Tobacco Dependence Clinical Trial
Official title:
FRESH Delivers: An Innovative Approach to Reducing Tobacco Use Among Rural/Black African American Smokers
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.
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. |
Country | Name | City | State |
---|---|---|---|
United States | University of Arkansas for Medical Sciences | Little Rock | Arkansas |
Lead Sponsor | Collaborator |
---|---|
University of Arkansas |
United States,
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 |
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