跳至主要内容
临床试验/NCT01776034
NCT01776034已完成不适用

Examining the Efficacy of a SystemCHANGE™ Weight Management Intervention in Stroke Survivors and Persons With Chronic Inflammatory Autoimmune/Immune-mediated Diseases

Case Western Reserve University2 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2013年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
66
试验地点
2
主要终点
Changes from baseline in body weight.

研究概览

简要总结

The objective of this study is to conduct a randomized controlled pilot study to examine the efficacy, feasibility and safety of the SystemCHANGE™(SC) health promotion and wellness program in adults with disabling conditions. Particularly, the study will focus on developing a program of research on adapting and testing SC weight management interventions in overweight and obese stroke survivors and persons with chronic inflammatory autoimmune/immune-mediated diseases, specifically those with multiple sclerosis (MS) and rheumatoid arthritis (RA).

详细描述

Individuals with disabling conditions, such as stroke, multiple sclerosis, or rheumatoid arthritis, face many barriers to engaging in physical activity, healthy nutritional habits, and good sleep hygiene. This leads to weight gain, de-conditioning, and declines in upper- and lower- extremity function, which makes it even more difficult to engage in healthy behaviors, thereby perpetuating a cycle of functional decline. Developing an effective weight management intervention may be a strategy for disrupting this disabling cycle and reducing the impact of the disease. Fostering a positive social environment may help adults with disabling conditions overcome barriers to engaging in healthy behaviors. SystemCHANGE (SC) is a new behavior change program that uses approaches consistent with social ecological theories and process improvement techniques (i.e. changing the dynamics of a system or group) to increase social support in lifestyle behaviors that promote energy balance. SC focuses on redesigning the social environment using a series of trial-and-error "experiments", which is in contrast to cognitive-behavioral interventions that focus on changing a person's viewpoint of a situation and increasing motivation. In a SC intervention, individuals are taught a set of skills to assist them in incorporating habitual lifestyle behaviors into their daily systems so they succeed despite wavering motivation. The rationale for developing a weight management intervention for these patients is to slow disability progression and prevent secondary conditions.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
30 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Changes from baseline in body weight.

时间窗: Each patient will be given the assessments at 2 points during the study, at baseline and at posttest (an average of 6 months from baseline).

A digital scale will be used to measure Body weight.

次要结局

  • Changes from baseline in cardiovascular risk biomarkers.(Each patient will be given the assessments at 2 points during the study, at baseline and at posttest (an average of 6 months from baseline).)
  • Changes from baseline in Walking Test.(Each patient will be given the assessments at 2 points during the study, at baseline and at posttest (an average of 6 months from baseline).)
  • Changes from baseline in 1-minute sit to stand test(Each patient will be given the assessments at 2 points during the study, at baseline and at posttest (an average of 6 months from baseline).)
  • Changes from baseline Physical Activity(Each patient will be given the assessments at 2 points during the study, at baseline and at posttest (an average of 6 months from baseline).)
  • Changes from baseline Self-efficacy for weight management(Each patient will be given the assessments at 2 points during the study, at baseline and at posttest (an average of 6 months from baseline).)
  • Changes from baseline social support for physical activity from family(Each patient will be given the assessments at 2 points during the study, at baseline and at posttest (an average of 6 months from baseline).)
  • Changes from baseline in emotional well-being(Each patient will be given the assessments at 2 points during the study, at baseline and at posttest (an average of 6 months from baseline).)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Matthew Plow

Assistant Professor

Case Western Reserve University

研究点 (2)

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