Clinical trial NCT05259852: An Intervention to Promote Smoking Cessation Among Adults With Food Insecurity
Official title: Development of A Navigation Pilot Intervention to Address the Double Burden of Food Insecurity and Tobacco Use in the Clinical Setting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Food Insecurity
Lead sponsor: Case Western Reserve University
Sponsor class: OTHER
First posted: 2022-03-02
Enrollment: 55
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of 24-hour Quit Attempts
timeFrame: 3 months
measure: Longest Length of Abstinence in Days
timeFrame: 3 months
measure: Level of Food Security
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Case Western Reserve University
state: Ohio
Study officials:
References: