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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Tobacco Cessation, Tobacco Dependence, Food Security

Intervention / Treatment
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* Behavioral: Smoking cessation counseling and food delivery
* Behavioral: Smoking cessation counseling
* Behavioral: Food delivery


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TRTsocialmot1 arm<br>Smokers will receive real-time video-based motivational counseling and home-based food delivery. Participants will receive educational material. | Behavioral: Smoking cessation counseling and food delivery<br>* The community health workers will delivery five 30-minute sessions during intervention months 1 through 5 to provide interpersonal level support for smoking cessation. The community health workers will conduct real-time video motivational counseling to clients. The community health workers will implement the 5As (Ask, Advise, Assess, Assist, Arrange) and support smokers in quitting, if ready, and build confidence toward quitting if they are uncertain about change. Smokers enrolled in the TRTsocialmot1 arm will be provided with monthly delivery of food boxes in accordance with the number of persons in the household and caloric intake needed to support one week's worth of family meals. Healthy meal preparation instructions will be included and delivery by project staff will reduce transportation barriers to food access rural counties. Participants will receive educational materials.<br>* Other names: TRTsocialmot1;|
| Active Comparator: TRTmot3 arm<br>Smokers will receive real-time video-based motivational counseling only. Participants will receive educational material. | Behavioral: Smoking cessation counseling<br>* The community health workers will delivery five 30-minute sessions during intervention months 1 through 5 to provide interpersonal level support for smoking cessation. The community health workers will conduct real-time video motivational counseling to clients. The community health workers will implement the 5As (Ask, Advise, Assess, Assist, Arrange) and support smokers in quitting, if ready, and build confidence toward quitting if they are uncertain about change. Participants will receive educational materials.<br>* Other names: TRTmot3 arm;|
| Active Comparator: TRTsocial2 arm<br>Smokers will receive home-based food delivery only. Participants will receive educational material. | Behavioral: Food delivery<br>* Smokers enrolled in the TRTsocial2 arm will be provided with monthly delivery of food boxes in accordance with the number of persons in the household and caloric intake needed to support one week's worth of family meals. Healthy meal preparation instructions will be included and delivery by project staff will reduce transportation barriers to food access rural counties. Participants will receive educational materials.<br>* Other names: TRTsocial2;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cotinine verified- 7 day point prevalence abstinence | 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. | Changes from baseline cigarette prevalence at 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Food security | 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. | Changes from baseline food security at 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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food security, smoking cessation, Black/African American, social change, motivational counseling, home food delivery, tobacco biomarkers