Back to resultsNutrition and Coping Education for Symptom and Weight Management for Fibromyalgia
Primary Purpose
Fibromyalgia, Obesity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lifestyle Modification
Supportive education
Sponsored by
About this trial
This is an interventional treatment trial for Fibromyalgia
Eligibility 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
Sites / Locations
- Pain Research Center, University of Utah
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Lifestyle Modification
Supportive education
Arm Description
Behavioral: cognitive-motivational enhancement to lifestyle management plus nutritional education.
General fibromyalgia education plus nutritional education.
Outcomes
Primary Outcome Measures
Major FM syndrome symptoms and weight changes
Secondary Outcome Measures
Obesity-related health quality of life
FMS-related neuroendocrine factors and obesity-related health indices
Full Information
NCT ID
NCT00925431
First Posted
June 18, 2009
Last Updated
July 20, 2023
Sponsor
University of Utah
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
1. Study Identification
Unique Protocol Identification Number
NCT00925431
Brief Title
Nutrition and Coping Education for Symptom and Weight Management for Fibromyalgia
Official Title
Lifestyle Modification Program for Overweight and Obese Fibromyalgia Patients
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
September 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Utah
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia, Obesity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lifestyle Modification
Arm Type
Experimental
Arm Description
Behavioral: cognitive-motivational enhancement to lifestyle management plus nutritional education.
Arm Title
Supportive education
Arm Type
Active Comparator
Arm Description
General fibromyalgia education plus nutritional education.
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle Modification
Intervention Description
16 hours of motivational, lifestyle management session, 8 hours nutritional education.
Intervention Type
Behavioral
Intervention Name(s)
Supportive education
Intervention Description
16 hours general fibromyalgia education, 8 hours of nutritional education
Primary Outcome Measure Information:
Title
Major FM syndrome symptoms and weight changes
Time Frame
Pre-treatment, Post-treatment, 3 follow-ups
Secondary Outcome Measure Information:
Title
Obesity-related health quality of life
Time Frame
Pre-treatment, Post-treatment, 3 month FU
Title
FMS-related neuroendocrine factors and obesity-related health indices
Time Frame
Pre-treatment, post-treatment, 3 month FU
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Akiko Okifuji, PhD
Organizational Affiliation
University of Utah
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pain Research Center, University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84108
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Nutrition and Coping Education for Symptom and Weight Management for Fibromyalgia
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