Fibromyalgia, Obesity
Conditions
Brief summary
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.
Interventions
BEHAVIORALLifestyle Modification
16 hours of motivational, lifestyle management session, 8 hours nutritional education.
BEHAVIORALSupportive education
16 hours general fibromyalgia education, 8 hours of nutritional education
Sponsors
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
University of Utah
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Major FM syndrome symptoms and weight changes | Pre-treatment, Post-treatment, 3 follow-ups |
Secondary
| Measure | 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 |
Countries
United States
Outcome results
None listed