Actively Recruiting

Phase Not Applicable
Age: 21Years - 75Years
All Genders
Healthy Volunteers
ID05429892

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

Led by University of Arkansas · Updated on 2025-08-07

540

Participants Needed

1

Research Sites

26 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the effect of combining real-time video-based motivational counseling with home-based food deliveries on helping smokers quit tobacco use. The study aims to determine if this combined social intervention improves 7-day smoking abstinence verified by cotinine levels more than either counseling alone or food delivery alone. This approach is based on evidence that better food security may increase the chances of quitting smoking, especially in low-resource rural counties that struggle with tobacco-related health burdens. Participants are randomly assigned to one of three groups: one group receives both video counseling and food deliveries or grocery gift cards, another group receives only video-based motivational counseling, and the third group receives only food deliveries or grocery gift cards. Counseling sessions are delivered by community health workers in three 30-minute real-time video sessions at months 1, 3, and 6. Food deliveries include healthy meal boxes with preparation instructions to reduce transportation barriers. During the 6-month intervention, participants receive educational materials at 1, 3, and 6 months. Researchers will monitor smoking abstinence verified by cotinine at 6 months, changes in food security, tobacco exposure biomarkers, nicotine dependence, cravings, and withdrawal symptoms. They will also assess recruitment and retention rates. Participants must be adults aged 21 to 75 who currently smoke regularly and live in specific rural counties. The total study duration includes follow-up assessments to evaluate these outcomes.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 21Years - 75Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
  • Interested in quitting smoking
  • Provide written or online informed consent
  • Have a working phone, home address, and email
  • Willing to use a study-provided tablet or phone service
  • Willing to report COVID-19 symptoms as needed for safety during personal visits
Not Eligible

You will not qualify if you...

  • Persons who do not meet the above inclusion criteria

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person or remote) to verify smoking status and eligibility

Treatment

Duration - 6 months

Participants receive real-time video-based motivational counseling and/or home-based food delivery to support smoking cessation and improve food security, depending on their assigned group.

3 video counseling sessions and food deliveries or gift cards at months 1, 3, and 6

Follow-up

Duration - Up to 6 months after treatment start

Participants are monitored for smoking abstinence and food security changes after completing the treatment.

Assessments at 6 months to verify smoking status and food security

Trial Site Locations

Total: 1 location

1

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States, 72205

Actively Recruiting

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Research Team

P

Pebbles Fagan, PhD, MPH

S

Sandilyn Bullock, MPH

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

3

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