Nutrition and Coping Education for Symptom and Weight Management for Fibromyalgia

Study Overview
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Brief Summary
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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.

Official Title
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Lifestyle Modification Program for Overweight and Obese Fibromyalgia Patients

Conditions
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Fibromyalgia, Obesity

Intervention / Treatment
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* Behavioral: Lifestyle Modification
* Behavioral: Supportive education


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Fibromyalgia patients whose body mass index is greater than 25. Age 21-65 of both sex and all race. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lifestyle Modification<br>Behavioral: cognitive-motivational enhancement to lifestyle management plus nutritional education. | Behavioral: Lifestyle Modification<br>* 16 hours of motivational, lifestyle management session, 8 hours nutritional education.<br>|
| Active Comparator: Supportive education<br>General fibromyalgia education plus nutritional education. | Behavioral: Supportive education<br>* 16 hours general fibromyalgia education, 8 hours of nutritional education<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major FM syndrome symptoms and weight changes |  | Pre-treatment, Post-treatment, 3 follow-ups | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |