An Intervention to Promote Smoking Cessation Among Adults With Food Insecurity
Development of A Navigation Pilot Intervention to Address the Double Burden of Food Insecurity and Tobacco Use in the Clinical Setting
1 other identifier
interventional
55
1 country
1
Brief Summary
This is a two-arm randomized controlled study with 60 participants. The study has two aims. The first aim is to determine the feasibility and acceptability of a food assistance intervention to alleviate food insecurity during a smoking cessation attempt among low-income smokers with food insecurity. Smokers with recent food insecurity are recruited for a 12-week study that involves resources navigation for food assistance and tobacco cessation, with assessments at baseline and at 12 weeks. Participants are randomized to receive economic assistance for food in addition to resources navigation in the intervention arm, or randomized to receive resources navigation only in the control arm. The second aim is to estimate the preliminary impact of the intervention on food insecurity and tobacco cessation measures at 12 weeks.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 10, 2022
CompletedFirst Submitted
Initial submission to the registry
February 18, 2022
CompletedFirst Posted
Study publicly available on registry
March 2, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 23, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
April 23, 2023
CompletedResults Posted
Study results publicly available
July 5, 2024
CompletedJuly 5, 2024
June 1, 2024
1.2 years
February 18, 2022
June 17, 2024
June 17, 2024
Conditions
Outcome Measures
Primary Outcomes (3)
Number of 24-hour Quit Attempts
In the past 3 months, how many times did you stop using tobacco for 24 hours or more because you were trying to quit smoking?
3 months
Longest Length of Abstinence in Days
In the past 3 months, what was the longest time (in days) you went without using tobacco?
3 months
Level of Food Security
6-item Adult/Household Food Security Survey by the US Dept of Agriculture
3 months
Study Arms (2)
Food Assistance and Cessation Resources Navigation Plus Economic Assistance
EXPERIMENTALFood Assistance and Cessation Resources Navigation
ACTIVE COMPARATORInterventions
The intervention arm involves an initial telephone call with a community health worker (CHW). The content of the call focuses on providing participants with referrals for available food assistance resources in the community and referrals for tobacco cessation services. There are two additional follow-up calls approximately 4 weeks apart, for a total of 3 CHW navigator calls over the 12-week study period. In addition, the intervention arm involves providing participants with economic assistance for food in the form of a reloadable debit card ($83 every 4 weeks for 12 weeks, for a maximum amount of $250).
The comparison arm involves an initial telephone call with a community health worker (CHW). The content of the call focuses on providing participants with referrals for available food assistance resources in the community and referrals for tobacco cessation services. There are two additional follow-up calls approximately 4 weeks apart, for a total of 3 CHW navigator calls over the 12-week study period.
Eligibility Criteria
You may qualify if:
- Aged 21 or older
- Current tobacco smoker, defined as having smoked daily over the past 7 days
- Willing to make a serious quit attempt in the next 30 days ("Yes" to "In the next 30 days, are you willing to try quitting smoking for at least 24 hours?")
- Considered food insecure, based on past 30-day screening using the 2-item Hunger Vital Sign, or by virtue of having visited a food pantry in the past 30 days
- Primary food shopper of household, who does half or more of the household food shopping
- A reliable telephone number and a local mailing address where participant can be reached during the duration of the study
You may not qualify if:
- Aged 20 or younger
- Non-smoker, or did not smoke daily over the past 7 days
- Not interested in quitting at this time, assessed by unwillingness to make a serious quit attempt in the next 30 days ("No" to "In the next 30 days, are you willing to try quitting smoking for at least 24 hours?")
- Did not recently experience food insecurity, based on past 30-day screening using the 2-item Hunger Vital Sign, or has not visited a food pantry in the past 30 days
- Not the primary food shopper of the household (does less than half of the household food shopping)
- Does not have a reliable telephone number and a local mailing address where participant can be reached during the duration of the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Case Western Reserve University
Cleveland, Ohio, 44106, United States
Related Publications (1)
Kim-Mozeleski JE, Castele MC, Nambiar P, Chagin KM, Pike Moore S, Hardy P, Cook K, Sehgal AR. A Randomized Trial to Address Food Insecurity and Promote Smoking Cessation Among Low-Income Adults. J Prim Care Community Health. 2024 Jan-Dec;15:21501319241245275. doi: 10.1177/21501319241245275.
PMID: 38584453DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Jin Kim-Mozeleski
- Organization
- Case Western Reserve University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
February 18, 2022
First Posted
March 2, 2022
Study Start
February 10, 2022
Primary Completion
April 23, 2023
Study Completion
April 23, 2023
Last Updated
July 5, 2024
Results First Posted
July 5, 2024
Record last verified: 2024-06
Data Sharing
- IPD Sharing
- Will not share