FRESH Delivers: An Innovative Approach to Reducing Tobacco Use Among Rural/Black African American Smokers

Not Applicable

Recruiting

• Conditions: Tobacco Cessation; Tobacco Dependence; Food Security

• Registration Number: NCT05429892
• Lead Sponsor: University of Arkansas

Brief Summary

The long-term goal of FRESH Delivers is to fill a critical gap in knowledge on the role of a home-based food delivery social intervention in the elimination of tobacco-caused cancer health disparities. The central hypothesis is that smokers who receive real-time video-based motivational counseling and home-based food deliveries will have greater cotinine-verified 7-day point prevalence abstinence than those who receive real-time video-based motivational counseling alone or home food delivery alone. The rationale for this approach is that studies show increased odds of smoking cessation with increasing food security.

Detailed Description

The central hypothesis is that smokers who receive real-time video-based motivational counseling and home-based food deliveries will have greater cotinine-verified 7-day point prevalence abstinence than those who receive real-time video-based motivational counseling alone or home food delivery alone. The rationale for this approach is that studies show increased odds of smoking cessation with increasing food security. Prior studies have largely ignored intervening on social conditions that perpetuate disparities, resulting in repeated failures to reach African Americans in low-resource counties with effective interventions that help them quit smoking. A limited number of interventions that aimed to increase food security also resulted in increased fruit and vegetable consumption and decreased body mass index. But, none have examined the effects of providing food security as a means to help smokers quit. The aims are:

Aim 1. Test the efficacy of a social change intervention (home food delivery) on smoking abstinence using a 3-arm randomized controlled design. H1.1: Smokers who receive real-time video-based motivational counseling and home-based food delivery will have greater cotinine-verified 7-day point prevalence abstinence than smokers who receive real-time video-based motivational counseling alone or home food delivery alone.

Aim 2. Examine changes in measures of cigarette abuse liability across treatment groups. H2.1: Smokers in the real-time video-based motivational counseling and home-based food delivery intervention will have: 1) fewer signs of nicotine dependence, cravings, and withdrawal and lower levels of biomarkers of tobacco exposure (carbon monoxide, cotinine, trans-3'-hydroxycotinine) and tobacco harm (acrolein, acetaldehyde, benzaldehyde, and formaldehyde) than smokers who receive real-time video-based motivational counseling alone or home food delivery alone. H2.2: Smokers with higher social stressors (every day discrimination, major experiences of discrimination, discriminatory health care experiences) will show greater signs of nicotine dependence, cravings, and withdrawal and higher levels of biomarkers of tobacco exposure and harm.

Aim 3. Examine the extent to which a home food delivery intervention improves recruitment and retention of Black/African American smokers in the treatment condition. H3.1: Smokers in the real-time video-based motivational counseling and home-based food delivery intervention will have greater reach, dose, and successful referrals compared to smokers who receive motivational counseling alone or home food delivery alone.

Impact. The novel home-based food delivery with real-time video-based motivational counseling intervention could increase access to cessation interventions in rural counties where interventions are lacking, create equity in the reach of interventions to groups who face persistent structural racism and discrimination, and encourage a diverse clientele of Blacks/African Americans to participate in interventions that meet a basic need, food security, thus improving social conditions, increasing smoking cessation, and potentially eliminating the risk for cancer health disparities.

Study Timeline

• Study First Submitted: 2022-05-23
• Study First Submitted QC: 2022-06-20
• Study First Posted: 2022-06-23
• Study Start: 2023-08-09
• Status Verified: 2024-08
• Last Update Submitted: 2025-01-02
• Last Update Posted: 2025-01-06
• Primary Completion: 2025-08-30
• Study Completion: 2026-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 540

Inclusion Criteria

• Currently smoke regularly for at least 1 year with a verified carbon monoxide level of 5 ppm or greater
• Live in Desha, Phillips, Chicot, or Lee Counties
• Aged 21 to 75
• Speak English
• Interest in quitting
• Provide written/online informed consent
• Working phone, home address, and email
• Willingness to use a study provided tablet/phone service
• Willingness to report COVID-19 symptoms as appropriate to assure everyone's safety during a personal visit.

Exclusion Criteria

• Persons who do not meet the above criteria.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Cotinine verified- 7 day point prevalence abstinence	Changes from baseline cigarette prevalence at 6 months	The study is powered to examine changes in our primary outcome, cotinine-verified 7-day point prevalence abstinence using survey data and collecting a saliva sample.

Secondary Outcome Measures

Name	Time	Method
Food security	Changes from baseline food security at 6 months	The secondary outcome will be food security measured using the US household food security 6-item survey. Scores of 0-1= high to marginal food security; 2-4= low food security; 5-6= very low food security.

Trial Locations

Locations (1)

University of Arkansas for Medical Sciences; 🇺🇸 Little Rock, Arkansas, United States