Financial Incentives for Smoking Cessation in Pregnancy

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Oklahoma

Disqualifiers: Not pregnant, Non-smoker, Under 18, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

100 Participants Needed

Trial Summary

What is the purpose of this trial?

Although many women initially quit smoking during pregnancy, most will return to smoking by the end of pregnancy or during the first 6 months postpartum. The proposed pilot project is designed to evaluate the feasibility and potential efficacy of offering small financial incentives for the completion of smoking cessation coaching and biochemically-verified smoking abstinence at follow-up among pregnant women with Medicaid insurance who contact the Oklahoma Tobacco Helpline (OTH). The study will enroll 100 pregnant women who will be randomly assigned to OTH care or OTH plus escalating incentives (OTH+I) for completing up to 5 coaching calls over the first 8 weeks after enrolling (prepartum) and for biochemically-verified smoking abstinence at 9 weeks post-enrollment (assessed remotely via smartphone). In addition, participants will be incentivized for completing a postpartum coaching call by 8 weeks postpartum. Feasibility outcomes for the incentives based intervention will focus on coaching call completion, rates of prepartum and postpartum follow-up, biochemically-verified smoking cessation, and perceptions of the intervention. Potential effectiveness will be evaluated by comparing biochemically-verified smoking abstinence rates in OTH+I relative to OTH alone at 12 weeks post-enrollment (prepartum) and 12 weeks postpartum.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on smoking cessation and does not mention any medication restrictions.

What data supports the effectiveness of the treatment Standard Care + Financial Incentives for smoking cessation in pregnancy?

Research shows that financial incentives are the most effective way to help pregnant women quit smoking, as they increase engagement in smoking cessation programs and improve the chances of staying smoke-free for six months after birth. ^{1 2 3 4 5}

Is it safe to use financial incentives for smoking cessation during pregnancy?

The research does not specifically address safety concerns, but financial incentives for smoking cessation have been studied in pregnant women without reported safety issues. ^{1 2 4 6 7}

How does the treatment of Standard Care + Financial Incentives for smoking cessation in pregnancy differ from other treatments?

This treatment is unique because it combines standard care with financial incentives to encourage pregnant women to quit smoking, which has been shown to be the most effective intervention for smoking cessation during pregnancy. Unlike other treatments, it directly motivates behavior change through monetary rewards, making it both effective and cost-effective. ^{3 4 6 7 8}

Eligibility Criteria

This trial is for pregnant women under 25 weeks along, who smoke at least 5 cigarettes daily, are over 18 years old, speak English, and have Medicaid. They must be seeking smoking cessation treatment through the Oklahoma Tobacco Helpline and willing to enroll in a program involving multiple calls.

Inclusion Criteria

are able to read, speak, and understand English

I can provide a photo ID.

contact the Oklahoma Tobacco Helpline seeking smoking cessation treatment, and enroll in the multiple call program

Exclusion Criteria

participants will be excluded if they do not meet the inclusion criteria

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Prepartum Treatment

Participants receive up to 5 coaching calls over the first 8 weeks after enrolling, with financial incentives for completion and biochemically-verified smoking abstinence at 9 weeks post-enrollment

9 weeks

Remote assessments via smartphone

Postpartum Treatment

Participants are incentivized for completing a postpartum coaching call by 8 weeks postpartum

8 weeks

Remote assessments via smartphone

Follow-up

Participants are monitored for biochemically-verified smoking abstinence at 12 weeks post-enrollment and 12 weeks postpartum

12 weeks

Treatment Details

Interventions

• Standard Care + Financial Incentives

Trial Overview The study tests if small financial rewards can help pregnant women quit smoking. It compares standard care from the Oklahoma Tobacco Helpline with an added incentive program that gives escalating money rewards for attending coaching calls and proving they've stopped smoking.

Participant Groups

Group I: Standard Care + Financial Incentives Experimental Treatment 2 Interventions

Financial Incentives participants will receive standard care plus incentives for completing counseling calls and abstinence.

Group II: Standard Care Active Control 1 Intervention

Participants randomized to Standard Care will be offered weekly counseling calls and pharmacotherapy.

Who Is Running the Clinical Trial?

University of Oklahoma

Lead Sponsor

Trials

484

Recruited

95,900+

References

1. United States pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of financial incentives to low income pregnant women to engage in smoking cessation treatment: Effects on post-birth abstinence. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Financial incentives for smoking cessation in pregnancy: multicentre randomised controlled trial. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Correction for vol. 376, p. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Financial incentives for smoking cessation in pregnancy: protocol for a single arm intervention study. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Financial incentives for smoking cessation in pregnancy: randomised controlled trial. [2022]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Some Recent Developments on Financial Incentives for Smoking Cessation Among Pregnant and Newly Postpartum Women. [2022]

7. England pubmed.ncbi.nlm.nih.gov

An RCT protocol of varying financial incentive amounts for smoking cessation among pregnant women. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Are financial incentives cost-effective to support smoking cessation during pregnancy? [2022]