Nutrition and Coping Education for Symptom and Weight Management for Fibromyalgia

NCT ID: NCT00925431

Last Updated: 2023-07-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2011-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Fibromyalgia Obesity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Lifestyle Modification

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

Group Type EXPERIMENTAL

Lifestyle Modification

Intervention Type BEHAVIORAL

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

Supportive education

General fibromyalgia education plus nutritional education.

Group Type ACTIVE_COMPARATOR

Supportive education

Intervention Type BEHAVIORAL

16 hours general fibromyalgia education, 8 hours of nutritional education

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Lifestyle Modification

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

Intervention Type BEHAVIORAL

Supportive education

16 hours general fibromyalgia education, 8 hours of nutritional education

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

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

NIH

Sponsor Role collaborator

University of Utah

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Akiko Okifuji

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Akiko Okifuji, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Utah

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Pain Research Center, University of Utah

Salt Lake City, Utah, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

R21AR055114

Identifier Type: NIH

Identifier Source: secondary_id

View Link

21744

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Tailored Treatments of Fibromyalgia
NCT00000422 COMPLETED PHASE2/PHASE3
Yoga for Fibromyalgia
NCT00966732 COMPLETED NA