NCT05415371

Brief Summary

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 25, 2022

Completed
19 days until next milestone

First Posted

Study publicly available on registry

June 13, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

September 30, 2022

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

October 2, 2024

Status Verified

September 1, 2024

Enrollment Period

2.8 years

First QC Date

May 25, 2022

Last Update Submit

September 30, 2024

Conditions

Tobacco CessationTobacco UseTobacco SmokingSmoking Cessation Financial IncentivesSocioeconomic StatusContingency ManagementPregnancy

Outcome Measures

Primary Outcomes (2)

  • Biochemically verified abstinence 12 weeks post enrollment

    The outcome measure is biochemically verified over 7-day point prevalence at 12 weeks post-enrollment.

    12 weeks post enrollment

  • Self-reported abstinence 12 weeks postpartum

    The outcome measure is biochemically verified abstinence over 7-day point prevalence at 12 weeks post-partum

    12 weeks postpartum

Study Arms (2)

Standard Care

ACTIVE COMPARATOR

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

Other: Standard Care

Standard Care + Financial Incentives

EXPERIMENTAL

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

Behavioral: Standard Care + Financial IncentivesOther: Standard Care

Interventions

Standard Care + Financial IncentivesBEHAVIORAL

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

Standard Care + Financial Incentives
Standard CareOTHER

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

Standard CareStandard Care + Financial Incentives

Eligibility Criteria

Age18 Years - 105 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • contact the Oklahoma Tobacco Helpline seeking smoking cessation treatment, and enroll in the multiple call program
  • are a female ≤ 25 weeks pregnant
  • report smoking ≥ 5 cigarettes per day
  • are ≥ 18 years of age
  • are able to provide a copy/photo of their ID/driver's license or other documentation of identity
  • are able to read, speak, and understand English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

TSET Health Promotion Research Center

Oklahoma City, Oklahoma, 73104, United States

Location

MeSH Terms

Conditions

Tobacco Use CessationTobacco UseTobacco Smoking

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Health BehaviorBehaviorSmoking

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 25, 2022

First Posted

June 13, 2022

Study Start

September 30, 2022

Primary Completion

June 30, 2025

Study Completion

December 31, 2025

Last Updated

October 2, 2024

Record last verified: 2024-09

Locations

US(1)