Smartphone-based Incentives Intervention to Increase Smoking Cessation During Pregnancy
Examining a Digital Perinatal Smoking-Cessation Intervention
Cigarette smoking is the leading preventable cause of poor pregnancy outcomes in the U.S. and a problem for which more effective and easy-to-access treatments are much needed. This study examines whether outcomes achieved with recommended clinical practices (referral to state tobacco Quitline with follow-up and further referrals for those continuing to smoke) can be improved by also offering financial incentives delivered through a smartphone for maternal smoking abstinence.
Study Overview
Status
Intervention / Treatment
Detailed Description
Pregnant women residing in the U.S. who currently smoke cigarettes and are interested in quitting will be recruited nationally and randomly assigned to what is considered clinical best practices (BP) (referral to state tobacco Quitline with follow-up and further referrals for those continuing to smoke) or best practices in combination with financial incentives (BP+FI). Women assigned to the BP+FI treatment will have opportunities to earn financial incentives by abstaining from smoking during pregnancy and for 3 months after delivering their baby (total possible incentives is $750.00). Women will demonstrate that they have abstained by taking brief salivary cotinine tests using a smartphone or equivalent device. Incentives for abstaining are electronically added to a study-provided debit card. Participation and all results are strictly confidential. Participants in both treatment conditions will be financially compensated for study participation with potential earnings of $525.00. Total potential earnings for those assigned to BP is $525.00 and for those assigned to BP+FI it is $1,275 ($525 for study participation and $750 in incentives for quitting smoking).
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Stephen T Higgins, PhD
- Phone Number: 802-656-9615
- Email: stephen.higgins@uvm.edu
Study Contact Backup
- Name: Katya A Nolder, PhD
- Phone Number: 802-656-9615
- Email: katya.nolder@uvm.edu
Study Locations
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Vermont
-
Burlington, Vermont, United States, 05464
- University of Vermont
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 18 yrs of age
- Reports current pregnancy of </= 25 weeks gestational age
- Consents to allow us to confirm pregnancy with healthcare provider
- Reports current smoking when learned of current pregnancy
- Reports smoking in the 7 days prior to screening
- Reports of smoking in past 7 days is confirmed by a salivary cotinine test
- Owns a digital phone or tablet
- Sufficiently fluent in English to complete study tasks
Exclusion Criteria:
- Reports current or prior mental or medical condition that may interfere with study participation
- Reports current opioid agonist treatment for opioid use disorder
- Current use of prescribed opioid, antipsychotic, or stimulant medications
- Live with someone who is enrolled in the study
- Reside in a group home
- Currently participating in another study that provides financial incentives
- Legal problems that may result in incarceration within the next year
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Best Practices
Best Practices (BP) entails the 5As including referral to the state tobacco Quitline and further referral for those continuing to smoke. |
Participants receive the 5As including a staff referral to the state tobacco quitline. |
|
Experimental: Best Practices plus Financial Incentives
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. |
Participants receive the 5As including a staff referral to the state tobacco quitline. Participants receive financial incentives contingent on biochemically verified abstinence. Incentives are in the form of vouchers exchangeable for retail items and available through 12-weeks postpartum. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Antepartum smoking abstinence
Time Frame: Antepartum period is from study entry through infant delivery which is typically about 24 weeks duration.
|
The primary outcome is whether women randomly assigned to the two treatment groups differ in the percentage who abstain from smoking across an early (< 25 weeks gestation) and late (> 25 weeks gestation) antepartum assessments defined by the percentage of participants assigned to each condition who report no smoking in the past 7 days and submit of a salivary cotinine sample that tests negative for recent smoking. |
Antepartum period is from study entry through infant delivery which is typically about 24 weeks duration.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postpartum smoking abstinence
Time Frame: 2-weeks, 6-weeks, 12-weeks following delivery.
|
Smoking abstinence at 2, 6, and 12 weeks postpartum defined as the percent of participants randomly assigned to each of the two treatment conditions who report no smoking in the past 7 days and submit of a salivary cotinine test sample that is negative for recent smoking. |
2-weeks, 6-weeks, 12-weeks following delivery.
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Birth Outcomes
Time Frame: Birth record at time of delivery
|
Birth outcomes calculated from data extracted from the birth delivery reports include mean birth weight, % low birth weight deliveries (< 2500 g), mean gestational age at delivery, % premature deliveries (< 37 weeks), incidence of Neonatal Intensive Care Unit (NICU) admissions, and mean length of stay per NICU admission. |
Birth record at time of delivery
|
|
Treatment Acceptability Questionnaire
Time Frame: 24 weeks following delivery
|
Participants in both treatment conditions will complete the Treatment Acceptance Questionnaire (TAQ) at the 24-weeks postpartum assessment. The TAQ will query participants about the (1) ease of use of their assigned intervention; (2) helpfulness, and (3) convenience of the intervention; (4) whether the intervention facilitated engagement with smoking-cessation treatment; (5) whether the intervention was fair, (6) fun, (7) or helpful in abstaining from smoking during pregnancy, (8) after the baby was born, and (9) longer-term; and (10) whether they would recommend the treatment that they received to others. All responses will be made using a 100-point visual analogue scale with higher scores represent greater acceptance. |
24 weeks following delivery
|
|
Smoking abstinence at 24-weeks postpartum
Time Frame: 24 weeks after delivery
|
Participants report no smoking in the past 7 days that is confirmed with a negative salivary cotinine test |
24 weeks after delivery
|
|
Cost effectiveness
Time Frame: 24-weeks postpartum
|
A cost-effectiveness analysis of adding financial incentives to the Best-Practices intervention will be conducted. |
24-weeks postpartum
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Stephen T Higgins, PhD, University of Vermont
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00004146
- UG3DA065232 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Investigators are willing to share data once the study is completed and results are published in a peer-reviewed journal. Sharing is conditional on those requesting having a scientific rationale for their request.
IPD Sharing Time Frame
Upon study completion and publication of the primary trial outcomes in a peer-reviewed journal and planned secondary outcomes (e.g., birth outcomes, cost-effectiveness). Anticipated start date is 3 years after trial completion. Anticipated end date is 5 years after study completion.
IPD Sharing Access Criteria
Briefly, this trial will use the standard processing and documentation protocols adopted by the Inter-university Consortium for Political and Social Research (ICPSR). All shared data, metadata, and associated documentation will be deposited via the National Addiction & HIV Data Archive Program (NAHDAP), which is hosted by ICPSR. The scientific data provided by our trial will be findable via a study digital object identifier (DOI) minted by ICPSR. Users of our shared scientific data must register with ICPSR and agree to the Terms of Use, which allows use only for scientific research purposes and aggregate statistical analyses. This is intended to protect research participants and prohibit attempts to identify individual participants. Users must also agree to not redistribute data downloads.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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