Incentivized Smoking Cessation for Diabetics

Not Applicable

Completed

• Conditions: Smoking Cessation; Diabetes Mellitus, Type 2
• Interventions: Behavioral: Financial incentives

• Registration Number: NCT03527667
• Lead Sponsor: University of Oklahoma

Brief Summary

This pilot study aims to test the feasibility of providing incentives to patients with T2D contingent on remote biochemical verification using a smartphone carbon monoxide (CO) monitor. The investigators will use an ecological momentary assessment (EMA) smartphone application and CO sensor to monitor urges to smoke, stressors, smoking behaviors, and to validate continuous abstinence throughout the intervention. Two different contingency management structures will be explored to investigate the length of time incentives need to be offered.

Detailed Description

Individuals with type 2 diabetes (T2D) are at an increased risk of many cancers, though the causal link is not well understood. Continuing to smoke after a T2D diagnosis is also associated with accelerated progression of microvascular and macrovascular complications and an increased risk of death. Smoking cessation is recommended as a standard treatment for diabetes. However, both patients and providers are faced with other challenging lifestyle changes and disease management processes, which lead to greater difficulty in quitting.

Contingency management, or a method of providing financial incentives contingent upon positive behaviors, has shown promise for improving adherence to medication among diabetics and for improving smoking cessation in other populations. This approach could offer an innovative and scalable means of increasing abstinence in this group, ultimately reducing their risk of cancer. This is a multicenter pilot randomized controlled trial that will recruit participants in Oklahoma and in Strathclyde, Scotland.

This pilot study aims to test the feasibility of providing incentives to patients with T2D contingent on remote biochemical verification using a smartphone carbon monoxide (CO) monitor. The investigators will use an ecological momentary assessment (EMA) smartphone application and CO sensor to monitor urges to smoke, stressors, smoking behaviors, and to validate continuous abstinence throughout the intervention. Two different contingency management structures will be explored to investigate the length of time incentives need to be offered. Qualitative semi-structured interviews will be used to explore the patient and provider acceptability of an incentive-based cessation program, any unintended consequences and possible differences between UK and US health settings.

The results of this research will inform the feasibility of carrying out a randomized controlled trial of this intervention. The ultimate aim is to develop an effective intervention that could be scaled to the T2D population at large, which reduces cancer risk and improves disease outcomes among a high-risk group.

Study Timeline

• Study First Submitted: 2018-05-04
• Study First Submitted QC: 2018-05-04
• Study First Posted: 2018-05-17
• Study Start: 2018-06-22
• Primary Completion: 2019-06-30
• Study Completion: 2019-06-30
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-04
• Last Update Posted: 2019-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

Inclusion Criteria

• Aged 18 to 75
• Type 2 diabetes diagnosis greater than 1 year prior to enrollment
• Currently smoking at least 5 cigarettes per day
• Self-reported quit attempt in past 12 months

Exclusion Criteria

• Unwilling to make a quit attempt
• Unable to use smartphone iCO monitor following training session

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Short term incentives	Financial incentives	usual quit smoking treatment (counseling + medication) plus 6-weeks of payments for proof of smoking abstinence
Long term incentives	Financial incentives	usual quit smoking treatment (counseling + medication) plus 12-weeks of payments for proof of smoking abstinence

Primary Outcome Measures

Name	Time	Method
Proportion of CO readings completed	12 weeks	Feasibility of study determined by number of CO readings completed by each participant

Secondary Outcome Measures

Name	Time	Method
Cigarettes per day	12 weeks	Reduction in cigarettes smoked per day
Quit outcomes	12 weeks	Proportion of participants who quit smoking

Trial Locations

Locations (2)

University of Oklahoma Health Sciences Center; 🇺🇸 Oklahoma City, Oklahoma, United States

University of Strathclyde; 🇬🇧 Glasgow, Scotland, United Kingdom