Health Promotion for Women With Fibromyalgia
2 other identifiers
interventional
177
1 country
1
Brief Summary
Women with chronic disabling conditions such as fibromyalgia syndrome (FMS) must manage a wide variety of disease-related, intrapersonal, and environmental demands to maintain their health and quality of life. Engaging in health-promoting behaviors is one strategy recommended to manage disease symptoms and enhance quality of life (USDHHS, 2000). The purpose of this four-year study is to refine and test a theoretically and empirically based intervention to promote the health and well being of women with the chronic disabling condition of fibromyalgia. We hypothesize that women who participate in the "Lifestyle Counts" Intervention will report more greater self-efficacy for health behaviors, more frequent health behaviors and more positive health and quality of life than women in the comparison group.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2003
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2007
CompletedFirst Submitted
Initial submission to the registry
January 8, 2008
CompletedFirst Posted
Study publicly available on registry
January 17, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2008
CompletedApril 25, 2012
April 1, 2012
3.5 years
January 8, 2008
April 24, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
SF36 Subscales
Baseline, 2 months, 5 months and 8 months
Secondary Outcomes (2)
Fibromyalgia Impact Questionnaire
Baseline, 2 months, 5 months, 8 months
Health Behaviors - The Health Promoting Lifestyle Questionnaire
Baseline, 2 months, 5 months 8 months
Study Arms (2)
Lifestyle Counts Intervention
EXPERIMENTALA wellness intervention that includes 8 weeks of behavior change classes focused on acquiring the skills and knowledge to improve health behaviors (e.g., exercise, stress management), followed by 3 months of phone support.
Attention Countrol
PLACEBO COMPARATOR8 weeks of general health classes followed by phone calls for 3 months
Interventions
8 weeks of classes focused on health behavior change, individualized goal setting and 3 months of follow-up phone support
8 weeks of classes on general health information topics followed by 3 months of phone calls to solicit questions
Eligibility Criteria
You may qualify if:
- Female
- Physician verified diagnosis of Fibromyalgia for at least 6 months, age 18 to 75,
- Able to speak and read English
- Willing to participate in 8-month intervention study
You may not qualify if:
- Pregnancy
- Male
- Concurrent medical conditions (as judged by their physician) for which changes in diet and exercise would be contraindicated
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The University of Texas at Austin
Austin, Texas, 78701, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alexa Stuifbergen, PhD, RN
The University of Texas at Austin School of Nursing
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
- SPONSOR
Study Record Dates
First Submitted
January 8, 2008
First Posted
January 17, 2008
Study Start
July 1, 2003
Primary Completion
January 1, 2007
Study Completion
May 1, 2008
Last Updated
April 25, 2012
Record last verified: 2012-04