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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05259852
Enrollment
55
Registered
2022-03-02
Start date
2022-02-10
Completion date
2023-04-23
Last updated
2024-07-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Food Insecurity, Smoking Cessation

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.

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.

Interventions

BEHAVIORALFood 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).

BEHAVIORALFood 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.

Sponsors

Case Western Reserve University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Number of 24-hour Quit Attempts3 monthsIn 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 Days3 monthsIn the past 3 months, what was the longest time (in days) you went without using tobacco?
Level of Food Security3 months6-item Adult/Household Food Security Survey by the US Dept of Agriculture

Countries

United States

Participant flow

Participants by arm

ArmCount
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).
28
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.
27
Total55

Baseline characteristics

CharacteristicFood Assistance and Cessation Resources Navigation Plus Economic AssistanceFood Assistance and Cessation Resources NavigationTotal
Age, Continuous50.8 years
STANDARD_DEVIATION 15.3
49.9 years
STANDARD_DEVIATION 12.6
50.4 years
STANDARD_DEVIATION 13.9
Annual household income
$10,000 - $19,999
9 Participants10 Participants19 Participants
Annual household income
$20,000 - $39,999
7 Participants9 Participants16 Participants
Annual household income
$40,000 - $59,999
0 Participants2 Participants2 Participants
Annual household income
$60,000 - $79,999
2 Participants0 Participants2 Participants
Annual household income
$80,000 or higher
0 Participants0 Participants0 Participants
Annual household income
Less than $10,000
9 Participants6 Participants15 Participants
Annual household income
Prefer not to answer
1 Participants0 Participants1 Participants
Education
College degree
0 Participants3 Participants3 Participants
Education
Did not complete high school
3 Participants3 Participants6 Participants
Education
High school graduate or GED
9 Participants10 Participants19 Participants
Education
More than a college degree
1 Participants2 Participants3 Participants
Education
Prefer not to answer
0 Participants0 Participants0 Participants
Education
Some college
15 Participants9 Participants24 Participants
Marital status
Divorced or separated
7 Participants7 Participants14 Participants
Marital status
Married or partnered
3 Participants3 Participants6 Participants
Marital status
Prefer not to answer
0 Participants0 Participants0 Participants
Marital status
Single, never married
17 Participants15 Participants32 Participants
Marital status
Widowed
1 Participants2 Participants3 Participants
Race (NIH/OMB)
American Indian or Alaska Native
1 Participants1 Participants2 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
13 Participants11 Participants24 Participants
Race (NIH/OMB)
More than one race
1 Participants2 Participants3 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants1 Participants2 Participants
Race (NIH/OMB)
White
12 Participants12 Participants24 Participants
Region of Enrollment
United States
28 participants27 participants55 participants
Sex: Female, Male
Female
20 Participants20 Participants40 Participants
Sex: Female, Male
Male
8 Participants7 Participants15 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 280 / 27
other
Total, other adverse events
0 / 280 / 27
serious
Total, serious adverse events
0 / 280 / 27

Outcome results

Primary

Level of Food Security

6-item Adult/Household Food Security Survey by the US Dept of Agriculture

Time frame: 3 months

Population: complete case analysis

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Food Assistance and Cessation Resources Navigation Plus Economic AssistanceLevel of Food SecurityHigh/marginal food security4 Participants
Food Assistance and Cessation Resources Navigation Plus Economic AssistanceLevel of Food SecurityLow food security12 Participants
Food Assistance and Cessation Resources Navigation Plus Economic AssistanceLevel of Food SecurityVery low food security9 Participants
Food Assistance and Cessation Resources NavigationLevel of Food SecurityHigh/marginal food security4 Participants
Food Assistance and Cessation Resources NavigationLevel of Food SecurityLow food security7 Participants
Food Assistance and Cessation Resources NavigationLevel of Food SecurityVery low food security8 Participants
Primary

Longest Length of Abstinence in Days

In the past 3 months, what was the longest time (in days) you went without using tobacco?

Time frame: 3 months

Population: complete case analysis

ArmMeasureValue (MEAN)Dispersion
Food Assistance and Cessation Resources Navigation Plus Economic AssistanceLongest Length of Abstinence in Days18.7 daysStandard Deviation 21
Food Assistance and Cessation Resources NavigationLongest Length of Abstinence in Days9.3 daysStandard Deviation 15.5
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?

Time frame: 3 months

Population: Complete case analysis

ArmMeasureValue (MEAN)Dispersion
Food Assistance and Cessation Resources Navigation Plus Economic AssistanceNumber of 24-hour Quit Attempts2.6 number of 24-hour quit attemptsStandard Deviation 1.8
Food Assistance and Cessation Resources NavigationNumber of 24-hour Quit Attempts1.8 number of 24-hour quit attemptsStandard Deviation 1.7

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026