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Nutrition and Coping Education for Symptom and Weight Management for Fibromyalgia

This study has been completed.
Sponsor:
Collaborator:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by (Responsible Party):
Akiko Okifuji, University of Utah
ClinicalTrials.gov Identifier:
NCT00925431
First received: June 18, 2009
Last updated: March 15, 2017
Last verified: March 2017
  Purpose
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 Intervention Phase
Fibromyalgia Obesity Behavioral: Lifestyle Modification Behavioral: Supportive education Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Lifestyle Modification Program for Overweight and Obese Fibromyalgia Patients

Resource links provided by NLM:


Further study details as provided by Akiko Okifuji, University of Utah:

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

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

Enrollment: 45
Study Start Date: August 2009
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   21 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00925431

Locations
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)
Investigators
Principal Investigator: Akiko Okifuji, PhD University of Utah
  More Information

Responsible Party: Akiko Okifuji, PhD, University of Utah
ClinicalTrials.gov Identifier: NCT00925431     History of Changes
Other Study ID Numbers: 21744
R21AR055114 ( U.S. NIH Grant/Contract )
Study First Received: June 18, 2009
Last Updated: March 15, 2017

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

ClinicalTrials.gov processed this record on September 21, 2017