Health Promotion for Women With Fibromyalgia
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
Texas
-
Austin, Texas, États-Unis, 78701
- The University of Texas at Austin
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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.
|
8 weeks of classes focused on health behavior change, individualized goal setting and 3 months of follow-up phone support
|
|
Comparateur placebo: Attention Countrol
8 weeks of general health classes followed by phone calls for 3 months
|
8 weeks of classes on general health information topics followed by 3 months of phone calls to solicit questions
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
|
SF36 Subscales
Délai: Baseline, 2 months, 5 months and 8 months
|
Baseline, 2 months, 5 months and 8 months
|
Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
|
Fibromyalgia Impact Questionnaire
Délai: Baseline, 2 months, 5 months, 8 months
|
Baseline, 2 months, 5 months, 8 months
|
|
Health Behaviors - The Health Promoting Lifestyle Questionnaire
Délai: Baseline, 2 months, 5 months 8 months
|
Baseline, 2 months, 5 months 8 months
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Alexa Stuifbergen, PhD, RN, The University of Texas at Austin School of Nursing
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2002-08-0043
- R01HD035047 (Subvention/contrat des NIH des États-Unis)
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