FRESH Delivers: An Innovative Approach to Reducing Tobacco Use Among Rural Smokers
1 other identifier
interventional
540
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2023
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 23, 2022
CompletedFirst Posted
Study publicly available on registry
June 23, 2022
CompletedStudy Start
First participant enrolled
August 9, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2026
ExpectedAugust 7, 2025
August 1, 2025
2.6 years
May 23, 2022
August 1, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Food security
Changes from baseline food security at 6 months
Other Outcomes (13)
Abuse liability - nicotine dependence
Changes from baseline nicotine dependence at 6 months
Abuse liability - carbon monoxide
Changes from baseline carbon monoxide at 6 months
Abuse liability - cotinine
Changes from baseline cotinine at 6 months
- +10 more other outcomes
Study Arms (3)
TRTsocialmot1 arm
EXPERIMENTALSmokers will receive real-time video-based motivational counseling and home-based food delivery or grocery store gift card. Participants will receive educational material.
TRTmot3 arm
ACTIVE COMPARATORSmokers will receive real-time video-based motivational counseling only. Participants will receive educational material.
TRTsocial2 arm
ACTIVE COMPARATORSmokers will receive home-based food delivery only or grocery store gift card. Participants will receive educational material.
Interventions
The community health workers will delivery three 30-minute sessions during intervention months 1 through 6 (1,3,6 months) 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 food boxes or grocery store gift card at 1,3, and 6 months. Healthy meal preparation instructions will be included and delivery by project staff and will reduce transportation barriers to food access rural counties. Participants will receive educational materials at 1, 3, and 6 months.
The community health workers will deliver three 30-minute sessions during intervention months 1 through 6 (1,3,6 months) 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 at 1, 3, and 6 months.
Smokers enrolled in the TRTsocial2 arm will be provided with food boxes or grocery store gift card at 1, 3, and 6 months Healthy meal preparation instructions will be included and delivery by project staff and will reduce transportation barriers to food access rural counties. Participants will receive educational materials.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Persons who do not meet the above criteria.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pebbles Fagan, PhD
University of Arkansas
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Masking Details
- The community health workers who will deliver the intervention will not have access to the randomization information. The participants will also not have access to the information the randomization information.
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 23, 2022
First Posted
June 23, 2022
Study Start
August 9, 2023
Primary Completion
March 30, 2026
Study Completion (Estimated)
September 30, 2026
Last Updated
August 7, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- At the end of the study
- Access Criteria
- Contact the PI for the protocol and obtain instructions on how to access. Persons must complete registration.
We will coordinate these efforts with the NIMHD research coordinating center to determine what data will be shared across studies.