Evaluating the Feasibility and Efficacy of a Real-time Smoking Intervention Using Wearable Technology

Not Applicable

Completed

• Conditions: Tobacco Use Cessation
• Interventions: Behavioral: Real-Time Smoking Intervention; Behavioral: Standard Treatment

• Registration Number: NCT04172623
• Lead Sponsor: Yale University

Brief Summary

This study will use wearable technology to test the feasibility and efficacy of delivering a novel real-time smoking intervention to improve standard tobacco treatment.

Detailed Description

The goals of this project include evaluating the feasibility, acceptability, and helpfulness of the real-time smoking intervention and to assess the preliminary efficacy of the real-time intervention as an adjunct to standard tobacco treatment. Rates of adherence, participant satisfaction, and perceived usefulness will be evaluated through post-treatment interviews and ratings. Biochemically confirmed 7-day point prevalence abstinence will be compared between the experimental and control groups at the end of treatment (week 8).

Study Timeline

• Study Start: 2019-06-01
• Study First Submitted: 2019-07-08
• Study First Submitted QC: 2019-11-20
• Study First Posted: 2019-11-21
• Primary Completion: 2022-01-31
• Study Completion: 2022-01-31
• Results First Submitted: 2022-04-25
• Results First Submitted QC: 2022-04-25
• Results First Posted: 2023-01-26
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-09
• Last Update Posted: 2023-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

Inclusion Criteria

• 18 or older
• Able to read English
• Cigarette smoker
• Seeking smoking cessation treatment

Read More

Exclusion Criteria

• Serious psychiatric or medical condition
• Unable or unwilling to complete study protocol

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Real-Time Smoking Intervention	Real-Time Smoking Intervention	Adult smokers will use wearable technology in order to receive real-time feedback as a smoking intervention in addition to standard treatment.
Standard Treatment	Standard Treatment	Adult smokers will receive standard outpatient tobacco treatment.
Real-Time Smoking Intervention	Standard Treatment	Adult smokers will use wearable technology in order to receive real-time feedback as a smoking intervention in addition to standard treatment.

Primary Outcome Measures

Name	Time	Method
Change in Cigarettes	Baseline and Week 8	Self-reported cigarette use (Timeline follow-back data) during the 8-week study to estimate effect sizes between groups.

Secondary Outcome Measures

Name	Time	Method
% Days Abstinent From Cigarettes	Week 8	Timeline follow-back data will be collected to determine the % of days abstinent from cigarettes.

Trial Locations

Locations (1)

Yale University; 🇺🇸 New Haven, Connecticut, United States