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OpenTrials
Completed

NCT Number: NCT00925431

Nutrition and Coping Education for Symptom and Weight Management for Fibromyalgia

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.

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Key information

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pain Research Center, University of Utah

Salt Lake City, Utah, 84108, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lifestyle Modification

Behavioral

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

Supportive Education

Behavioral

16 hours general fibromyalgia education, 8 hours of nutritional education

Primary outcomes

  1. Major FM syndrome symptoms and weight changes

    Time frame: Pre-treatment, Post-treatment, 3 follow-ups

Secondary outcomes

  1. Obesity-related health quality of life

    Time frame: Pre-treatment, Post-treatment, 3 month FU

  2. FMS-related neuroendocrine factors and obesity-related health indices

    Time frame: Pre-treatment, post-treatment, 3 month FU

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Collaborators

  • National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Registry information

Official study title

Lifestyle Modification Program for Overweight and Obese Fibromyalgia Patients

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Jun 22, 2009
Registry last updated
Jul 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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