search
Back to results

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

Primary Purpose

Tobacco Cessation, Tobacco Dependence, Food Security

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Smoking cessation counseling and food delivery
Smoking cessation counseling
Food delivery
Sponsored by
University of Arkansas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Tobacco Cessation focused on measuring food security, smoking cessation, Black/African American, social change, motivational counseling, home food delivery, tobacco biomarkers

Eligibility Criteria

21 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of Arkansas for Medical SciencesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

TRTsocialmot1 arm

TRTmot3 arm

TRTsocial2 arm

Arm Description

Smokers will receive real-time video-based motivational counseling and home-based food delivery. Participants will receive educational material.

Smokers will receive real-time video-based motivational counseling only. Participants will receive educational material.

Smokers will receive home-based food delivery only. Participants will receive educational material.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
May 23, 2022
Last Updated
October 5, 2023
Sponsor
University of Arkansas
search

1. Study Identification

Unique Protocol Identification Number
NCT05429892
Brief Title
FRESH Delivers: An Innovative Approach to Reducing Tobacco Use Among Rural/Black African American Smokers
Official Title
FRESH Delivers: An Innovative Approach to Reducing Tobacco Use Among Rural/Black African American Smokers
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 9, 2023 (Actual)
Primary Completion Date
August 2025 (Anticipated)
Study Completion Date
September 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Arkansas

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tobacco Cessation, Tobacco Dependence, Food Security
Keywords
food security, smoking cessation, Black/African American, social change, motivational counseling, home food delivery, tobacco biomarkers

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantCare Provider
Masking Description
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.
Allocation
Randomized
Enrollment
540 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TRTsocialmot1 arm
Arm Type
Experimental
Arm Description
Smokers will receive real-time video-based motivational counseling and home-based food delivery. Participants will receive educational material.
Arm Title
TRTmot3 arm
Arm Type
Active Comparator
Arm Description
Smokers will receive real-time video-based motivational counseling only. Participants will receive educational material.
Arm Title
TRTsocial2 arm
Arm Type
Active Comparator
Arm Description
Smokers will receive home-based food delivery only. Participants will receive educational material.
Intervention Type
Behavioral
Intervention Name(s)
Smoking cessation counseling and food delivery
Other Intervention Name(s)
TRTsocialmot1
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Smoking cessation counseling
Other Intervention Name(s)
TRTmot3 arm
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Food delivery
Other Intervention Name(s)
TRTsocial2
Intervention Description
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.
Primary Outcome Measure Information:
Title
Cotinine verified- 7 day point prevalence abstinence
Description
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.
Time Frame
Changes from baseline cigarette prevalence at 6 months
Secondary Outcome Measure Information:
Title
Food security
Description
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.
Time Frame
Changes from baseline food security at 6 months
Other Pre-specified Outcome Measures:
Title
Abuse liability - nicotine dependence
Description
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.
Time Frame
Changes from baseline nicotine dependence at 6 months
Title
Abuse liability - discrimination
Description
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.
Time Frame
Changes from baseline discrimination at 6 months
Title
Abuse liability - carbon monoxide
Description
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.
Time Frame
Changes from baseline carbon monoxide at 6 months
Title
Abuse liability - cotinine
Description
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.
Time Frame
Changes from baseline cotinine at 6 months
Title
Abuse liability - trans-3'-hydroxycotinine
Description
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.
Time Frame
Changes from baseline trans-3'-hydroxycotinine at 6 months
Title
Abuse liability - cravings
Description
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.
Time Frame
Changes from baseline cravings at 6 months
Title
Abuse liability - withdrawal
Description
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.
Time Frame
Changes from baseline withdrawal at 6 months
Title
Abuse liability - acrolein
Description
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.
Time Frame
Changes from baseline acrolein at 6 months
Title
Abuse liability - benzaldehyde
Description
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.
Time Frame
Changes from baseline benzaldehyde at 6 months
Title
Abuse liability - formaldehyde
Description
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.
Time Frame
Changes from baseline formaldehyde at 6 months
Title
Recruitment and retention- reach
Description
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.
Time Frame
Monthly until study completion, on average 1 year.
Title
Recruitment and retention-dose delivered
Description
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.
Time Frame
Monthly until study completion, on average 1 year.
Title
Recruitment and retention-dose received
Description
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.
Time Frame
At 6 months.
Title
Recruitment and retention- successful referral
Description
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.
Time Frame
Monthly until study completion, on average 1 year.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pebbles Fagan, PhD, MPH
Phone
5015262294
Email
pfagan@uams.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Sandilyn Bullock, MPH
Phone
501-526-6039
Email
SBBullock@uams.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pebbles Fagan, PhD
Organizational Affiliation
University of Arkansas
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pebbles Fagan, PhD, MPH
Phone
501-526-2294
Email
pfagan@uams.edu
First Name & Middle Initial & Last Name & Degree
Sandilyn Bullock, MPH
Phone
501-526-6039
Email
SBBullock@uams.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
We will coordinate these efforts with the NIMHD coordinating center to determine what data will be shared across studies.
IPD Sharing Time Frame
At the end of the study
IPD Sharing Access Criteria
Contact the PI for the protocol and obtain instructions on how to access. Persons must complete registration.

Learn more about this trial

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

We'll reach out to this number within 24 hrs