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临床试验/NCT00458094
NCT00458094已完成不适用

Activating Consumers to Exercise in Community Psychiatry Through Peer Support

Johns Hopkins University2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2007年3月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
2
主要终点
Cardiorespiratory fitness

研究概览

简要总结

This study will determine the effectiveness of a peer support system in increasing physical activity and effecting health behavior change in people with serious mental illnesses.

详细描述

People with serious mental illnesses (SMIs) are, by definition, significantly functionally impaired by the illness for an indefinite period of time. Schizophrenia, major depression, and bipolar disorder are considered SMIs. Severe anxiety disorders, cognitive disorders, and some personality disorders are sometimes categorized as SMIs, as well. The rate of obesity among people with SMIs is higher than that of people without mental illnesses. This disparity may be due to the negative symptoms that people with SMIs experience, such as vulnerability to stress, extreme dependency, and lack of motivation. This study will design and test a culturally appropriate physical activity intervention based on a peer support model for people with SMIs in an urban community psychiatry program. The intervention will be evaluated to determine its effectiveness in increasing physical activity and effecting health behavior change in people with SMIs.

Participants in this 4-month, open-label study will be randomly assigned to participate in either a physical activity intervention with peer support (PA+PS) or a physical activity intervention without peer support (PA). Participants in the PA+PS group will have three exercise sessions each week, which will include group exercise classes and open gym hours for supervised individual exercise. They will also meet with a peer educator once a week for 15 minutes. Peer educators will provide emotional, informational, instrumental, and appraisal support that is aimed to motivate participants to partake in the exercise sessions. Participants in the PA group will attend the three weekly exercise sessions but will not attend meetings with the peer educator. All outcomes will be assessed at a follow-up visit at the end of the intervention.

研究设计

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

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient at the Johns Hopkins Community Psychiatry program
  • Plans to remain in Baltimore for 8 months after study entry
  • If currently breastfeeding, has received approval from a physician to participate in the study

排除标准

  • Any condition that would make weight loss medically inadvisable
  • Diagnosis of or treatment for cancer (except non-melanoma skin cancer) within 2 years prior to study entry
  • Liver failure
  • History of anorexia nervosa
  • Pregnant or planning to become pregnant during the study
  • Inability to walk or participate in an exercise class
  • Consumes more than 14 alcoholic drinks per week
  • Symptoms of angina or a cardiovascular event within 6 months prior to study entry

研究组 & 干预措施

1

Experimental

Participants will receive the peer-supported physical activity intervention

干预措施: Physical activity intervention with peer support (PA+PS) (Behavioral)

2

Active Comparator

Participants will receive physical activity without peer support

干预措施: Physical activity intervention without peer support (PA) (Behavioral)

结局指标

主要结局

Cardiorespiratory fitness

时间窗: Measured at Month 4

次要结局

  • Center for Epidemiology Depression Scale(Measured at Month 4)
  • Waist circumference(Measured at Month 4)
  • Health status(Measured at Month 4)
  • General perceived efficacy(Measured at Month 4)
  • Weight(Measured at Month 4)
  • Physical activity(Measured at Month 4)
  • Exercise-related self-efficacy(Measured at Month 4)
  • Participation(Measured at Month 4)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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