Nutrition and Coping Education for Symptom and Weight Management for Fibromyalgia
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|ClinicalTrials.gov Identifier: NCT00925431|
Recruitment Status : Completed
First Posted : June 22, 2009
Last Update Posted : March 17, 2017
|Condition or disease||Intervention/treatment||Phase|
|Fibromyalgia Obesity||Behavioral: Lifestyle Modification Behavioral: Supportive education||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||45 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Lifestyle Modification Program for Overweight and Obese Fibromyalgia Patients|
|Study Start Date :||August 2009|
|Actual Primary Completion Date :||September 2011|
|Actual Study Completion Date :||September 2011|
Experimental: Lifestyle Modification
Behavioral: cognitive-motivational enhancement to lifestyle management plus nutritional education.
Behavioral: Lifestyle Modification
16 hours of motivational, lifestyle management session, 8 hours nutritional education.
Active Comparator: Supportive education
General fibromyalgia education plus nutritional education.
Behavioral: Supportive education
16 hours general fibromyalgia education, 8 hours of nutritional education
- Major FM syndrome symptoms and weight changes [ Time Frame: Pre-treatment, Post-treatment, 3 follow-ups ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00925431
|United States, Utah|
|Pain Research Center, University of Utah|
|Salt Lake City, Utah, United States, 84108|
|Principal Investigator:||Akiko Okifuji, PhD||University of Utah|