Clinical trial NCT05429892: FRESH Delivers: an Innovative Approach to Reducing Tobacco Use Among Rural/Black African American Smokers
Official title: FRESH Delivers: an Innovative Approach to Reducing Tobacco Use Among Rural/Black African American Smokers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Tobacco Cessation
Tobacco Dependence
Food Security
Keywords: food security
smoking cessation
Black/African American
social change
motivational counseling
home food delivery
tobacco biomarkers
Lead sponsor: University of Arkansas
Sponsor class: OTHER
First posted: 2022-06-23
Enrollment: 540
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The 3-arm trial (180 smokers per arm) will enroll 540 smokers in Chicot, Desha, Lee, and Phillips and deliver the intervention over 6 months. The study is powered to examine our primary outcome, cotinine-verified 7-day point prevalence abstinence, after 6 months and we will conduct a 12-month follow-up survey. The secondary outcome will be food security. 180 smokers aged 21-75 will be randomized to each condition.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Cotinine verified- 7 day point prevalence abstinence
timeFrame: Changes from baseline cigarette prevalence at 6 months
Secondary outcomes:
measure: Food security
timeFrame: Changes from baseline food security at 6 months
Other outcomes:
measure: Abuse liability - nicotine dependence
timeFrame: Changes from baseline nicotine dependence at 6 months
measure: Abuse liability - discrimination
timeFrame: Changes from baseline discrimination at 6 months
measure: Abuse liability - carbon monoxide
timeFrame: Changes from baseline carbon monoxide at 6 months
measure: Abuse liability - cotinine
timeFrame: Changes from baseline cotinine at 6 months
measure: Abuse liability - trans-3'-hydroxycotinine
timeFrame: Changes from baseline trans-3'-hydroxycotinine at 6 months
measure: Abuse liability - cravings
timeFrame: Changes from baseline cravings at 6 months
measure: Abuse liability - withdrawal
timeFrame: Changes from baseline withdrawal at 6 months
measure: Abuse liability - acrolein
timeFrame: Changes from baseline acrolein at 6 months
measure: Abuse liability - benzaldehyde
timeFrame: Changes from baseline benzaldehyde at 6 months
measure: Abuse liability - formaldehyde
timeFrame: Changes from baseline formaldehyde at 6 months
measure: Recruitment and retention- reach
timeFrame: Monthly until study completion, on average 1 year.
measure: Recruitment and retention-dose delivered
timeFrame: Monthly until study completion, on average 1 year.
measure: Recruitment and retention-dose received
timeFrame: At 6 months.
measure: Recruitment and retention- successful referral
timeFrame: Monthly until study completion, on average 1 year.
Locations:
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
Study officials:
affiliation: University of Arkansas
name: Pebbles Fagan, PhD
role: PRINCIPAL_INVESTIGATOR
References: