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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Food Assistance and Cessation Resources Navigation Plus Economic Assistance | Experimental |
| |
| Food Assistance and Cessation Resources Navigation | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Food Assistance and Cessation Resources Navigation Plus Economic Assistance | Behavioral | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Case Western Reserve University | Cleveland | Ohio | 44106 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38584453 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Food Assistance and Cessation Resources Navigation Plus Economic Assistance | Food Assistance and Cessation Resources Navigation Plus Economic Assistance: 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). |
| FG001 | Food Assistance and Cessation Resources Navigation | Food Assistance and Cessation Resources Navigation: 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Food Assistance and Cessation Resources Navigation Plus Economic Assistance | Food Assistance and Cessation Resources Navigation Plus Economic Assistance: 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). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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? | Complete case analysis | Posted | Mean | Standard Deviation | number of 24-hour quit attempts | 3 months |
|
Adverse event data were collected throughout the study period, from the beginning to end of data collection.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Food Assistance and Cessation Resources Navigation Plus Economic Assistance | Food Assistance and Cessation Resources Navigation Plus Economic Assistance: 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). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jin Kim-Mozeleski | Case Western Reserve University | 216-368-6793 | jin.kim-mozeleski@case.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 9, 2023 | Jun 17, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D063105 | Food Assistance |
| ID | Term |
|---|---|
| D011632 | Public Assistance |
| D005380 | Financing, Government |
| D005381 | Financing, Organized |
| D004467 | Economics |
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|
| Food Assistance and Cessation Resources Navigation | Behavioral | 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. |
|
| BG001 | Food Assistance and Cessation Resources Navigation | Food Assistance and Cessation Resources Navigation: 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Education | Count of Participants | Participants |
|
| Annual household income | Count of Participants | Participants |
|
| Marital status | Count of Participants | Participants |
|
| OG001 | Food Assistance and Cessation Resources Navigation | Food Assistance and Cessation Resources Navigation: 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. |
|
|
| Primary | Longest Length of Abstinence in Days | In the past 3 months, what was the longest time (in days) you went without using tobacco? | complete case analysis | Posted | Mean | Standard Deviation | days | 3 months |
|
|
|
| Primary | Level of Food Security | 6-item Adult/Household Food Security Survey by the US Dept of Agriculture | complete case analysis | Posted | Count of Participants | Participants | 3 months |
|
|
|
| 0 |
| 28 |
| 0 |
| 28 |
| 0 |
| 28 |
| EG001 | Food Assistance and Cessation Resources Navigation | Food Assistance and Cessation Resources Navigation: 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. | 0 | 27 | 0 | 27 | 0 | 27 |
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| D004472 |
| Health Care Economics and Organizations |
| Very low food security |
|