Nutrition and Coping Education for Symptom and Weight Management for Fibromyalgia
This study is ongoing, but not recruiting participants.
Sponsor:
University of Utah
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
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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
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 May 16, 2013