Partnering With Food Bank to Provide Tobacco Treatment to Underserved Smokers

July 9, 2026 updated by: H. Lee Moffitt Cancer Center and Research Institute

Partnering With a State Food Bank to Provide Tobacco Treatment to Underserved Smokers (Project NOURISH)

This study will evaluate the efficacy and economic impact of a theoretically-based, fully automated, interactive smartphone-based smoking cessation intervention.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

502

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Tampa, Florida, United States, 33612
        • Moffitt Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • ≥100 lifetime cigarettes
  • English or Spanish speaking
  • Currently smoke ≥5 cigarettes/day
  • Process a smartphone compatible with the project app
  • Have a valid email address
  • Receipt of food assistance in the past 3 month

Exclusion Criteria:

  • Currently pregnant or breastfeeding
  • Current use of smoking cessation medications
  • Enrolled in a smoking cessation study
  • Household member enrolled in the study
  • Failure to electronically confirm participation with 14 days of randomization via electronic link sent to participant's smartphone

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard Treatment
Participants randomized to Standard Treatment (ST) will be provided with a 10-week supply of nicotine patches and lozenges. ST participants will be connected with Florida Quitline services and will complete weekly 4-item smartphone assessments electronically for 26 weeks. The weekly assessments consist of questions on smoking status, motivation, self-efficacy, and perceived stress.
Drug: Nicotine patch
Participants will be provided with a 10-week supply of nicotine patches
Drug: Nicotine lozenge
Participants will be provided with a 10-week supply of nicotine lozenges
Behavioral: Counseling
Smoking cessation treatment delivery by State Quitline's
Experimental: Automated Treatment
Participants randomized to Automated Treatment (AT) will be given a 10-week supply of nicotine patches and lozenges. AT will also comprise of: 1) 12 proactive treatment videos, delivered weekly, that are tailored on smoking status, motivation, agency, and negative affect/stress; 2) 26 weeks of on-demand access to treatment content that is tailored on smoking status, motivation, agency, and negative affect/stress; 3) 26 weeks of text content.
Drug: Nicotine patch
Participants will be provided with a 10-week supply of nicotine patches
Drug: Nicotine lozenge
Participants will be provided with a 10-week supply of nicotine lozenges
Behavioral: Smartphone-delivered automated treatment
An interactive smartphone-based intervention that comprises content delivered via audio/video clips and text content automatically each week for 12 weeks and on demand for 26 weeks to participants

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self-Reported 7-Day Point-Prevalence Smoking Abstinence
Time Frame: 12 Month Follow-Up
Participants who report no smoking, not even a puff, within the past 7 days
12 Month Follow-Up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Biochemical Verification Via Salivary Cotinine
Time Frame: 12 Month Follow-Up
Investigators will biochemically verify smoking status by collecting cotinine samples via salivary cotinine kit
12 Month Follow-Up
Self-Reported 24-Hour Point-Prevalence Smoking Abstinence
Time Frame: 12 Month Follow-Up
Number of participants who report no smoking, not even a puff, within the past 24 hours
12 Month Follow-Up
Self-Reported 30-Day Point-Prevalence Smoking Abstinence
Time Frame: 12 Month Follow-Up
Number of participants who report no smoking, not even a puff, within the past 30 days
12 Month Follow-Up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Damon J Vidrine, Dr.PH, Moffitt Cancer Center
  • Principal Investigator: Jennifer I Vidrine, Ph.D., Moffitt Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2021

Primary Completion (Actual)

June 5, 2025

Study Completion (Actual)

August 19, 2025

Study Registration Dates

First Submitted

August 6, 2021

First Submitted That Met QC Criteria

August 6, 2021

First Posted (Actual)

August 13, 2021

Study Record Updates

Last Update Posted (Actual)

August 4, 2026

Last Update Submitted That Met QC Criteria

July 9, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MCC-20154
  • R01CA231952 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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