Nutrition and Coping Education for Symptom and Weight Management for Fibromyalgia

Not Applicable

Completed

• Conditions: Obesity; Fibromyalgia
• Interventions: Behavioral: Supportive education; Behavioral: Lifestyle Modification

• Registration Number: NCT00925431
• Lead Sponsor: University of Utah

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-06-18
• Study First Submitted QC: 2009-06-19
• Study First Posted: 2009-06-22
• Study Start: 2009-08
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Status Verified: 2017-03
• Last Update Submitted: 2023-07-20
• Last Update Posted: 2023-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Supportive education	Supportive education	General fibromyalgia education plus nutritional education.
Lifestyle Modification	Lifestyle Modification	Behavioral: cognitive-motivational enhancement to lifestyle management plus nutritional education.

Primary Outcome Measures

Name	Time	Method
Major FM syndrome symptoms and weight changes	Pre-treatment, Post-treatment, 3 follow-ups

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Pain Research Center, University of Utah; 🇺🇸 Salt Lake City, Utah, United States