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

Part of paid clinical trials in Little Rock, Arkansas.

Sponsor
University of Arkansas
Study ID
NCT05429892
Status
Recruiting
Apply to this trial

Conditions

  • Food Security
  • Tobacco Cessation
  • Tobacco Dependence

Eligibility Criteria

Sex
ALL
Age
21 Years - 75 Years
Healthy Volunteers
Accepted

Interventions

  • Smoking cessation counseling and food delivery — BEHAVIORAL
    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 counseling — BEHAVIORAL
    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 delivery — BEHAVIORAL
    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 Details

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.

Key Dates

Start date
Aug 9, 2023
Status verified
Aug 2025
Primary completion
Mar 30, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
540 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: TRTsocialmot1 arm
    Smokers will receive real-time video-based motivational counseling and home-based food delivery or grocery store gift card. Participants will receive educational material.
  • Active Comparator: TRTmot3 arm
    Smokers will receive real-time video-based motivational counseling only. Participants will receive educational material.
  • Active Comparator: TRTsocial2 arm
    Smokers will receive home-based food delivery only or grocery store gift card. Participants will receive educational material.

Primary Outcome Measure

Cotinine verified- 7 day point prevalence abstinence [ Time Frame: Changes from baseline cigarette prevalence at 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Arkansas for Medical SciencesLittle RockArkansas72205
Pebbles Fagan, PhD, MPH
[email protected]
501-526-2294
Sandilyn Bullock, MPH
[email protected]
501-526-6039

Find similar trials in Little Rock, AR

By research site
University of Arkansas for Medical Sciences· Little Rock, AR

Related Studies