FibromyalgiaNCT00596674
Health Promotion for Women With Fibromyalgia
A study testing Lifestyle Counts in people with Fibromyalgia, run by University of Texas at Austin at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Lifestyle Counts
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 177 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2003to May 2008
- 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 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Pregnancy
- Male
- Concurrent medical conditions (as judged by their physician) for which changes in diet and exercise would be contraindicated
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas at Austin
Austin, Texas, 78701
About this study
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.
Read the 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.
- Conditions
- Fibromyalgia
- Being tested
- Lifestyle Counts, Attention Control
- Keywords
- Women, Fibromyalgia Syndrome, Health Behaviors, Quality of Life
- Medical subject headings
- Fibromyalgia, Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle CountsBehavioural
8 weeks of classes focused on health behavior change, individualized goal setting and 3 months of follow-up phone support
Attention ControlOther
8 weeks of classes on general health information topics followed by 3 months of phone calls to solicit questions
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle Counts Intervention | Experimental | 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. Receives: Behavioral: Lifestyle Counts |
| Attention Countrol | Placebo comparator | 8 weeks of general health classes followed by phone calls for 3 months Receives: Other: Attention Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
SF36 Subscales
Measured: Baseline, 2 months, 5 months and 8 months
Secondary outcomes (2)
Fibromyalgia Impact Questionnaire
Measured: Baseline, 2 months, 5 months, 8 months
Health Behaviors - The Health Promoting Lifestyle Questionnaire
Measured: Baseline, 2 months, 5 months 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2008 (estimated)
- Study startJul 2003
- Primary completionJan 2007
- Study completionMay 2008
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 Texas at AustinThe 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
- 177 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Alexa Stuifbergen, PhD, RN, Principal investigator, The University of Texas at Austin School of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00596674
- Sponsor's protocol ID
- 2002-08-0043
- Other IDs
- R01HD035047
- Status last verified
- Apr 2012
- First submitted
- 8 Jan 2008
- Last updated
- 25 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Promotion for Women With Fibromyalgia
- ClinicalTrials.gov ID
- NCT00596674
- Acronym / sponsor ID
- 2002-08-0043
- Conditions
- Fibromyalgia
- Keywords
- Women, Fibromyalgia Syndrome, Health Behaviors, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 177 participants (actual)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Jul 2003
- Primary completion
- Jan 2007 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 17 Jan 2008 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lifestyle Counts Intervention | Experimental | Behavioral: Lifestyle CountsA 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 comparator | Other: Attention Control8 weeks of general health classes followed by phone calls for 3 months |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Pregnancy
- Male
- Concurrent medical conditions (as judged by their physician) for which changes in diet and exercise would be contraindicated
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 Counts8 weeks of classes focused on health behavior change, individualized goal setting and 3 months of follow-up phone support | Behavioural | Lifestyle Counts Intervention |
| Attention Control8 weeks of classes on general health information topics followed by 3 months of phone calls to solicit questions | Other | Attention Countrol |
Primary outcome
SF36 Subscales
Time frame: Baseline, 2 months, 5 months and 8 months
2 secondary outcomes
Fibromyalgia Impact Questionnaire
Time frame: Baseline, 2 months, 5 months, 8 months
Health Behaviors - The Health Promoting Lifestyle Questionnaire
Time frame: Baseline, 2 months, 5 months 8 months
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 25 Apr 2012.
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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.
Alexa Stuifbergen, PhD, RN principal investigator
The University of Texas at Austin School of Nursing
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 Counts in people with Fibromyalgia, run by University of Texas at Austin 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 4 inclusion and 3 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 25 Apr 2012. 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. Some participants in this study may receive a placebo. 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?
SF36 Subscales (time frame: Baseline, 2 months, 5 months and 8 months). 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 25 Apr 2012.