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Trial record 1 of 1 for:    NCT05019170
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Remote Incentives for Smoking Cessation Among AN Pregnant Women

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ClinicalTrials.gov Identifier: NCT05019170
Recruitment Status : Recruiting
First Posted : August 24, 2021
Last Update Posted : June 13, 2022
Sponsor:
Collaborators:
Alaska Native Tribal Health Consortium
Mayo Clinic
Information provided by (Responsible Party):
Diann Gaalema, University of Vermont

Brief Summary:
Cigarette smoking during pregnancy increases risk for catastrophic pregnancy complications, growth retardation, other adverse infant health problems, and later-in-life chronic conditions. One group that is particularly at risk for these complications are Alaska Native (AN) women. Prevalence of smoking during pregnancy is disproportionally high among AN women compared to US pregnant women overall (i.e., ~36% and ~13%, respectively) and few smoking-cessation interventions have been evaluated among this population. A substantive barrier to offering evidence-based interventions to AN women is the geographic remoteness of Alaska. The most effective intervention for promoting smoking cessation during pregnancy is financial incentives in which participants earn incentives (e.g., cash) contingent on objective evidence of smoking abstinence. This intervention has been adapted to be delivered entirely through a smartphone meaning that the geographic remoteness of Alaska will not be a barrier with this intervention. Participants submit videos of themselves completing breath and saliva tests, and incentives are then delivered through the application if the tests indicate smoking abstinence. Through a collaboration between the University of Vermont and the Alaska Native Tribal Health Consortium, the goal of this study is to examine the preliminary feasibility and efficacy of this smartphone-based incentives intervention among AN women. Pregnant AN women will be recruited through ads posted on social media. Eligible participants who complete the informed consent process will be randomized to either: Best Practices or Best Practices + Incentives. In the Best Practices condition, participants will receive three brief educational sessions and a referral to the Alaska state quitline. In the Best Practices + Incentives condition, participants will receive the same education sessions and quitline referral, plus financial incentives contingent on the smartphone-based testing of breath and saliva specimens indicating abstinence from recent smoking. Outcomes will include point prevalence smoking abstinence at assessments conducted in late pregnancy and 4-, 8-, 12-, and 24-weeks postpartum, continuous abstinence during antepartum and postpartum, and perceived barriers and facilitators of treatment engagement. Overall, this project has the potential to address disparities in access to efficacious, evidence-based smoking cessation treatments among AN pregnant women.

Condition or disease Intervention/treatment Phase
Smoking Smoking Cessation Behavioral: Smartphone-based Financial Incentives Behavioral: Best Practices Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The investigators are proposing a two-condition, parallel groups, randomized controlled pilot study of a smartphone-based financial incentives intervention for AN pregnant smokers. The experimental group will receive financial incentives (money loaded onto a debit card) contingent on the remote submission of breath carbon monoxide and saliva cotinine tests indicating smoking abstinence in addition to best practices for promoting smoking cessation (Best Practices + Incentives). The control group will receive best practices alone (Best Practices). The use of a best practices group reflects a real-world comparison condition in that all women will receive the treatment that practitioners in the community are instructed to provide (the 5As + quitline referral) thereby enhancing the ecological validity of the study. Additionally, the investigators will minimize between-subject variability in the participant's exposure to these practices by implementing these treatment components themselves.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Smartphone-based Financial Incentives to Promote Smoking Cessation Among Alaska Native Pregnant Women
Actual Study Start Date : December 15, 2021
Estimated Primary Completion Date : August 31, 2023
Estimated Study Completion Date : August 31, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Best Practices + Incentives group
Participants assigned to this condition will receive the best practices treatment plus the financial incentives intervention.
Behavioral: Smartphone-based Financial Incentives
Financial Incentives - Beginning on the quit date and extending for one week, participants will be required to submit twice daily CO samples. All samples < 6 ppm will be considered negative and those > 6 ppm will be considered positive. Participants will earn incentives for breath tests indicating smoking abstinence, and incentive values will increase with each consecutive negative sample. Following the initial quit week, the schedule of monitoring will be reduced, and incentives will be contingent on submitting a negative saliva cotinine test.
Other Name: Contingency Management

Behavioral: Best Practices
Best Practices- The 2008 Clinical Practice Guidelines for smoking cessation recommends that pregnant smokers be provided with the 5As. Research staff will implement the 5As at assessments that take place during pregnancy.

Active Comparator: Best Practices
Participants assigned to this condition will receive the best practices treatment alone.
Behavioral: Best Practices
Best Practices- The 2008 Clinical Practice Guidelines for smoking cessation recommends that pregnant smokers be provided with the 5As. Research staff will implement the 5As at assessments that take place during pregnancy.




Primary Outcome Measures :
  1. Late Pregnancy Quit Rate [ Time Frame: 28 weeks gestation through date of delivery ]
    Point prevalence smoking abstinence (defined as a cotinine-negative saliva test AND self-reported no smoking in the past seven days)


Secondary Outcome Measures :
  1. Early Pregnancy Quit Rate [ Time Frame: One month after participant's enrollment date ]
    Point prevalence smoking abstinence (defined as a cotinine negative saliva test AND self-reported no smoking in the past seven days)

  2. 4-Week Postpartum Quit Rate [ Time Frame: 4 weeks following the date that participants deliver their infant ]
    Point prevalence smoking abstinence (defined as a cotinine-negative saliva test AND self-reported no smoking in the past seven days)

  3. 8-Week Postpartum Quit Rate [ Time Frame: 8 weeks following the date that participants deliver their infant ]
    Point prevalence smoking abstinence (defined as a cotinine-negative saliva test AND self-reported no smoking in the past seven days)

  4. 12-Week Postpartum Quit Rate [ Time Frame: 12 weeks following the date that participants deliver their infant ]
    Point prevalence smoking abstinence (defined as a cotinine-negative saliva test AND self-reported no smoking in the past seven days)

  5. 24-Week Postpartum Quit Rate [ Time Frame: 24 weeks following the date that participants deliver their infant ]
    Point prevalence smoking abstinence (defined as a cotinine-negative saliva test AND self-reported no smoking in the past seven days)

  6. Longest Duration of Abstinence (LDA) [ Time Frame: LDA will be measured from participant's date of enrollment in the study to 24-weeks postpartum ]
    Consecutive days of no smoking using biochemical verification (cotinine-negative saliva at the formal assessments) plus self-report (cigarettes per day from enrollment to 24 weeks postpartum reported during timeline follow-back conducted over the phone)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • ≥ 18 years of age
  • report being smokers at the time they learned of the current pregnancy
  • report smoking in the 7 days prior to completing their preliminary eligibility screening
  • < 25 weeks pregnant
  • speak English
  • own a smartphone (Android or iOS)
  • self-report as an Alaska Native
  • current smoker as verified by saliva cotinine test

Exclusion Criteria:

  • current or prior mental or medical condition that may interfere with study participation
  • smoke marijuana more than once each week and not willing to quit (marijuana smoking can inflate breath CO)
  • exposed to unavoidable occupational sources of CO (e.g., car mechanic)
  • report currently receiving opioid maintenance therapy (e.g., methadone, buprenorphine)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05019170


Contacts
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Contact: Tyler G Erath, PhD 336-688-7599 tyler.erath@uvm.edu
Contact: Diann Gaalema, PhD 802-656-9874 Diann.Gaalema@med.uvm.edu

Locations
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United States, Alaska
Alaska Native Tribal Health Consortium Active, not recruiting
Anchorage, Alaska, United States, 99508
United States, Vermont
University of Vermont Recruiting
Burlington, Vermont, United States, 05401
Contact: Tyler G Erath, PhD    336-688-7599    tyler.erath@uvm.edu   
Contact: Diann Gaalema, PhD    802-656-9874    Diann.Gaalema@med.uvm.edu   
Principal Investigator: Diann Gaalema, PhD         
Sponsors and Collaborators
University of Vermont
Alaska Native Tribal Health Consortium
Mayo Clinic
Investigators
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Principal Investigator: Diann Gaalema, PhD University of Vermont
  Study Documents (Full-Text)

Documents provided by Diann Gaalema, University of Vermont:
Informed Consent Form  [PDF] July 29, 2021

Publications:
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Responsible Party: Diann Gaalema, Associate Professor of Psychiatry, University of Vermont
ClinicalTrials.gov Identifier: NCT05019170    
Other Study ID Numbers: 1558083
First Posted: August 24, 2021    Key Record Dates
Last Update Posted: June 13, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No