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

Tobacco Dependence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05429892
• Other study ID #: 273441
• Status: Recruiting
• Phase: N/A
• Start date: August 9, 2023
• Est. completion date: September 30, 2026

Study information

• Verified date: January 2024
• Source: University of Arkansas
• Contact: Pebbles Fagan, PhD, MPH
• Phone: 5015262294
• Email: pfagan[@]uams.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 540
• Est. completion date: September 30, 2026
• Est. primary completion date: August 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Food Security
• Tobacco Cessation
• Tobacco Dependence
• Tobacco Use Disorder

Intervention

Behavioral:
• Smoking cessation counseling and food delivery
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.
• Smoking cessation counseling
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.
• Food delivery
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.

Locations

Country	Name	City	State
United States	University of Arkansas for Medical Sciences	Little Rock	Arkansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Arkansas

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Abuse liability - nicotine dependence	Examine changes in measures of cigarette abuse liability across treatment groups. Abuse liability will be measured using a 6-item nicotine dependence (Fagerstrom Test for Nicotine Dependence) scale on surveys. Scores of 8-10=very high dependence; 6-7= high ; 5= moderate; 3-4= low; 0-2= very low dependence.	Changes from baseline nicotine dependence at 6 months
Other	Abuse liability - discrimination	Examine changes in measures of cigarette abuse liability across treatment groups. Abuse liability will be measured using the 10-item everyday discrimination scale on surveys. Scores range from 10 to 60 with higher scores (1=never to almost 6=everyday) being indicative of more frequent experiences.	Changes from baseline discrimination at 6 months
Other	Abuse liability - carbon monoxide	Examine changes in measures of cigarette abuse liability across treatment groups. Abuse liability will be measured using carbon monoxide measured via the Smokerlyzer® monitors. Higher carbon monoxide scores mean greater exposure to tobacco.	Changes from baseline carbon monoxide at 6 months
Other	Abuse liability - cotinine	Examine changes in measures of cigarette abuse liability across treatment groups. Abuse liability will be measured by collecting saliva that will allow us to assess cotinine levels. Higher cotinine levels mean greater exposure tobacco.	Changes from baseline cotinine at 6 months
Other	Abuse liability - trans-3'-hydroxycotinine	Examine changes in measures of cigarette abuse liability across treatment groups. Abuse liability will be measured by collecting saliva that will allow us to assess - trans-3'-hydroxycotinine levels. Higher levels mean greater exposure to tobacco.	Changes from baseline trans-3'-hydroxycotinine at 6 months
Other	Abuse liability - cravings	Examine changes in measures of cigarette abuse liability across treatment groups. Abuse liability will be measured using the 10-item brief questionnaire of smoking urges. Scores range from 1 (strongly disagree) to 7 (strongly agree) ad result in two factors related to specific items in the scale. The higher the score, the stronger to urge.	Changes from baseline cravings at 6 months
Other	Abuse liability - withdrawal	Examine changes in measures of cigarette abuse liability across treatment groups. Abuse liability will be measured using the 6-item Minnesota withdrawal scale (2021). Scores range from 0=none to 4=severe. The higher the score the more severe the withdrawal.	Changes from baseline withdrawal at 6 months
Other	Abuse liability - acrolein	Examine changes in measures of cigarette abuse liability across treatment groups. Abuse liability will be measured by collecting saliva that will allow us to assess -acrolein levels. Higher levels mean greater exposure to this tobacco toxin.	Changes from baseline acrolein at 6 months
Other	Abuse liability - benzaldehyde	Examine changes in measures of cigarette abuse liability across treatment groups. Abuse liability will be measured by collection saliva that will allow us to assess benzaldehyde levels. Higher levels mean greater exposure to this tobacco toxin.	Changes from baseline benzaldehyde at 6 months
Other	Abuse liability - formaldehyde	Examine changes in measures of cigarette abuse liability across treatment groups. Abuse liability will be measured by collection saliva that will allow us to assess formaldehyde levels. Higher levels mean greater exposure to this tobacco toxin.	Changes from baseline formaldehyde at 6 months
Other	Recruitment and retention- reach	Examine reach to participants. Reach will be assessed by calculating # participants enrolled in the study each month. Staff will review completed consent forms and baseline surveys monthly.	Monthly until study completion, on average 1 year.
Other	Recruitment and retention-dose delivered	Examine dose of the intervention delivered to participants. Dose delivered will be assessed by calculating the number of intervention activities delivered (motivational counseling, food delivery). Staff will complete a process tracking form after the delivery of each intervention activity.	Monthly until study completion, on average 1 year.
Other	Recruitment and retention-dose received	Examine dose of the intervention received by participants. Dose received will be assessed by calculating the participant report of number of interventions received (motivational counseling, food delivery). Participants will be asked about the interventions received on the 6-month survey.	At 6 months.
Other	Recruitment and retention- successful referral	Examine successful referral of participants to the study. Staff will document the number of persons who enrolled in the study who were referred by an enrolled study participant.	Monthly until study completion, on average 1 year.
Primary	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	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