N/A
N=257
Financial Incentives for Smoking Cessation Among Disadvantaged Pregnant Women
Cigarette Smoking
Bottom Line
View on ClinicalTrials.gov: NCT02210832 ↗Enrolled (actual)
257
Serious AEs
3.1%
Results posted
Aug 2023
Primary outcome: Primary: 7-day Point Prevalence Abstinence Levels at Final Antepartum Assessment — 8; 31 Participants — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Best practices (Behavioral); financial incentives (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of Vermont
- Primary completion
- Jan 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 7-day Point Prevalence Abstinence Levels at Final Antepartum Assessment |
8; 31 | <0.001 sig |
| SECONDARY 7-day Point Prevalence Abstinence Postpartum |
17; 31; 14; 30; 12; 25 | <0.05 sig |
| SECONDARY Breastfeeding in the Three Trial Arms |
49; 50; 59; 40; 40; 56 | 0.48 |
| SECONDARY Breastfeeding While Abstinent From Smoking |
15; 29; 59; 11; 24; 56 | <0.0001 sig |
| SECONDARY Craving Item From the Minnesota Nicotine Withdrawal Scale (MNWS). |
2.73; 1.75; 2.30; 1.52; 2.14; 1.39 | <0.001 sig |
| SECONDARY Nicotine Withdrawal Total Scores for the Two Smoking-cessation Trial Conditions. |
1.47; 1.02; 1.38; 0.93; 0.80; 0.70 | <0.001 sig |
| SECONDARY Infant Growth in First Year of Life |
31.39; 34.92; 40.56; 56.19; 59.14; 46.15 | 0.009 sig |
| SECONDARY Birth Outcomes (% Small for Gestational Age Deliveries) |
16; 8; 2; 72; 68; 77 | 0.01 sig |
| SECONDARY Birth Outcomes (Percent Preterm [<37 Weeks] Deliveries) |
6; 10; 6; 82; 66; 73 | <0.05 sig |
| SECONDARY Birth Outcomes (NICU Admissions) |
11; 10; 11; 77; 66; 68 | <0.05 sig |
| SECONDARY Ages & Stages Questionnaire (ASQ) |
1; 2; 3; 2; 0; 3 | — |
| SECONDARY Birth Outcome: Gestational Age at Delivery |
39.18; 38.69; 39.35 | <0.05 sig |
| SECONDARY Cost Per Participant |
23007.01; 22372.25 | — |
| SECONDARY Quality of Life Years Gained (QALYs) |
0.0267 | — |
| SECONDARY Incremental Cost Effectiveness Ratio (ICER) |
23511 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria for two intervention arms:
- report being smokers at the time that they learned of the current pregnancy;
- report smoking in the 7 days prior to the first prenatal care visit with biochemical verification;
- 25 weeks gestation;
- unavailable for routine assessments through 1 year postpartum;
- opioid substitution therapy;
- untreated/unstable serious mental illness
Data sourced from ClinicalTrials.gov (NCT02210832). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.