Connell Carol L, Thomson Jessica L, Huye Holly F, Landry Alicia S, Crook LaShaundrea B, Yadrick Kathy
Department of Nutrition and Food Systems, The University of Southern Mississippi, 118 College Drive #5172, Hattiesburg, MS 39406, United States.
Agricultural Research Service, United States Department of Agriculture, Stoneville, MS 38776, United States.
Contemp Clin Trials. 2015 May;42:196-203. doi: 10.1016/j.cct.2015.04.003. Epub 2015 Apr 11.
Intervention research in rural, health disparate communities presents unique challenges for study design, implementation, and evaluation. Challenges include 1) culturally appropriate intervention components, 2) participant recruitment and retention, 3) treatment cross-contamination, 4) intervention delivery and data collection, and 5) potential measurement reactivity.
The purposes of this paper are to 1) detail the methods of the MCHL study and 2) report baseline demographic characteristics of study participants. The secondary aim is to determine if study participants were engaging in behavior changes after enrollment and prior to intervention initiation.
MCHL was developed using the RE-AIM planning and evaluation framework (reach, effectiveness, adoption, implementation, maintenance). Intervention components were based on Roger's diffusion of innovation attributes that promote adoption of a new innovation as well as on the psychosocial constructs of social support, self-efficacy and decisional balance. Rolling enrollment data collection was used to acquire sufficient sample size and a second data collection just prior to intervention implementation assessed measurement reactivity effects. Participant outcomes included diet quality, blood pressure, weight status, and quality of life. Cluster stratified assignment to one of two treatment arms was utilized to minimize cross contamination. Generalized linear models were used to compare enrollment measures between the two treatment arms while mixed model linear regression was used to test for changes in diet quality outcomes from enrollment to pre-intervention baseline.
There were no significant differences in participant demographic, anthropometric or clinical measures between the two treatment arms at enrollment. With the exception of total vegetables, none of the diet quality indicators were significantly different between enrollment and baseline timepoints.
Conducting nutrition intervention research in a rural health disparate region requires flexibility in adapting the recruitment, retention, and data collection procedures while maintaining a high level of scientific rigor. Negligible research participation effects, such as measurement reactivity, were noted in this population. However, further research is needed to identify methods to successfully recruit and retain Caucasian females to participate in community-based nutrition interventions in this region.
在农村健康状况存在差异的社区进行干预研究,在研究设计、实施和评估方面面临独特挑战。挑战包括:1)符合文化背景的干预组成部分;2)参与者的招募与保留;3)治疗的交叉污染;4)干预实施与数据收集;5)潜在的测量反应性。
本文的目的是:1)详细介绍妇幼健康生活方式(MCHL)研究的方法;2)报告研究参与者的基线人口统计学特征。次要目的是确定研究参与者在入组后至干预开始前是否有行为改变。
妇幼健康生活方式研究采用RE-AIM计划与评估框架(覆盖范围、有效性、采用情况、实施情况、维持情况)开展。干预组成部分基于罗杰斯创新扩散属性(促进新创新的采用)以及社会支持、自我效能和决策平衡的心理社会结构。采用滚动入组数据收集以获取足够的样本量,并在干预实施前进行第二次数据收集以评估测量反应性影响。参与者的结果包括饮食质量、血压、体重状况和生活质量。采用整群分层分配至两个治疗组之一的方式以尽量减少交叉污染。使用广义线性模型比较两个治疗组之间的入组测量值,同时使用混合模型线性回归测试从入组到干预前基线期间饮食质量结果的变化。
入组时,两个治疗组在参与者人口统计学、人体测量学或临床测量方面无显著差异。除了蔬菜总量外,入组和基线时间点之间的饮食质量指标均无显著差异。
在农村健康状况存在差异的地区开展营养干预研究,需要在调整招募、保留和数据收集程序方面保持灵活性,同时维持高度的科学严谨性。在该人群中,测量反应性等研究参与效应可忽略不计。然而,需要进一步研究以确定成功招募和保留白人女性参与该地区社区营养干预的方法。