Nutrition and Coping Education for Symptom and Weight Management for Fibromyalgia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by University of Utah.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
University of Utah
ClinicalTrials.gov Identifier:
NCT00925431
First received: June 18, 2009
Last updated: July 2, 2012
Last verified: July 2012
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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 University of Utah:

Primary Outcome Measures:
  • Major FM syndrome symptoms and weight changes [ Time Frame: Pre-treatment, Post-treatment, 3 follow-ups ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Obesity-related health quality of life [ Time Frame: Pre-treatment, Post-treatment, 3 month FU ] [ Designated as safety issue: No ]
  • FMS-related neuroendocrine factors and obesity-related health indices [ Time Frame: Pre-treatment, post-treatment, 3 month FU ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: August 2009
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: August 2012 (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
Genders Eligible for Study:   Both
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
Investigators
Principal Investigator: Akiko Okifuji, PhD University of Utah
  More Information

No publications provided

Responsible Party: University of Utah
ClinicalTrials.gov Identifier: NCT00925431     History of Changes
Other Study ID Numbers: 21744, R21AR055114
Study First Received: June 18, 2009
Last Updated: July 2, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Obesity
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on July 28, 2014