Ignite Creation Date:
2025-12-24 @ 3:24 PM
Ignite Modification Date:
2026-01-01 @ 10:02 PM
Study NCT ID:
NCT05429892
Status:
RECRUITING
Last Update Posted:
2025-08-07
First Post:
2022-05-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
FRESH Delivers: An Innovative Approach to Reducing Tobacco Use Among Rural Smokers
Sponsor:
University of Arkansas
Organization:
Study Overview
Official Title:
FRESH Delivers: An Innovative Approach to Reducing Tobacco Use Among Rural Smokers
Status:
RECRUITING
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 burdens. 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 chronic disease burdens, resulting in repeated failures to reach smokers 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 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 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 and encourage Americans to participate in interventions that meets a basic need, food security, thus improving social conditions, increasing smoking cessation, and potentially eliminating the risk for cancer health burdens.
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 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 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 and encourage Americans to participate in interventions that meets a basic need, food security, thus improving social conditions, increasing smoking cessation, and potentially eliminating the risk for cancer health burdens.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: