Expired Study
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Austin, Texas 78701


Purpose:

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.


Study summary:

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.


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


Study is Available At:


Original ID:

2002-08-0043


NCT ID:

NCT00596674


Secondary ID:

R01HD035047


Study Acronym:


Brief Title:

Health Promotion for Women With Fibromyalgia


Official Title:

Health Promotion for Women With Fibromyalgia


Overall Status:

Completed


Study Phase:

N/A


Genders:

Female


Minimum Age:

18 Years


Maximum Age:

75 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Texas at Austin


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

177


Enrollment Type:

Actual


Overall Contact Information

Official Name:Alexa Stuifbergen, PhD, RN
Principal Investigator
The University of Texas at Austin School of Nursing

Study Dates

Start Date:July 2003
Completion Date:May 2008
Completion Type:Actual
Primary Completion Date:January 2007
Primary Completion Type:Actual
Verification Date:April 2012
Last Changed Date:April 24, 2012
First Received Date:January 8, 2008

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Health Behaviors - The Health Promoting Lifestyle Questionnaire
Time Frame:Baseline, 2 months, 5 months 8 months
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Fibromyalgia Impact Questionnaire
Time Frame:Baseline, 2 months, 5 months, 8 months
Safety Issues:False
Outcome Type:Primary Outcome
Measure:SF36 Subscales
Time Frame:Baseline, 2 months, 5 months and 8 months
Safety Issues:False

Study Interventions

Intervention Type:Behavioral
Name:Lifestyle Counts
Description:8 weeks of classes focused on health behavior change, individualized goal setting and 3 months of follow-up phone support
Arm Name:Lifestyle Counts Intervention
Intervention Type:Other
Name:Attention Control
Description:8 weeks of classes on general health information topics followed by 3 months of phone calls to solicit questions
Arm Name:Attention Countrol

Study Arms

Study Arm Type:Experimental
Arm Name:Lifestyle Counts Intervention
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.
Study Arm Type:Placebo Comparator
Arm Name:Attention Countrol
Description:8 weeks of general health classes followed by phone calls for 3 months

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Texas at Austin
Agency Class:NIH
Agency Type:Collaborator
Agency Name:Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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