Family-Based Financial Incentives Intervention for Smoking Cessation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

1312 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-03

Study Completion Date

2028-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The current study will conduct an RCT to evaluate the effectiveness of a family-based incentive intervention with Alaska Native/American Indian families. The experimental arm will be compared to a control arm on biochemically-confirmed smoking abstinence at 6- and 12-months post-intervention.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Alaska Native Family-Based, Financial Incentives Intervention for Smoking Cessation

NCT05413265

Smoking Cessation

COMPLETED NA

Tobacco Cessation Treatment for Pregnant Alaska Natives

NCT00379444

Tobacco Use

COMPLETED PHASE1/PHASE2

Connecting Alaska Native People to Quit Smoking

NCT03645941

Tobacco Use Tobacco Smoking Tobacco Use Cessation +4 more

COMPLETED NA

Remote Incentives for Smoking Cessation Among AN Pregnant Women

NCT05019170

Smoking Smoking Cessation

TERMINATED NA

Biomarker Feedback to Motivate Tobacco Cessation in Pregnant Alaska Native Women

NCT01605643

Cancer Tobacco Use Pregnancy

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Dyads will be stratified by the index participant's sex, and residence with family member, and by the family member's current smoking status then randomized to a no incentives control condition (n=328 dyads) or a 6-month incentive intervention (n=328 dyads).

All dyads will receive existing evidence-based cessation materials on treatment resources and social support strategies. The study will measure the index participant's smoking status in both study groups weekly during the first four weeks, and at three and six months. All participants, including support persons, will receive incentives when they complete each of the smoking status assessments. The intervention group will additionally receive individual rewards provided to the index participant for achieving verified smoking abstinence at each time point, to a maximum of $750.

The enrolled family member will also receive rewards equivalent to the value earned by the index participant that can contribute to family needs. The study will explore potential moderators (e.g., family member smoking status, index participant's sex) and mediators (e.g., interdependence) of intervention effects.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Smoking Cessation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Rewards Group

Index participants in the Rewards Group will be scheduled to complete smoking status check-ins six times during the 6-month Treatment Phase: weekly for four weeks, then at three and six months. At each check-in, cigarette smoking abstinence will be assessed. Participants in the Rewards Group will receive informational materials on smoking cessation.

Group Type EXPERIMENTAL

Financial Incentive Rewards

Intervention Type BEHAVIORAL

Participants in the Rewards Group will have abstinence reinforced through escalating financial incentives.

Comparison Group

Index participants in the Comparison Group will be scheduled to complete smoking status check-ins six times during the 6-month Treatment Phase: weekly for four weeks, then at three and six months. At each check-in, cigarette smoking abstinence will be assessed. Participants in the Comparison Group will receive informational materials on smoking cessation.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Financial Incentive Rewards

Participants in the Rewards Group will have abstinence reinforced through escalating financial incentives.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Alaska Native/American Indian (ANAI) person (based on self-reported race) and reside in Alaska.
* Age ≥18 years.
* Self-report smoking in the past 7 days, biochemically verified with saliva cotinine ≥ 30 ng/mL (positive result based on at-home saliva swab test provided by study team).
* Smoked ≥ 3 cigarettes per day over the past 3 months.
* Considering or willing to make a quit attempt.
* Have or will nominate one adult family member to enroll with them.
* Own or have access to a mobile phone or tablet with Internet and text messaging capabilities, or will be loaned an iPad for the study duration
* Willing to upload photos of self during completion of smoking status tests.
* Willing to complete and sign an Internal Revenue Service (IRS) W-9 tax identification form if they wish to receive payments on the study.
* Willing to provide written informed consent and participate in study-related tests and procedures.

* Age ≥18 years.
* Defined as family and nominated by the index participant, or have an ANAI family member who is ≥18 years and smokes that they would like to support in quitting.
* Own or have access to a mobile phone or tablet with Internet and text messaging capabilities, or will be loaned an iPad for the study duration.
* Willing to complete and sign an IRS W-9 tax identification form if they wish to receive payments on the study.
* Willing to provide written informed consent and participate in study related tests and procedures.

Both men and women, those from non-ANAI racial/ethnic groups, and those who live outside of Alaska in the United States will be eligible family member participants.

Exclusion Criteria

* Already enrolled in the study with another family member.
* Participated in a prior study phase.

* Already enrolled with another family member.
* Participated in a prior study phase.

After the randomized controlled trial, qualitative interviews will be conducted with index participants, family member participants, and Alaska Tribal Health System Stakeholders to inform program implementation. Healthcare providers, cessation specialists, Elder advisors, and Tribal Health System leaders and stakeholders will be invited by the Alaska Native Tribal Health Consortium team and separately consented and interviewed.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No