NCT05019170

Remote Incentives for Smoking Cessation Among AN Pregnant Women

Terminated NA Last updated 1 December 2023

What this trial tests

NA trial testing Smartphone-based Financial Incentives in Smoking in 5 participants. Terminated before completion.

Timeline

15 December 2021

Primary endpoint
31 August 2023

31 August 2023

Quick facts

Lead sponsor	University of Vermont
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	5
Start date	15 December 2021
Primary completion	31 August 2023
Estimated completion	31 August 2023
Sites	2 locations across United States

Drugs / interventions tested

• Smartphone-based Financial Incentives
• Best Practices

Conditions studied

• Smoking — all drugs for Smoking →
• Smoking Cessation — all drugs for Smoking Cessation →

Sponsor

University of Vermont

Who can join

18 and older, female only, with Smoking or Smoking Cessation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.