Adaptation and study protocol of the evidence-based Make Better Choices (MBC2) multiple diet and activity change intervention for a rural Appalachian population.

Adaptation and study protocol of the evidence-based Make Better Choices (MBC2) multiple diet and activity change intervention for a rural Appalachian population.
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DOI:
10.1186/s12889-022-14475-0
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发表时间:
2022-11-08
期刊:
影响因子:
4.5
通讯作者:
--
中科院分区:
医学2区
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--
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阿巴拉契亚农村居民的慢性病患病率最高,过早死亡率最高,预期寿命下降。要解决这些日益严重的不平等现象,同时避免重复现有的方案拟订工作,就必须适当调整循证生活方式干预措施。然而,很少有发表的文章阐述了如何实现这种语境和文化适应。在本文中,我们描述了适应的过程中做出更好的选择2(MBC 2)mHealth饮食和活动随机试验和修订后的协议在农村阿巴拉契亚的干预实施。部署NIH的健康文化框架和Aaron的适应框架,迭代适应过程包括召集焦点小组(N = 4,38名参与者),进行关键信息提供者访谈(N = 16),与我们的社区咨询委员会(N = 9)验证结果,并部署可用性调查(N = 8),线框(N = 8)和试点测试(N = 9)。这一紧张的进程导致全面修订征聘、留用、评估和干预等组成部分。在主要试验中,350名参与者将随机接受多组分MBC 2饮食和活动干预或积极控制条件(压力和睡眠管理)。主要结果是四种行为结果的综合评分:两种结果与饮食有关(增加水果和蔬菜,减少饱和脂肪摄入量),两种与活动有关(增加中等强度体力活动[MVPA],减少久坐活动时间)。次要结局包括生物标志物的变化,包括血压、血脂、A1 C、腰围和BMI。有必要调整和实施循证干预措施,以确保有效的、符合具体情况和文化的卫生服务和方案,特别是针对服务不足和弱势群体的服务和方案。本文描述了一个适应的,社区嵌入式健康干预的发展过程和最终协议,以改善健康行为,并最终推进健康公平。ClinicalTrials.gov标识符NCT 04309461。试验于2020年6月3日登记。在线版本包含补充材料,可通过10.1186/s12889-022-14475-0获得。
Rural Appalachian residents experience among the highest prevalence of chronic disease, premature mortality, and decreased life expectancy in the nation. Addressing these growing inequities while avoiding duplicating existing programming necessitates the development of appropriate adaptations of evidence-based lifestyle interventions. Yet few published articles explicate how to accomplish such contextual and cultural adaptation. In this paper, we describe the process of adapting the Make Better Choices 2 (MBC2) mHealth diet and activity randomized trial and the revised protocol for intervention implementation in rural Appalachia. Deploying the NIH’s Cultural Framework on Health and Aaron’s Adaptation framework, the iterative adaptation process included convening focus groups (N = 4, 38 participants), conducting key informant interviews (N = 16), verifying findings with our Community Advisory Board (N = 9), and deploying usability surveys (N = 8), wireframing (N = 8), and pilot testing (N = 9. This intense process resulted in a comprehensive revision of recruitment, retention, assessment, and intervention components. For the main trial, 350 participants will be randomized to receive either the multicomponent MBC2 diet and activity intervention or an active control condition (stress and sleep management). The main outcome is a composite score of four behavioral outcomes: two outcomes related to diet (increased fruits and vegetables and decreased saturated fat intake) and two related to activity (increased moderate vigorous physical activity [MVPA] and decreased time spent on sedentary activities). Secondary outcomes include change in biomarkers, including blood pressure, lipids, A1C, waist circumference, and BMI. Adaptation and implementation of evidence-based interventions is necessary to ensure efficacious contextually and culturally appropriate health services and programs, particularly for underserved and vulnerable populations. This article describes the development process of an adapted, community-embedded health intervention and the final protocol created to improve health behavior and, ultimately, advance health equity. ClinicalTrials.gov Identifier NCT04309461. The trial was registered on 6/3/2020. The online version contains supplementary material available at 10.1186/s12889-022-14475-0.
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