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Nutrition and Coping Education for Symptom and Weight Management for Fibromyalgia

Utah System of Higher Education (USHE) logo

Utah System of Higher Education (USHE)

Status

Completed

Conditions

Fibromyalgia
Obesity

Treatments

Behavioral: Lifestyle Modification
Behavioral: Supportive education

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT00925431
21744
R21AR055114 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment

45 patients

Sex

All

Ages

21 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

45 participants in 2 patient groups

Lifestyle Modification
Experimental group
Description:
Behavioral: cognitive-motivational enhancement to lifestyle management plus nutritional education.
Treatment:
Behavioral: Lifestyle Modification
Supportive education
Active Comparator group
Description:
General fibromyalgia education plus nutritional education.
Treatment:
Behavioral: Supportive education

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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