vermont'}}}}