Clinical trial NCT00925431: Nutrition and Coping Education for Symptom and Weight Management for Fibromyalgia
Official title: Lifestyle Modification Program for Overweight and Obese Fibromyalgia Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Obesity
Lead sponsor: University of Utah
Sponsor class: OTHER
Collaborators: name: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
First posted: 2009-06-22
Enrollment: 45
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Major FM syndrome symptoms and weight changes
timeFrame: Pre-treatment, Post-treatment, 3 follow-ups
Secondary outcomes:
measure: Obesity-related health quality of life
timeFrame: Pre-treatment, Post-treatment, 3 month FU
measure: FMS-related neuroendocrine factors and obesity-related health indices
timeFrame: Pre-treatment, post-treatment, 3 month FU
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: Pain Research Center, University of Utah
state: Utah
Study officials:
affiliation: University of Utah
name: Akiko Okifuji, PhD
role: PRINCIPAL_INVESTIGATOR
References: