Lieberman Jesse A, McClelland Jacquelyn W, Goff David C, Racine Elizabeth, Dulin Michael F, Bauman William A, Niemeier Janet, Hirsch Mark A, Norton H James, Moore Charity G
Carolinas Rehabilitation, 1100 Blythe Boulevard, Charlotte, NC, 28203, USA.
North Carolina State University, Campus Box 7606, Raleigh, NC, 27695, USA.
Trials. 2017 Dec 4;18(1):584. doi: 10.1186/s13063-017-2263-2.
Individuals with chronic spinal cord injuries (SCIs) have an increased prevalence of cardiovascular disease (CVD) and associated risk factors compared with age-matched control subjects. Exercise has been shown to improve selected CVD risk factors in individuals with SCI, but using nutrition education as an intervention has not been evaluated in this population. This paper describes our research plan for evaluating the effect of nutrition education on individuals with SCI. In the present study, called Eat Smart, Live Better, we are using a randomized controlled design to test an intervention adapted from an existing evidence-based program that showed a positive effect on nutrition knowledge and behavior of older adults from the general population. There will be an inpatient group (n = 100) and a community group (n = 100). The aims of our study are to compare the intervention and control groups for (1) changes in nutritional behavior, nutritional knowledge, and dietary quality by participants in the program; (2) levels of adiposity and metabolic CVD risk factors at 12-month follow-up; and (3) differential effects among individuals with SCI in the acute rehabilitation setting and those living in the community.
METHODS/DESIGN: This is a randomized controlled trial of nutrition education. The treatment groups receive six nutrition education sessions. The control groups receive the one "standard of care" nutrition lecture that is required by the Commission on Accreditation of Rehabilitation Facilities. Treatment groups include both an inpatient group, comprising patients who have been admitted to an acute rehabilitation facility because of their recent SCI, and an outpatient group, consisting of community-dwelling adults who are at least 1 year after their SCI. A total of 200 participants will be randomized 1:1 to the intervention or control group, stratified by location (acute rehabilitation facility or community dwelling).
To our knowledge, this will be the first reported study of nutrition education in individuals with SCI. The low cost and feasibility of the intervention, if shown to improve nutritional behavior, suggests that it could be implemented in rehabilitation facilities across the country. This has the potential of lowering the burden of CVD and CVD risk factors in this high-risk population.
ClinicalTrials.gov, NCT02368405 . Registered on February 10, 2015.
与年龄匹配的对照受试者相比，慢性脊髓损伤（SCI）患者心血管疾病（CVD）及相关危险因素的患病率更高。运动已被证明可改善SCI患者某些CVD危险因素，但尚未对该人群采用营养教育作为干预措施进行评估。本文描述了我们评估营养教育对SCI患者影响的研究计划。在本名为“吃得明智，活得更好”的研究中，我们采用随机对照设计，来测试一项基于现有循证项目改编的干预措施，该项目对普通人群中的老年人的营养知识和行为产生了积极影响。将有一个住院组（n = 100）和一个社区组（n = 100）。我们研究的目的是比较干预组和对照组在以下方面的情况：（1）项目参与者的营养行为、营养知识和饮食质量的变化；（2）12个月随访时的肥胖水平和代谢性CVD危险因素；（3）急性康复环境中的SCI患者与社区居住的SCI患者之间的差异效应。
方法/设计：这是一项营养教育的随机对照试验。治疗组接受六次营养教育课程。对照组接受康复设施认证委员会要求的一次“标准护理”营养讲座。治疗组包括一个住院组，由因近期SCI而入住急性康复设施的患者组成，以及一个门诊组，由SCI后至少1年的社区居住成年人组成。总共200名参与者将按1:1随机分配到干预组或对照组，按地点（急性康复设施或社区居住）分层。
据我们所知，这将是第一项报道的关于SCI患者营养教育的研究。如果该干预措施被证明能改善营养行为，其低成本和可行性表明它可以在全国的康复设施中实施。这有可能降低这一高危人群中CVD及其危险因素的负担。
ClinicalTrials.gov，NCT02368405。于2015年2月10日注册。
