Lifestyle Modification Program for Overweight and Obese Fibromyalgia Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Major FM syndrome symptoms and weight changes
研究概览
简要总结
Research has shown that weight problems are very common in fibromyalgia. Research also suggests that overweight and obesity may contribute to worsening of fibromyalgia symptoms and biochemical vulnerability associated with fibromyalgia. Effective weight management may be important in not only improving general health but also better management of fibromyalgia symptoms. Research has indicated that nutrition and coping education is important aspects of successful weight management. In this study, the investigators are evaluating the effect of nutrition and coping education on weight and symptom management of fibromyalgia among overweight and obese patients.
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
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Fibromyalgia patients whose body mass index is greater than
- •Age 21-65 of both sex and all race.
排除标准
- •Co-occurring progressive disease
- •Planning to have surgery in the next year
- •Pregnancy or planning to be pregnant in the next year
- •Having known cardiovascular diseases
- •Having known serious psychopathology (Diagnoses of psychosis, organic mental disorder, dissociative disorder, active suicidal intent, inpatient admission to psychiatric ward in the past year, evidence of self-injurious behaviors in the past year, current or recent history (2years) of non-IV substance abuse, any history of recreational IV drug use)
- •Having autoimmune disorder (e.g., rheumatoid arthritis)
- •Having neuropathic pain
- •Having pain associated with terminal illness, acute pain, pain associated with specific organ damage (eg, stomach ulcer)
- •Concurrent use of weight controlling medications (eg, Xenical)
- •A history of weight reduction surgery
- •Concurrent participation in weight loss programs or other cognitive-behavioral coping therapy
- •Self-reported physician diagnosed conditions of chronic bronchitis, asthma, or emphysema
- •Report history of head injury, neurological illness, diagnosis of learning disability, learning problems, or special education, substantial toxin or chemical exposure within five years of FMS onset, near drowning, recreational IV drug use
结局指标
主要结局
Major FM syndrome symptoms and weight changes
时间窗: Pre-treatment, Post-treatment, 3 follow-ups
次要结局
- Obesity-related health quality of life(Pre-treatment, Post-treatment, 3 month FU)
- FMS-related neuroendocrine factors and obesity-related health indices(Pre-treatment, post-treatment, 3 month FU)