Smoking CessationNCT05259852
An Intervention to Promote Smoking Cessation Among Adults With Food Insecurity
A study testing Food Assistance and Cessation Resources Navigation Plus Economic Assistance and Food Assistance and Cessation Resources Navigation in people with Smoking Cessation and Food Insecurity, run by Case Western Reserve University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Smoking Cessation, Food Insecurity
- What is being tested?
- Food Assistance and Cessation Resources Navigation Plus Economic Assistance and Food Assistance and Cessation Resources Navigation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Feb 2022to 23 Apr 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Case Western Reserve University
Cleveland, Ohio, 44106
About this study
Official title: Development of A Navigation Pilot Intervention to Address the Double Burden of Food Insecurity and Tobacco Use in the Clinical Setting
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.
Read the detailed description
Tobacco use remains a leading cause of preventable disease, disability, and early death. National-level data show that the majority of smokers are interested in quitting and attempt to quit each year, but there are socioeconomic disparities in successfully quitting. In particular, smoking cessation can be especially hard when smokers are dealing with unmet social and health needs and areas of financial stress, which are disproportionately experienced by low-income smokers. This study extends previous research showing that food insecurity is independently associated with higher odds of smoking and can act as a barrier to quitting smoking. The study's main research question is whether alleviating food insecurity specifically during a smoking cessation attempt is helpful for increasing quitting success rates. Therefore, the study is testing a 12-week intervention to assist food-insecure smokers who are ready and willing to make a quit attempt. Beyond providing the quit assistance that smokers normally receive through healthcare providers, the research seeks to address food insecurity in the short-term by providing economic assistance for food during the quit attempt that will help to meet food needs. The study will adapt a patient navigation model in which a designated study navigator can help bridge resources and referrals related to tobacco cessation and food access, and provide economic food assistance based on individualized needs. The study will recruit 60 participants for a 12-week study, and all participants will be smokers who are ready to quit and have recently experienced food insecurity. All participants will receive quit assistance and information on local food assistance resources, and a monthly check-in from the navigator. In addition, half of the participants (n=30) will be randomly assigned to the intervention arm, and will receive economic food assistance to alleviate food insecurity during the cessation attempt. The first aim is to assess feasibility and acceptability of the intervention, and the second aim is to estimate preliminary outcomes related to smoking cessation, such as the number of quit attempts lasting 24 hours or more and the longest length of abstinence from tobacco, and reduction in food insecurity during the intervention period. By conducting this study, the investigators seek to understand whether this type of intervention is feasible to conduct, and acceptable to those who participate. The study findings will serve as the basis of future research on understanding and addressing tobacco-related and food insecurity-related health disparities.
- Conditions
- Smoking Cessation, Food Insecurity
- Being tested
- Food Assistance and Cessation Resources Navigation Plus Economic Assistance, Food Assistance and Cessation Resources Navigation
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Food Assistance and Cessation Resources Navigation Plus Economic AssistanceBehavioural
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).
Food Assistance and Cessation Resources NavigationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Food Assistance and Cessation Resources Navigation Plus Economic Assistance | Experimental | Not described Receives: Behavioral: Food Assistance and Cessation Resources Navigation Plus Economic Assistance |
| Food Assistance and Cessation Resources Navigation | Active comparator | Not described Receives: Behavioral: Food Assistance and Cessation Resources Navigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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?
Measured: 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?
Measured: 3 months
Level of Food Security
6-item Adult/Household Food Security Survey by the US Dept of Agriculture
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2022
- Study start10 Feb 2022
- Primary completion23 Apr 2023
- Study completion23 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Western Reserve University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin Kim-Mozeleski, Case Western Reserve University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05259852
- Sponsor's protocol ID
- Kim-MozeleskiStudy20210127
- Status last verified
- Jun 2024
- First submitted
- 18 Feb 2022
- Last updated
- 5 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38584453
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of A Navigation Pilot Intervention to Address the Double Burden of Food Insecurity and Tobacco Use in the Clinical Setting
- ClinicalTrials.gov ID
- NCT05259852
- Acronym / sponsor ID
- Kim-MozeleskiStudy20210127
- Conditions
- Smoking Cessation, Food Insecurity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Case Western Reserve UniversityUniversity, hospital or other
- Study start
- 10 Feb 2022 (actual)
- Primary completion
- 23 Apr 2023 (actual)
- Study completion
- 23 Apr 2023 (actual)
- First posted
- 2 Mar 2022 (actual)
- Results
- Posted 5 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Tobacco use remains a leading cause of preventable disease, disability, and early death. National-level data show that the majority of smokers are interested in quitting and attempt to quit each year, but there are socioeconomic disparities in successfully quitting. In particular, smoking cessation can be especially hard when smokers are dealing with unmet social and health needs and areas of financial stress, which are disproportionately experienced by low-income smokers. This study extends previous research showing that food insecurity is independently associated with higher odds of smoking and can act as a barrier to quitting smoking. The study's main research question is whether alleviating food insecurity specifically during a smoking cessation attempt is helpful for increasing quitting success rates. Therefore, the study is testing a 12-week intervention to assist food-insecure smokers who are ready and willing to make a quit attempt. Beyond providing the quit assistance that smokers normally receive through healthcare providers, the research seeks to address food insecurity in the short-term by providing economic assistance for food during the quit attempt that will help to meet food needs. The study will adapt a patient navigation model in which a designated study navigator can help bridge resources and referrals related to tobacco cessation and food access, and provide economic food assistance based on individualized needs. The study will recruit 60 participants for a 12-week study, and all participants will be smokers who are ready to quit and have recently experienced food insecurity. All participants will receive quit assistance and information on local food assistance resources, and a monthly check-in from the navigator. In addition, half of the participants (n=30) will be randomly assigned to the intervention arm, and will receive economic food assistance to alleviate food insecurity during the cessation attempt. The first aim is to assess feasibility and acceptability of the intervention, and the second aim is to estimate preliminary outcomes related to smoking cessation, such as the number of quit attempts lasting 24 hours or more and the longest length of abstinence from tobacco, and reduction in food insecurity during the intervention period. By conducting this study, the investigators seek to understand whether this type of intervention is feasible to conduct, and acceptable to those who participate. The study findings will serve as the basis of future research on understanding and addressing tobacco-related and food insecurity-related health disparities.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Food Assistance and Cessation Resources Navigation Plus Economic Assistance | Experimental | Behavioral: Food Assistance and Cessation Resources Navigation Plus Economic Assistance |
| Food Assistance and Cessation Resources Navigation | Active comparator | Behavioral: Food Assistance and Cessation Resources Navigation |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Food Assistance and Cessation Resources Navigation Plus Economic AssistanceThe 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). | Behavioural | Food Assistance and Cessation Resources Navigation Plus Economic Assistance |
| Food Assistance and Cessation Resources NavigationThe 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. | Behavioural | Food Assistance and Cessation Resources Navigation |
Primary outcome
Number of 24-hour Quit Attempts
Time frame: 3 months
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?
Longest Length of Abstinence in Days
Time frame: 3 months
In the past 3 months, what was the longest time (in days) you went without using tobacco?
Level of Food Security
Time frame: 3 months
6-item Adult/Household Food Security Survey by the US Dept of Agriculture
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38584453Kim-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Food Assistance and Cessation Resources Navigation Plus Economic Assistance and Food Assistance and Cessation Resources Navigation in people with Smoking Cessation and Food Insecurity, run by Case Western Reserve University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of 24-hour Quit Attempts (time frame: 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05259852, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2024.