Obesity/Overweight in Persons With Early and Chronic Spinal Cord Injury (SCI)
Obesity/Overweight in Persons With Early and Chronic SCI: A Randomized Multi-Center Controlled Lifestyle Intervention
研究概览
详细说明
The study plan will enroll 80 persons with Spinal Cord Injury (SCI) who are overweight/obese and have fasting atherogenic dyslipidemia and dysglycemia. A Data Safety Management Board will oversee the trial. Interventions will include 6 months of structured lifestyle intervention incorporating education, exercise, diet, and behavioral support A second arm will test benefits of exercise alone while controlling for investigator contact. Multiple baselines tested before intervention will serve as a treatment control.
Exercise will include a six-month circuit resistance training program already established as effective in fitness attainment for persons with paraplegia and tetraplegia. Dietary intervention over the same period will balance caloric expenditure measured by indirect calorimetry and food intake, the latter coming from a Mediterranean style diet having effectiveness established in the DPP for durable weight loss and diabetes prevention. The investigators and personal 'lifestyle coaches' will then shape and follow client-specific exercise and diet programs to be conducted for 12 months in the home or community-based centers. Behavioral approaches will include a 16-week training curriculum presented in both small groups and with the lifestyle coaches. Other behavioral approaches will include customized trial information booklets, performance incentives, outcome challenges between centers, and use of the VA Telehealth system for performance tracking, compliance assessment, and motivational support.
Study specific aims and their accompanying hypotheses will test effects of intervention on: 1) reducing body weight and radiographically-derived body fat, 2) improving fitness as assessed by endurance, strength, and anaerobic power, 3) reducing risks of fasting dyslipidemia, post-prandial lipemia, and insulin resistance, and 4) enhancing perceived health-related quality of life. Data will be analyzed by Multivariate analysis with repeated measures. Ancillary testing will investigate effects of intervention on the whole body oxidation of fat at rest and following food intake, and examine the relationship between dietary intake and caloric expenditure at the beginning and the end of the 18 month study. The primary trial goal pays fidelity to the DPP by targeting sustained loss of 7% of body weight, a proven countermeasure for prevention of diabetes. Positive results of training will represent the first evidence-based randomized multi-center trial of sustained weight loss in persons with SCI - military or civilian. In the near term the data will provide evidence needed to initiate health reform of military and non-military constituencies with disability. The information will also underwrite changes in dietary support of newly injured persons. The information will further provide a roadmap for clinicians to institute client-centered programs of health planning and recovery. As the extension phase will test both home and community-based programs, deployment to wider military constituencies of persons with SCI can be achieved through VA Community Outpatient Clinics. The trial can also become a roadmap to weight and disease management experience by persons with physical impairments other than SCI.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Florida
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Miami、Florida、美国、33136
- University of Miami
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- participants will include 64 men and women aged 18-65 years with SCI (AIS A-C) at the C5-L1 levels for more than 1 year.
- the International Standards for Neurological Classification of SCI (ASIA/ISCoS) will serve as benchmarks for subject classification. A physician-rater experienced in these procedures will classify subjects upon study entry.
Exclusion Criteria:
Study candidates will be excluded from study because of:
- structured exercise conditioning for recreation or competition within 6 months of study entry;
- defined diet involving caloric restriction or nutrient modification;
- weight loss or gain of 5% within the preceding 6 months;
- surgery within 6 months;
- pressure ulcer within 3 months;
- upper limb pain that limits exercise;
- recurrent acute infection or illness requiring hospitalization or IV antibiotics;
- pregnancy;
- previous MI or cardiac surgery;
- 6 month history of glucose-lowering and lipid-lowering drug therapy;
- Type I or II diabetes (by WHO criteria); and
- daily intake of vitamin supplements exceeding 100% RDA.
学习计划
研究是如何设计的?
设计细节
- 主要用途:卫生服务研究
- 分配:随机化
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:Lifestyle Intervention
This arm will test the combination of 6 months of structured lifestyle intervention incorporating education, exercise, diet, and behavioral support.
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The intervention incorporates 6 months of active structured lifestyle intervention containing participant education, exercise, dietary intervention, and behavioral support
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安慰剂比较:Exercise Control
This arm will test the benefits of exercise alone while controlling for investigator contact.
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The control group intervention will test benefits of exercise alone while controlling for investigator contact.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Body mass
大体时间:12 months
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Study specific aims and their accompanying hypotheses will test effect of intervention on:1)reducing body weight and radiographically-derived body fat, 2)improving fitness as assessed by endurance, strength, and anaerobic power,3) reducing risks of fasting dyslipidemia, post-prandial lipemia, and insulin resistance, and 4) enhancing perceived health-related quality of life.
the primary trial goal pays fidelity to the DPP by targeting sustained loss of 7% of body weight, a proven countermeasure for prevention of diabetes.
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12 months
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合作者和调查者
调查人员
- 首席研究员:Mark S Nash, PhD、University of Miami
出版物和有用的链接
有用的网址
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
其他研究编号
- TMP-MN-009
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
Lifestyle Intervention的临床试验
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University of Wisconsin, MadisonNational Cancer Institute (NCI); Northwestern University主动,不招人
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University of Illinois at ChicagoShirley Ryan AbilityLab; Oakland University; Access Living主动,不招人
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Medical University of South CarolinaNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)完全的肥胖 | 心血管危险因素 | 糖尿病风险