Food Security, Tobacco Cessation, Tobacco Dependence
Conditions
Keywords
food security, smoking cessation, social change, motivational counseling, home food delivery, tobacco biomarkers
Brief summary
The long-term goal of FRESH Delivers is to fill a critical gap in knowledge on the role of a home-based food delivery social intervention in the elimination of tobacco-caused cancer health burdens. The central hypothesis is that smokers who receive real-time video-based motivational counseling and home-based food deliveries will have greater cotinine-verified 7-day point prevalence abstinence than those who receive real-time video-based motivational counseling alone or home food delivery alone. The rationale for this approach is that studies show increased odds of smoking cessation with increasing food security.
Detailed description
The central hypothesis is that smokers who receive real-time video-based motivational counseling and home-based food deliveries will have greater cotinine-verified 7-day point prevalence abstinence than those who receive real-time video-based motivational counseling alone or home food delivery alone. The rationale for this approach is that studies show increased odds of smoking cessation with increasing food security. Prior studies have largely ignored intervening on social conditions that perpetuate chronic disease burdens, resulting in repeated failures to reach smokers in low-resource counties with effective interventions that help them quit smoking. A limited number of interventions that aimed to increase food security also resulted in increased fruit and vegetable consumption and decreased body mass index. But, none have examined the effects of providing food security as a means to help smokers quit. The aims are: Aim 1. Test the efficacy of a social change intervention (home food delivery) on smoking abstinence using a 3-arm randomized controlled design. H1.1: Smokers who receive real-time video-based motivational counseling and home-based food delivery will have greater cotinine-verified 7-day point prevalence abstinence than smokers who receive real-time video-based motivational counseling alone or home food delivery alone. Aim 2. Examine changes in measures of cigarette abuse liability across treatment groups. H2.1: Smokers in the real-time video-based motivational counseling and home-based food delivery intervention will have: 1) fewer signs of nicotine dependence, cravings, and withdrawal and lower levels of biomarkers of tobacco exposure (carbon monoxide, cotinine, trans-3'-hydroxycotinine) and tobacco harm (acrolein, acetaldehyde, benzaldehyde, and formaldehyde) than smokers who receive real-time video-based motivational counseling alone or home food delivery alone. H2.2: Smokers with higher social stressors will show greater signs of nicotine dependence, cravings, and withdrawal and higher levels of biomarkers of tobacco exposure and harm. Aim 3. Examine the extent to which a home food delivery intervention improves recruitment and retention of smokers in the treatment condition. H3.1: Smokers in the real-time video-based motivational counseling and home-based food delivery intervention will have greater reach, dose, and successful referrals compared to smokers who receive motivational counseling alone or home food delivery alone. Impact. The novel home-based food delivery with real-time video-based motivational counseling intervention could increase access to cessation interventions in rural counties where interventions are lacking and encourage Americans to participate in interventions that meets a basic need, food security, thus improving social conditions, increasing smoking cessation, and potentially eliminating the risk for cancer health burdens.
Interventions
BEHAVIORALSmoking cessation counseling and food delivery
The community health workers will delivery three 30-minute sessions during intervention months 1 through 6 (1,3,6 months) to provide interpersonal level support for smoking cessation. The community health workers will conduct real-time video motivational counseling to clients. The community health workers will implement the 5As (Ask, Advise, Assess, Assist, Arrange) and support smokers in quitting, if ready, and build confidence toward quitting if they are uncertain about change. Smokers enrolled in the TRTsocialmot1 arm will be provided with food boxes or grocery store gift card at 1,3, and 6 months. Healthy meal preparation instructions will be included and delivery by project staff and will reduce transportation barriers to food access rural counties. Participants will receive educational materials at 1, 3, and 6 months.
BEHAVIORALSmoking cessation counseling
The community health workers will deliver three 30-minute sessions during intervention months 1 through 6 (1,3,6 months) to provide interpersonal level support for smoking cessation. The community health workers will conduct real-time video motivational counseling to clients. The community health workers will implement the 5As (Ask, Advise, Assess, Assist, Arrange) and support smokers in quitting, if ready, and build confidence toward quitting if they are uncertain about change. Participants will receive educational materials at 1, 3, and 6 months.
BEHAVIORALFood delivery
Smokers enrolled in the TRTsocial2 arm will be provided with food boxes or grocery store gift card at 1, 3, and 6 months Healthy meal preparation instructions will be included and delivery by project staff and will reduce transportation barriers to food access rural counties. Participants will receive educational materials.
Sponsors
University of Arkansas
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)
Masking description
The community health workers who will deliver the intervention will not have access to the randomization information. The participants will also not have access to the information the randomization information.
Intervention model description
The 3-arm trial (180 smokers per arm) will enroll 540 smokers in Chicot, Desha, Lee, and Phillips and deliver the intervention over 6 months. The study is powered to examine our primary outcome, cotinine-verified 7-day point prevalence abstinence, after 6 months and we will conduct a 12-month follow-up survey. The secondary outcome will be food security. 180 smokers aged 21-75 will be randomized to each condition.
Eligibility
Sex/Gender
ALL
Age
21 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Currently smoke regularly for at least 1 year with a verified carbon monoxide level of 5 ppm or greater * Live in Desha, Phillips, Chicot, or Lee Counties * Aged 21 to 75 * Speak English * Interest in quitting * Provide written/online informed consent * Working phone, home address, and email * Willingness to use a study provided tablet/phone service * Willingness to report COVID-19 symptoms as appropriate to assure everyone's safety during a personal visit.
Exclusion criteria
• Persons who do not meet the above criteria.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cotinine verified- 7 day point prevalence abstinence | Changes from baseline cigarette prevalence at 6 months | The study is powered to examine changes in our primary outcome, cotinine-verified 7-day point prevalence abstinence using survey data and collecting a saliva sample. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Food security | Changes from baseline food security at 6 months | The secondary outcome will be food security measured using the US household food security 6-item survey. Scores of 0-1= high to marginal food security; 2-4= low food security; 5-6= very low food security. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORPebbles Fagan, PhD
University of Arkansas
Outcome results
None listed