Multiphase optimization strategy to establish optimal delivery of nutrition-related services in healthcare settings: A step towards clinical trial

IF 2 3区 医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL Contemporary clinical trials Pub Date : 2024-09-03 DOI:10.1016/j.cct.2024.107683
Jennifer L. Lemacks , Tammy Greer , Sermin Aras , Shantoni Holbrook , June Gipson
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Abstract

Background

Minorities living in the Southern US generally have greater incidence and prevalence of cardiometabolic diseases compared to other groups. Cardiometabolic disease prevalence and risk can be reduced by focusing on diet and lifestyle modifications. There is need for holistic and integrated care models for community-based healthcare organizations who are already working with minorities. This research aimed to select and optimize essential psychosocial and structural components to address diet behaviors among racial/ethnic minorities, and/or disadvantaged background young to middle aged adult populations in Mississippi.

Methods

Nutrition360 was guided by a community-academic team using a participatory approach and included a preparation and two optimization phases to examine different approaches to dietary interventions utilizing the multiphase optimization strategy. Each intervention arm included three different modalities to identify the most feasible delivery method. The intervention was conducted at a community-based, outpatient healthcare center located in Jackson, MS. Eligible participants were between 25 and 50 years old, residents of Jackson metropolitan area, at risk for cardiovascular disease-related premature mortality, and had internet access. Individuals who completed baseline surveys were randomly assigned to an intervention group and then to modality order. Co-primary outcomes were research participant burden and cost-effectiveness and secondary outcomes were attendance, and dietary measures.

Results

Thirty-one, African American individuals with a mean age of 40.5 years completed baseline surveys and were randomized to an intervention program.

Conclusion

The two most feasible and cost-effective interventions will be combined to further test this model's delivery in the real-world setting as part of the next optimization phase.

Registration

ClinicalTrials.gov, NCT06286618. https://clinicaltrials.gov/study/NCT06286618

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制定多阶段优化战略,优化医疗机构的营养相关服务:迈向临床试验的一步。
背景:与其他群体相比,生活在美国南部的少数族裔通常有更高的心脏代谢疾病发病率和患病率。通过注重饮食和生活方式的调整,可以降低心脏代谢疾病的发病率和风险。对于已经在为少数族裔提供服务的社区医疗保健机构来说,需要整体和综合的护理模式。这项研究旨在选择和优化基本的社会心理和结构组成部分,以解决密西西比州少数种族和/或弱势背景的中青年成年人的饮食行为问题:Nutrition360 由一个社区-学术团队指导,采用参与式方法,包括一个准备阶段和两个优化阶段,利用多阶段优化策略研究饮食干预的不同方法。每个干预臂包括三种不同的模式,以确定最可行的实施方法。干预在位于密歇根州杰克逊市的一家社区门诊医疗中心进行。符合条件的参与者年龄在 25 岁至 50 岁之间,是杰克逊大都会地区的居民,有心血管疾病相关的过早死亡风险,并能上网。完成基线调查的人被随机分配到干预组,然后再按方式顺序排列。共同主要结果是研究参与者的负担和成本效益,次要结果是出勤率和饮食措施:31名平均年龄为40.5岁的非洲裔美国人完成了基线调查,并被随机分配到干预计划中:结论:作为下一个优化阶段的一部分,将把两种最可行、最具成本效益的干预措施结合起来,进一步测试该模式在现实世界环境中的实施情况:注册:ClinicalTrials.gov,NCT06286618。https://clinicaltrials.gov/study/NCT06286618。
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来源期刊
CiteScore
3.70
自引率
4.50%
发文量
281
审稿时长
44 days
期刊介绍: Contemporary Clinical Trials is an international peer reviewed journal that publishes manuscripts pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from disciplines including medicine, biostatistics, epidemiology, computer science, management science, behavioural science, pharmaceutical science, and bioethics. Full-length papers and short communications not exceeding 1,500 words, as well as systemic reviews of clinical trials and methodologies will be published. Perspectives/commentaries on current issues and the impact of clinical trials on the practice of medicine and health policy are also welcome.
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