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- Register voor klinische proeven in de VS.
- Klinische proef NCT00596674
Health Promotion for Women With Fibromyalgia
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Texas
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Austin, Texas, Verenigde Staten, 78701
- The University of Texas at Austin
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
---|---|
Experimenteel: Lifestyle Counts Intervention
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.
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8 weeks of classes focused on health behavior change, individualized goal setting and 3 months of follow-up phone support
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Placebo-vergelijker: Attention Countrol
8 weeks of general health classes followed by phone calls for 3 months
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8 weeks of classes on general health information topics followed by 3 months of phone calls to solicit questions
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
---|---|
SF36 Subscales
Tijdsspanne: Baseline, 2 months, 5 months and 8 months
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Baseline, 2 months, 5 months and 8 months
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Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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Fibromyalgia Impact Questionnaire
Tijdsspanne: Baseline, 2 months, 5 months, 8 months
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Baseline, 2 months, 5 months, 8 months
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Health Behaviors - The Health Promoting Lifestyle Questionnaire
Tijdsspanne: Baseline, 2 months, 5 months 8 months
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Baseline, 2 months, 5 months 8 months
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Alexa Stuifbergen, PhD, RN, The University of Texas at Austin School of Nursing
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 2002-08-0043
- R01HD035047 (Subsidie/contract van de Amerikaanse NIH)
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
Klinische onderzoeken op Lifestyle Counts
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University of WarwickUniversity of BirminghamVoltooid