Health Promotion for Women With Fibromyalgia
Primary Purpose
Fibromyalgia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lifestyle Counts
Attention Control
Sponsored by
About this trial
This is an interventional treatment trial for Fibromyalgia focused on measuring Women, Fibromyalgia Syndrome, Health Behaviors, Quality of Life
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- Pregnancy
- Male
- Concurrent medical conditions (as judged by their physician) for which changes in diet and exercise would be contraindicated
Sites / Locations
- The University of Texas at Austin
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Lifestyle Counts Intervention
Attention Countrol
Arm Description
A 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.
8 weeks of general health classes followed by phone calls for 3 months
Outcomes
Primary Outcome Measures
SF36 Subscales
Secondary Outcome Measures
Fibromyalgia Impact Questionnaire
Health Behaviors - The Health Promoting Lifestyle Questionnaire
Full Information
NCT ID
NCT00596674
First Posted
January 8, 2008
Last Updated
April 24, 2012
Sponsor
University of Texas at Austin
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
1. Study Identification
Unique Protocol Identification Number
NCT00596674
Brief Title
Health Promotion for Women With Fibromyalgia
Official Title
Health Promotion for Women With Fibromyalgia
Study Type
Interventional
2. Study Status
Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
July 2003 (undefined)
Primary Completion Date
January 2007 (Actual)
Study Completion Date
May 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Texas at Austin
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
This wellness intervention, originally developed and tested in a randomized clinical trial of women with MS (N=113), resulted in significant improvements in self-efficacy, health behaviors and improvements in pain, social functioning, mental health and emotional role-functioning. The specific aims of this study are to examine the effects of the adapted wellness intervention on self-efficacy, resources, barriers, health behaviors and health outcomes for women with fibromyalgia.
A sample of 160 women with FMS will be recruited to participate in a randomized clinical study to determine the effects of this wellness intervention that includes an eight week health promotion/behavior change component and 3 months of follow-up phone support. Content regarding stress management, lifestyle adjustment, physical activity, nutrition and women's health issues will be presented with an emphasis on the unique adaptations and associated skills required to empower women with the tools for exercising personal control over their health behaviors. The effects of the intervention on outcome variables will be assessed over an 8-month period with measurements at baseline, 2 months (immediately after the educational/skill-building component), 5 months (after 3 months of phone support) and at 8 months.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
Keywords
Women, Fibromyalgia Syndrome, Health Behaviors, Quality of Life
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
177 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lifestyle Counts Intervention
Arm Type
Experimental
Arm Description
A 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.
Arm Title
Attention Countrol
Arm Type
Placebo Comparator
Arm Description
8 weeks of general health classes followed by phone calls for 3 months
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle Counts
Intervention Description
8 weeks of classes focused on health behavior change, individualized goal setting and 3 months of follow-up phone support
Intervention Type
Other
Intervention Name(s)
Attention Control
Intervention Description
8 weeks of classes on general health information topics followed by 3 months of phone calls to solicit questions
Primary Outcome Measure Information:
Title
SF36 Subscales
Time Frame
Baseline, 2 months, 5 months and 8 months
Secondary Outcome Measure Information:
Title
Fibromyalgia Impact Questionnaire
Time Frame
Baseline, 2 months, 5 months, 8 months
Title
Health Behaviors - The Health Promoting Lifestyle Questionnaire
Time Frame
Baseline, 2 months, 5 months 8 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
Pregnancy
Male
Concurrent medical conditions (as judged by their physician) for which changes in diet and exercise would be contraindicated
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexa Stuifbergen, PhD, RN
Organizational Affiliation
The University of Texas at Austin School of Nursing
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas at Austin
City
Austin
State/Province
Texas
ZIP/Postal Code
78701
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Health Promotion for Women With Fibromyalgia
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