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临床试验/NCT05429892
NCT05429892进行中(未招募)不适用

FRESH Delivers: An Innovative Approach to Reducing Tobacco Use Among Rural Smokers

University of Arkansas1 个研究点 分布在 1 个国家目标入组 540 人开始时间: 2023年8月9日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
540
试验地点
1
主要终点
Cotinine verified- 7 day point prevalence abstinence

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Care Provider)

盲法说明

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.

入排标准

年龄范围
21 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • Persons who do not meet the above criteria.

研究组 & 干预措施

TRTsocialmot1 arm

Experimental

Smokers will receive real-time video-based motivational counseling and home-based food delivery or grocery store gift card.

Participants will receive educational material.

干预措施: Smoking cessation counseling and food delivery (Behavioral)

TRTmot3 arm

Active Comparator

Smokers will receive real-time video-based motivational counseling only.

Participants will receive educational material.

干预措施: Smoking cessation counseling (Behavioral)

TRTsocial2 arm

Active Comparator

Smokers will receive home-based food delivery only or grocery store gift card.

Participants will receive educational material.

干预措施: Food delivery (Behavioral)

结局指标

主要结局

Cotinine verified- 7 day point prevalence abstinence

时间窗: 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.

次要结局

  • Food security(Changes from baseline food security at 6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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