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Nutrition and Coping Education for Symptom and Weight Management for Fibromyalgia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00925431
Recruitment Status : Completed
First Posted : June 22, 2009
Last Update Posted : March 17, 2017
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by (Responsible Party):
Akiko Okifuji, 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.

Condition or disease Intervention/treatment Phase
Fibromyalgia Obesity Behavioral: Lifestyle Modification Behavioral: Supportive education Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Lifestyle Modification Program for Overweight and Obese Fibromyalgia Patients
Study Start Date : August 2009
Actual Primary Completion Date : September 2011
Actual Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Lifestyle Modification
Behavioral: cognitive-motivational enhancement to lifestyle management plus nutritional education.
Behavioral: Lifestyle Modification
16 hours of motivational, lifestyle management session, 8 hours nutritional education.

Active Comparator: Supportive education
General fibromyalgia education plus nutritional education.
Behavioral: Supportive education
16 hours general fibromyalgia education, 8 hours of nutritional education

Primary Outcome Measures :
  1. Major FM syndrome symptoms and weight changes [ Time Frame: Pre-treatment, Post-treatment, 3 follow-ups ]

Secondary Outcome Measures :
  1. Obesity-related health quality of life [ Time Frame: Pre-treatment, Post-treatment, 3 month FU ]
  2. FMS-related neuroendocrine factors and obesity-related health indices [ Time Frame: Pre-treatment, post-treatment, 3 month FU ]

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00925431

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United States, Utah
Pain Research Center, University of Utah
Salt Lake City, Utah, United States, 84108
Sponsors and Collaborators
University of Utah
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
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Principal Investigator: Akiko Okifuji, PhD University of Utah

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Responsible Party: Akiko Okifuji, PhD, University of Utah Identifier: NCT00925431     History of Changes
Other Study ID Numbers: 21744
R21AR055114 ( U.S. NIH Grant/Contract )
First Posted: June 22, 2009    Key Record Dates
Last Update Posted: March 17, 2017
Last Verified: March 2017

Additional relevant MeSH terms:
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Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases