FRESH Delivers: An Innovative Approach to Reducing Tobacco Use Among Rural Smokers

NCT05429892 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 540

Last updated 2026-07-01

No results posted yet for this study

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.

Conditions

  • Tobacco Cessation
  • Tobacco Dependence
  • Food Security

Interventions

BEHAVIORAL

Smoking cessation counseling and food delivery

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.

BEHAVIORAL

Smoking cessation counseling

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.

BEHAVIORAL

Food delivery

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.

Sponsors & Collaborators

  • University of Arkansas

    lead OTHER

Principal Investigators

  • Pebbles Fagan, PhD · University of Arkansas

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-08-09
Primary Completion
2027-03-30
Completion
2027-03-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05429892 on ClinicalTrials.gov