Tobacco CessationNCT05415371
Persistent Poverty Counties Pregnant Women With Medicaid
A study of Tobacco Cessation and Tobacco Use, run by University of Oklahoma at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 105 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Tobacco Cessation, Tobacco Use, Tobacco Smoking
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2022to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 105 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- participants will be excluded if they do not meet the inclusion criteria
Trial locations and contacts
1 site in 1 country.
United States1 site
TSET Health Promotion Research Center
Oklahoma City, Oklahoma, 73104
About this study
Official title: Monetary Incentives to Promote Engagement With the Oklahoma Tobacco Helpline Among Pregnant Women With Medicaid
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.
- Conditions
- Tobacco Cessation, Tobacco Use, Tobacco Smoking, Smoking Cessation Financial Incentives, Socioeconomic Status, Contingency Management
- Being tested
- Standard Care + Financial Incentives, Standard Care
- Medical subject headings
- Tobacco Use Cessation, Tobacco Use, Tobacco Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Care + Financial IncentivesBehavioural
Financial incentive participants will receive standard care and receive incentives for completing counseling calls and for abstinence.
Standard CareOther
Participants randomized to Standard Care will be offered weekly counseling calls and pharmacotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Standard Care | Active comparator | Participants randomized to Standard Care will be offered weekly counseling calls and pharmacotherapy. Receives: Other: Standard Care |
| Standard Care + Financial Incentives | Experimental | Financial Incentives participants will receive standard care plus incentives for completing counseling calls and abstinence. Receives: Behavioral: Standard Care + Financial Incentives; Other: Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biochemically verified abstinence 12 weeks post enrollment
The outcome measure is biochemically verified over 7-day point prevalence at 12 weeks post-enrollment.
Measured: 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
Measured: 12 weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2022
- Study start30 Sep 2022
- Primary completion30 Jun 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco CessationStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05415371
- Sponsor's protocol ID
- 14736
- Status last verified
- Sep 2024
- First submitted
- 25 May 2022
- Last updated
- 2 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monetary Incentives to Promote Engagement With the Oklahoma Tobacco Helpline Among Pregnant Women With Medicaid
- ClinicalTrials.gov ID
- NCT05415371
- Acronym / sponsor ID
- 14736
- Conditions
- Tobacco Cessation, Tobacco Use, Tobacco Smoking, Smoking Cessation Financial Incentives, Socioeconomic Status, Contingency Management
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Study start
- 30 Sep 2022 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 13 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Care | Active comparator | Other: Standard CareParticipants randomized to Standard Care will be offered weekly counseling calls and pharmacotherapy. |
| Standard Care + Financial Incentives | Experimental | Behavioral: Standard Care + Financial Incentives, Other: Standard CareFinancial Incentives participants will receive standard care plus incentives for completing counseling calls and abstinence. |
Who may qualify
- Ages
- 18 to 105 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- participants will be excluded if they do not meet the inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard Care + Financial IncentivesFinancial incentive participants will receive standard care and receive incentives for completing counseling calls and for abstinence. | Behavioural | Standard Care + Financial Incentives |
| Standard CareParticipants randomized to Standard Care will be offered weekly counseling calls and pharmacotherapy. | Other | Standard Care, Standard Care + Financial Incentives |
Primary outcome
Biochemically verified abstinence 12 weeks post enrollment
Time frame: 12 weeks post enrollment
The outcome measure is biochemically verified over 7-day point prevalence at 12 weeks post-enrollment.
Self-reported abstinence 12 weeks postpartum
Time frame: 12 weeks postpartum
The outcome measure is biochemically verified abstinence over 7-day point prevalence at 12 weeks post-partum
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Tobacco Cessation and Tobacco Use, run by University of Oklahoma at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biochemically verified abstinence 12 weeks post enrollment (time frame: 12 weeks post enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2024.