Financial Incentives for Smoking Cessation Among Disadvantaged Pregnant Women

NCT02210832 | Completed Results

• 2 other identifiers: 1R01HD075669-01R01HD075669-01
• Study Type: interventional
• Target: 257
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cigarette Smoking

Keywords

smoking; pregnancy; cessation; incentives

Outcome Measures

Primary Outcomes (1)

• 7-day Point Prevalence Abstinence Levels at Final Antepartum Assessment

  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

  collected once per women at approximately 28-weeks gestation in each of the two smoking arms

Secondary Outcomes (14)

• 7-day Point Prevalence Abstinence Postpartum

  Repeated assessments completed at 2-, 4-, 8-, 12-, 24-, and 48-weeks postpartum

• Breastfeeding in the Three Trial Arms

  Repeated assessments completed at 2-, 4-, 8-, 12-, 24-, and 48-weeks postpartum

• Breastfeeding While Abstinent From Smoking

  Repeated assessments completed at 2-, 4-, 8-, 12-, 24-, and 48-weeks postpartum

• Craving Item From the Minnesota Nicotine Withdrawal Scale (MNWS).

  Outcomes reported for 8 assessments (early pregnancy, late pregnancy, 2, 4, 8, 12, 24, 28 weeks postpartum.

• Nicotine Withdrawal Total Scores for the Two Smoking-cessation Trial Conditions.

  Outcomes reported for 8 assessments (early pregnancy, late pregnancy, 2, 4, 8, 12, 24, 28 weeks postpartum.

Other Outcomes (1)

• Additional Birth Outcome: Mean Birth Weight

  at delivery

Study Arms (3)

Best practices for pregnant smokers

EXPERIMENTAL

Five As plus referral to pregnancy-specific tobacco quit line

Behavioral: Best practices

Best practices plus financial incentives

EXPERIMENTAL

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.

Behavioral: Best practices; Behavioral: financial incentives

Never-smoker comparison condition

NO INTERVENTION

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

Best practices BEHAVIORAL

Also known as: Five As plus referral to pregnancy-specific quit line

Best practices for pregnant smokers; Best practices plus financial incentives

financial incentives BEHAVIORAL

financial incentives provided contingent on biochemically confirmed smoking abstinence

Also known as: contingency management

Best practices plus financial incentives

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• English speaking;
• plan on remaining in the geographical area through 12months postpartum.
• report being nonsmokers at the time they learned of the current pregnancy;
• report no smoking in the past 6 month;
• Biochemical verification of non-smoker status;
• report smoking \< 100 cigarettes in their lifetime;

You may not qualify if:

• \> 25 weeks gestation;
• unavailable for routine assessments through 1 year postpartum;
• opioid substitution therapy;
• untreated/unstable serious mental illness

Sponsors & Collaborators

• University of Vermont: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• Centers for Disease Control and Prevention: collaborator

Study Sites (1)

University of Vermont, University Health Center Campus

Burlington, Vermont, 05401, United States

Location

Related Publications (3)

• 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: 22227223 BACKGROUND

• 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: 35533885 DERIVED

• 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.

  PMID: 35248683 DERIVED

MeSH Terms

Conditions

Cigarette Smoking; Smoking

Interventions

Practice Guidelines as Topic

Condition Hierarchy (Ancestors)

Tobacco Smoking; Behavior; Tobacco Use

Intervention Hierarchy (Ancestors)

Guidelines as Topic; Quality Assurance, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Stephen T. Higgins
• Organization: University of Vermont

stephen.higgins@uvm.edu

802-735-6267

Study Officials

• Stephen T Higgins, PhD

  University of Vermont

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry and Psychology

Study Record Dates

• First Submitted: July 31, 2014
• First Posted: August 7, 2014
• Study Start: January 31, 2014
• Primary Completion: January 31, 2019
• Study Completion: January 31, 2020
• Last Updated: August 24, 2023
• Results First Posted: August 24, 2023

Record last verified: 2023-05

Locations

US (1)