FibromyalgiaNCT00925431
Nutrition and Coping Education for Symptom and Weight Management for Fibromyalgia
A study testing Lifestyle Modification and Supportive education in people with Fibromyalgia and Obesity, run by University of Utah at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Fibromyalgia, Obesity
- What is being tested?
- Lifestyle Modification and Supportive education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2009to Sep 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Fibromyalgia patients whose body mass index is greater than 25.
- Age 21-65 of both sex and all race.
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Pain Research Center, University of Utah
Salt Lake City, Utah, 84108
About this study
Official title: Lifestyle Modification Program for Overweight and Obese Fibromyalgia Patients
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
- Being tested
- Lifestyle Modification, Supportive education
- Medical subject headings
- Fibromyalgia, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle ModificationBehavioural
16 hours of motivational, lifestyle management session, 8 hours nutritional education.
Supportive educationBehavioural
16 hours general fibromyalgia education, 8 hours of nutritional education
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle Modification | Experimental | Behavioral: cognitive-motivational enhancement to lifestyle management plus nutritional education. Receives: Behavioral: Lifestyle Modification |
| Supportive education | Active comparator | General fibromyalgia education plus nutritional education. Receives: Behavioral: Supportive education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major FM syndrome symptoms and weight changes
Measured: Pre-treatment, Post-treatment, 3 follow-ups
Secondary outcomes (2)
Obesity-related health quality of life
Measured: Pre-treatment, Post-treatment, 3 month FU
FMS-related neuroendocrine factors and obesity-related health indices
Measured: Pre-treatment, post-treatment, 3 month FU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2009 (estimated)
- Study startAug 2009
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Responsible party
- Principal investigator, Akiko Okifuji, University of Utah
- Investigators
- Akiko Okifuji, PhD, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00925431
- Sponsor's protocol ID
- 21744
- Other IDs
- R21AR055114
- Status last verified
- Mar 2017
- First submitted
- 18 Jun 2009
- Last updated
- 24 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lifestyle Modification Program for Overweight and Obese Fibromyalgia Patients
- ClinicalTrials.gov ID
- NCT00925431
- Acronym / sponsor ID
- 21744
- Conditions
- Fibromyalgia, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Study start
- Aug 2009
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 22 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lifestyle Modification | Experimental | Behavioral: Lifestyle ModificationBehavioral: cognitive-motivational enhancement to lifestyle management plus nutritional education. |
| Supportive education | Active comparator | Behavioral: Supportive educationGeneral fibromyalgia education plus nutritional education. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Fibromyalgia patients whose body mass index is greater than 25.
- Age 21-65 of both sex and all race.
Key exclusion criteria (13 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lifestyle Modification16 hours of motivational, lifestyle management session, 8 hours nutritional education. | Behavioural | Lifestyle Modification |
| Supportive education16 hours general fibromyalgia education, 8 hours of nutritional education | Behavioural | Supportive education |
Primary outcome
Major FM syndrome symptoms and weight changes
Time frame: Pre-treatment, Post-treatment, 3 follow-ups
2 secondary outcomes
Obesity-related health quality of life
Time frame: Pre-treatment, Post-treatment, 3 month FU
FMS-related neuroendocrine factors and obesity-related health indices
Time frame: Pre-treatment, post-treatment, 3 month FU
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Akiko Okifuji, PhD principal investigator
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle Modification and Supportive education in people with Fibromyalgia and Obesity, run by University of Utah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major FM syndrome symptoms and weight changes (time frame: Pre-treatment, Post-treatment, 3 follow-ups). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2023.