Nutrition and Coping Education for Symptom and Weight Management for Fibromyalgia

Obesity Clinical Trial

Official title:

Lifestyle Modification Program for Overweight and Obese Fibromyalgia Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00925431
• Other study ID #: 21744
• Secondary ID: R21AR055114
• Status: Completed
• Phase: N/A
• Start date: August 2009
• Est. completion date: September 2011

Study information

• Verified date: March 2017
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes
• Obesity

Intervention

Behavioral:
• Lifestyle Modification
16 hours of motivational, lifestyle management session, 8 hours nutritional education.
• Supportive education
16 hours general fibromyalgia education, 8 hours of nutritional education

Locations

Country	Name	City	State
United States	Pain Research Center, University of Utah	Salt Lake City	Utah

Sponsors (2)

Lead Sponsor	Collaborator
University of Utah	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major FM syndrome symptoms and weight changes		Pre-treatment, Post-treatment, 3 follow-ups
Secondary	Obesity-related health quality of life		Pre-treatment, Post-treatment, 3 month FU
Secondary	FMS-related neuroendocrine factors and obesity-related health indices		Pre-treatment, post-treatment, 3 month FU