Tobacco CessationNCT05429892
FRESH Delivers: An Innovative Approach to Reducing Tobacco Use Among Rural Smokers
A study testing Smoking cessation counseling and food delivery, Smoking cessation counseling and Food delivery in people with Tobacco Cessation and Tobacco Dependence, run by University of Arkansas at 1 site in United States.
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 burdens. Read more about this study
- Who is it for?
- Ages 21 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Tobacco Cessation, Tobacco Dependence, Food Security
- What is being tested?
- Smoking cessation counseling and food delivery, Smoking cessation counseling and Food delivery
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 540 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Aug 2023to 30 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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.
Who cannot join
- Persons who do not meet the above criteria.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
About this study
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.
Read the 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 chronic disease burdens, resulting in repeated failures to reach smokers 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 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 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 and encourage Americans to participate in interventions that meets a basic need, food security, thus improving social conditions, increasing smoking cessation, and potentially eliminating the risk for cancer health burdens.
- Conditions
- Tobacco Cessation, Tobacco Dependence, Food Security
- Being tested
- Smoking cessation counseling and food delivery, Smoking cessation counseling, Food delivery
- Keywords
- food security, smoking cessation, social change, motivational counseling, home food delivery, tobacco biomarkers
- Medical subject headings
- Tobacco Use Cessation, Tobacco Use Disorder, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smoking cessation counseling and food deliveryBehavioural
Also called TRTsocialmot1
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.
Smoking cessation counselingBehavioural
Also called TRTmot3 arm
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.
Food deliveryBehavioural
Also called TRTsocial2
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.
| Study group | Role | What they receive |
|---|---|---|
| TRTsocialmot1 arm | Experimental | Smokers will receive real-time video-based motivational counseling and home-based food delivery or grocery store gift card.
Participants will receive educational material. Receives: Behavioral: Smoking cessation counseling and food delivery |
| TRTmot3 arm | Active comparator | Smokers will receive real-time video-based motivational counseling only.
Participants will receive educational material. Receives: Behavioral: Smoking cessation counseling |
| TRTsocial2 arm | Active comparator | Smokers will receive home-based food delivery only or grocery store gift card.
Participants will receive educational material. Receives: Behavioral: Food delivery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Changes from baseline cigarette prevalence at 6 months
Secondary outcomes (1)
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.
Measured: Changes from baseline food security at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2022
- Study start9 Aug 2023
- Primary completion30 Mar 2027 (estimated)
- Study completion30 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco CessationStudies of the same condition, open and under way.
- More trials run by University of ArkansasThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Care provider
- Enrolment
- 540 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pebbles Fagan, PhD, Principal investigator, University of Arkansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05429892
- Sponsor's protocol ID
- 273441
- Status last verified
- Jun 2026
- First submitted
- 23 May 2022
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will coordinate these efforts with the NIMHD research coordinating center to determine what data will be shared across studies.
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FRESH Delivers: An Innovative Approach to Reducing Tobacco Use Among Rural Smokers
- ClinicalTrials.gov ID
- NCT05429892
- Acronym / sponsor ID
- 273441
- Conditions
- Tobacco Cessation, Tobacco Dependence, Food Security
- Keywords
- food security, smoking cessation, social change, motivational counseling, home food delivery, tobacco biomarkers
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 540 participants (estimated)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Study start
- 9 Aug 2023 (actual)
- Primary completion
- 30 Mar 2027 (estimated)
- Study completion
- 30 Mar 2027 (estimated)
- First posted
- 23 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 chronic disease burdens, resulting in repeated failures to reach smokers 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 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 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 and encourage Americans to participate in interventions that meets a basic need, food security, thus improving social conditions, increasing smoking cessation, and potentially eliminating the risk for cancer health burdens.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| TRTsocialmot1 arm | Experimental | Behavioral: Smoking cessation counseling and food deliverySmokers 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 comparator | Behavioral: Smoking cessation counselingSmokers will receive real-time video-based motivational counseling only. Participants will receive educational material. |
| TRTsocial2 arm | Active comparator | Behavioral: Food deliverySmokers will receive home-based food delivery only or grocery store gift card. Participants will receive educational material. |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (1 listed)
- Persons who do not meet the above criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smoking cessation counseling and food deliveryAlso: TRTsocialmot1The 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. | Behavioural | TRTsocialmot1 arm |
| Smoking cessation counselingAlso: TRTmot3 armThe 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. | Behavioural | TRTmot3 arm |
| Food deliveryAlso: TRTsocial2Smokers 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. | Behavioural | TRTsocial2 arm |
Primary outcome
Cotinine verified- 7 day point prevalence abstinence
Time frame: Changes from baseline cigarette prevalence at 6 months
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.
1 secondary outcome
Food security
Time frame: Changes from baseline food security at 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Individual participant dataSharing planned: Yes. We will coordinate these efforts with the NIMHD research coordinating center to determine what data will be shared across studies.
Related trials for Tobacco Cessation
Not yet recruitingObservational study
PROMETHEE: A Shared Interregional Tele-Tobacco Cessation Platform Embedded Within the IMPULSION Lung Cancer Screening Program
Smoking Cessation, Lung Cancer Screening
Not yet recruiting
Impacto 2.0: Mobile Smoking Cessation Across Texas
Cigarette Smoking, Smoking Cessation
Active, not recruiting
Vaping Cessation Using the Ottawa Model for Smoking Cessation Among E-Cigarette Users
Tobacco Smoking, Vaping
Recruiting
Young Adult Tobacco/Nicotine and Cannabis Co-use
Tobacco Use Disorder, Nicotine Dependence
Recruiting
Social Media Support Groups for Adolescent Vaping Cessation
Vaping, Vaping Cessation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pebbles Fagan, PhD principal investigator
University of Arkansas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smoking cessation counseling and food delivery, Smoking cessation counseling and Food delivery in people with Tobacco Cessation and Tobacco Dependence, run by University of Arkansas at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cotinine verified- 7 day point prevalence abstinence (time frame: Changes from baseline cigarette prevalence at 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026.