Health Promotion for Women With Fibromyalgia
研究概览
详细说明
This wellness intervention, originally developed and tested in a randomized clinical trial of women with MS (N=113), resulted in significant improvements in self-efficacy, health behaviors and improvements in pain, social functioning, mental health and emotional role-functioning. The specific aims of this study are to examine the effects of the adapted wellness intervention on self-efficacy, resources, barriers, health behaviors and health outcomes for women with fibromyalgia.
A sample of 160 women with FMS will be recruited to participate in a randomized clinical study to determine the effects of this wellness intervention that includes an eight week health promotion/behavior change component and 3 months of follow-up phone support. Content regarding stress management, lifestyle adjustment, physical activity, nutrition and women's health issues will be presented with an emphasis on the unique adaptations and associated skills required to empower women with the tools for exercising personal control over their health behaviors. The effects of the intervention on outcome variables will be assessed over an 8-month period with measurements at baseline, 2 months (immediately after the educational/skill-building component), 5 months (after 3 months of phone support) and at 8 months.
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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Texas
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Austin、Texas、美国、78701
- The University of Texas at Austin
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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:
- Female
- Physician verified diagnosis of Fibromyalgia for at least 6 months, age 18 to 75,
- Able to speak and read English
- Willing to participate in 8-month intervention study
Exclusion Criteria:
- Pregnancy
- Male
- Concurrent medical conditions (as judged by their physician) for which changes in diet and exercise would be contraindicated
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：Lifestyle Counts Intervention
A wellness intervention that includes 8 weeks of behavior change classes focused on acquiring the skills and knowledge to improve health behaviors (e.g., exercise, stress management), followed by 3 months of phone support.
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8 weeks of classes focused on health behavior change, individualized goal setting and 3 months of follow-up phone support
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安慰剂比较：Attention Countrol
8 weeks of general health classes followed by phone calls for 3 months
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8 weeks of classes on general health information topics followed by 3 months of phone calls to solicit questions
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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SF36 Subscales
大体时间：Baseline, 2 months, 5 months and 8 months
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Baseline, 2 months, 5 months and 8 months
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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Fibromyalgia Impact Questionnaire
大体时间：Baseline, 2 months, 5 months, 8 months
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Baseline, 2 months, 5 months, 8 months
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Health Behaviors - The Health Promoting Lifestyle Questionnaire
大体时间：Baseline, 2 months, 5 months 8 months
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Baseline, 2 months, 5 months 8 months
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合作者和调查者
调查人员
- 首席研究员：Alexa Stuifbergen, PhD, RN、The University of Texas at Austin School of Nursing
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
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 Counts的临床试验
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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