Nutrition and Coping Education for Symptom and Weight Management for Fibromyalgia

NCT00925431 | Completed DMC

• 2 other identifiers: 21744R21AR055114
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Fibromyalgia; Obesity

Outcome Measures

Primary Outcomes (1)

• Major FM syndrome symptoms and weight changes

  Pre-treatment, Post-treatment, 3 follow-ups

Secondary Outcomes (2)

• Obesity-related health quality of life

  Pre-treatment, Post-treatment, 3 month FU

• FMS-related neuroendocrine factors and obesity-related health indices

  Pre-treatment, post-treatment, 3 month FU

Study Arms (2)

Lifestyle Modification

EXPERIMENTAL

Behavioral: cognitive-motivational enhancement to lifestyle management plus nutritional education.

Behavioral: Lifestyle Modification

Supportive education

ACTIVE COMPARATOR

General fibromyalgia education plus nutritional education.

Behavioral: Supportive education

Interventions

Lifestyle Modification BEHAVIORAL

16 hours of motivational, lifestyle management session, 8 hours nutritional education.

Lifestyle Modification

Supportive education BEHAVIORAL

16 hours general fibromyalgia education, 8 hours of nutritional education

Supportive education

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Fibromyalgia patients whose body mass index is greater than 25.
• Age 21-65 of both sex and all race.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Utah: lead
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator

Study Sites (1)

Pain Research Center, University of Utah

Salt Lake City, Utah, 84108, United States

Location

MeSH Terms

Conditions

Fibromyalgia; Obesity

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Akiko Okifuji, PhD

  University of Utah

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: June 18, 2009
• First Posted: June 22, 2009
• Study Start: August 1, 2009
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: July 24, 2023

Record last verified: 2017-03

Locations

US (1)