Incentives for Participation Versus Outcomes

Not Applicable

Withdrawn

• Conditions: Smoking
• Interventions: Behavioral: Incentives for Cessation; Behavioral: Incentives for Participation

• Registration Number: NCT01826331
• Lead Sponsor: University of Rhode Island

Brief Summary

One of the most important debates in the field of disease prevention is whether financial incentives should be contingent on participation in evidence-based programs for smoking cessation or on actual outcomes, like prolonged abstinence. This study can fill a major knowledge gap in this debate, which is the lack of any population trial that compared the impacts of outcomes- and participation-based incentives in a population of smokers. This research can help policy makers and health service providers choose the incentives approach that provides the most effectiveness, cost-effectiveness and cost-savings for entire populations of smokers.

Detailed Description

This population-based randomized clinical trial is designed to compare long-term abstinence rates in three groups of smokers: 1. Those incentivized for participation in an evidence-based treatment designed for smokers at each stage of change; 2. Those incentivized for biologically validated prolonged abstinence at 6 and 12 months who could also choose to participate in the TTM (Transtheoretical Model)-tailored intervention; and 3. An assessment only control condition.

The Specific Aims are:

1. To assess whether the treatment group incentivized for participation outperforms the control group at 12, 24 and 36 months as hypothesized;

2. To assess whether the treatment group incentivized for prolonged abstinence at 6 and 12 months outperforms the control group at each follow-up as hypothesized;

3. To assess whether the treatment group incentivized for participation outperforms the treatment group incentivized for outcomes at 36 months as hypothesized.

4. To compare the cost-effectiveness of each treatment in a population of mostly unmotivated smokers;

The Secondary Aims are:

1. To assess the long-term treatment trajectories of each treatment compared to controls with hypothesized increasing trajectory in the participation contingent incentives and decreasing trajectory in the outcome contingent incentives.

2. To identify mediators of long-term outcomes in each treatment, such as amount of treatment participation, income, severity of smoking, stage of change, self-efficacy, perceived health and intrinsic and extrinsic motivation to quit.

3. To compare cost-savings of each treatment by modeling all additional costs of smoking for employers and smokers.

Study Timeline

• Study First Submitted: 2013-04-03
• Study First Submitted QC: 2013-04-05
• Study First Posted: 2013-04-08
• Study Start: 2014-03
• Primary Completion: 2019-05
• Study Completion: 2019-05
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-14
• Last Update Posted: 2025-04-17

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: 880

Inclusion Criteria

• smoker

Exclusion Criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Incentives for Cessation	Incentives for Cessation	Participants will be incentivized for each assessment and biochemically confirmed abstinence at 12 and 24 months
Incentives for Participation	Incentives for Participation	Participants will be incentivized for each assessment and for each smoking cessation session they complete

Primary Outcome Measures

Name	Time	Method
Smoking abstinence	24 months

Trial Locations

Locations (1)

University of Rhode Island; 🇺🇸 Kingston, Rhode Island, United States