Persistent Poverty Counties Pregnant Women With Medicaid

Sponsor

University of Oklahoma (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05415371

Collaborator

(none)

100

Enrollment

Location

Arms

13.9

Anticipated Duration (Months)

7.2

Patients Per Site Per Month

Study Details

Study Description

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 findings of a meta-analysis have concluded that incentivizing smoking cessation is an effective approach among pregnant women. 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 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) In addition, participants will be incentivized for completing up to 2 postpartum coaching calls by 8 weeks postpartum. Feasibility outcomes for the incentives-based intervention will focus on coaching call completion, rates of prepartum and postpartum follow-up, and perceptions of the intervention. Potential effectiveness will be evaluated by comparing self-reported smoking abstinence rates in OTH+I relative to OTH alone at 12 weeks post-enrollment (prepartum) and 12 weeks postpartum.

Condition or Disease	Intervention/Treatment	Phase
Tobacco Cessation Tobacco Use Tobacco Smoking Smoking Cessation Financial Incentives Socioeconomic Status Contingency Management Pregnancy	Behavioral: Standard Care + Financial Incentives Other: Standard Care	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Monetary Incentives to Promote Engagement With the Oklahoma Tobacco Helpline Among Pregnant Women With Medicaid

Anticipated Study Start Date :

Sep 1, 2022

Anticipated Primary Completion Date :

Jul 30, 2023

Anticipated Study Completion Date :

Oct 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Standard Care Participants randomized to Standard Care will be offered weekly counseling calls and pharmacotherapy.	Other: Standard Care Financial incentive participants will receive standard care and for completing counseling calls
Experimental: Standard Care + Financial Incentives Financial Incentives participants will receive standard care plus incentives for completing counseling calls.	Behavioral: Standard Care + Financial Incentives Participants randomized to Standard Care will be offered weekly counseling calls and pharmacotherapy. Other: Standard Care Financial incentive participants will receive standard care and for completing counseling calls

Arm

Intervention/Treatment

Active Comparator: Standard Care

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

Other: Standard Care

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

Experimental: Standard Care + Financial Incentives

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

Behavioral: Standard Care + Financial Incentives

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

Other: Standard Care

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

Outcome Measures

Primary Outcome Measures

Self-reported abstinence 12 weeks post enrollment [12 weeks post enrollment]
The outcome measure is self-reported 7-day point prevalence at 12 weeks post-enrollment.
Self-reported abstinence 12 weeks postpartum [12 weeks postpartum]
The outcome measure is self-reported 7-day point prevalence at 12 weeks post-partum

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 105 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria

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

Exclusion Criteria

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	TSET Health Promotion Research Center	Oklahoma City	Oklahoma	United States	73104

Sponsors and Collaborators

University of Oklahoma

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Oklahoma

ClinicalTrials.gov Identifier:

NCT05415371

Other Study ID Numbers:

14736

First Posted:

Jun 13, 2022

Last Update Posted:

Aug 4, 2022

Last Verified:

Aug 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Aug 4, 2022