Efficacy of a Smoke-Free Homes Intervention

NCT04547686 | Completed DMC

• 3 other identifiers: STUDY00001085R01CA2357212025P013504
• Study Type: interventional
• Target: 918
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to test whether the integration of a smoke-free homes intervention into the clinical guidelines for tobacco cessation can encourage sustained smoking cessation in low-income primary care patients. The intervention consists of five components, three interactive mailings and two coaching calls, focused on creating home and vehicle(s) smoking bans among smokers.

Conditions

Cessation, Smoking

Keywords

Smoke-Free; Home Intervention; Cessation

Outcome Measures

Primary Outcomes (1)

• Number of participants achieving smoking cessation/abstinence

  Smoking cessation/abstinence is assessed as cotinine-validated 7-day point-prevalence abstinence at 12 months. Saliva samples will be collected via mail from participants who report 7-day (and/or 30-day) point-prevalence abstinence at six- and 12-month follow-up in order to examine cotinine levels to verify self-reported abstinence. A standard cut point of 15 ng/ml is used to determine abstinence.

  12 months

Secondary Outcomes (6)

• Number of participants self-reporting 30-day abstinence

  6 months, 12 months

• Number of cigarettes smoked per day on smoking days

  6 months,12 months

• Number of quit attempts

  6 months, 12 months

• Number of participants with smoke-free home rules

  6 months, 12 months

• Number of participants smoke-free vehicle rules

  6 months, 12 months

Study Arms (2)

Smoke-Free Homes Intervention

EXPERIMENTAL

Participants in the intervention condition will receive the expanded Smoke-Free Homes intervention coupled with a connection to the quitline. Follow-up will be at six and twelve months, including saliva cotinine validation for reported 7-day cessation.

Behavioral: Smoke-Free Homes Intervention; Behavioral: Control

Control

ACTIVE COMPARATOR

The usual care/control arm will receive mailed information on the quitline and a connection to the quitline at their request. Follow-up will be at six and twelve months, including saliva cotinine validation for reported 7-day cessation.

Behavioral: Control

Interventions

Smoke-Free Homes Intervention BEHAVIORAL

The adapted smoke-free homes intervention consists of five components, three interactive mailings and two coaching calls, focused on creating home and vehicle(s) smoking bans among smokers. The intervention is based on principles of Social Cognitive Theory and the Transtheoretical Model's stages of change. The rationale underlying the intervention is that creation of additional smoke-free environments will reduce situational and environmental cues to smoke, reduce opportunities and places to smoke, increase self-efficacy for quitting and increase motivation to quit. The intervention uses persuasion, role modeling, behavioral contracting and goal setting to move smokers through behavioral capability, outcome expectations and self-efficacy for strict smoke-free rules, creation of and compliance/enforcement with smoke-free rules, reduced cigarettes smoked per day, increased motivation to quit, increased quit attempts, and successful cessation.

Smoke-Free Homes Intervention

Control BEHAVIORAL

The quitline is a phone number that people can call that offers free smoking cessation counseling to all Georgia residents by the state of Georgia.

Control; Smoke-Free Homes Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age and older
• referred by primary care physician or provider of a participating Federally Qualified Health Center (FQHC) in Georgia
• have smoked at least one cigarette in the past 30 days
• has ability to speak and understand English
• be the only patient per household to be enrolled in the study
• not currently be enrolled in a cessation program

You may not qualify if:

• non-smoker
• unable to speak or understand English
• under 18 years of age
• have another family or household member participating in the research
• vulnerable special populations will not be enrolled, including:
• adults unable to consent
• pregnant women
• prisoners
• cognitively impaired or Individuals with Impaired Decision-Making Capacity
• not able to clearly understand English
• community participation

Sponsors & Collaborators

• Emory University: lead
• National Institutes of Health (NIH): collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Rollins School of Public Health, Emory University

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Study Officials

• Michelle Kegler, DrPH

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 8, 2020
• First Posted: September 14, 2020
• Study Start: November 11, 2020
• Primary Completion: July 27, 2025
• Study Completion: July 27, 2025
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: The time frame for making data available for sharing is to be determined.
• Access Criteria: Access will be granted to investigators who submit a request to the PI for any analyses that are not planned by the research team (with a description of the research question, desired variables, analysis plan, and dissemination plan).

Locations

US (1)