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L'essai clinique NCT05566873 (WHISH EnCore) pour Inactivité physique est en recrutement. Consultez la vue en carte du Radar des Essais Cliniques et les outils de découverte par IA pour tous les détails, ou posez vos questions ici. | ||
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Université StanfordTesting Multi-Level Remote Physical Activity Interventions in a National Sample of Older Women: The WHISH EnCore Trial
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L'étude clinique NCT05566873 (WHISH EnCore) est un essai interventionnel pour Inactivité physique. Son statut actuel est : en recrutement. L'étude a débuté le 9 janvier 2024 et vise à recruter 232 participants. Dirigé par l'Université Stanford, l'essai devrait être terminé d'ici le 28 février 2027. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 27 avril 2025.
Résumé succinct
While older women are disproportionately affected by chronic diseases and conditions associated with aging, including both physical and cognitive impairments, that can be alleviated or delayed by regular physical activity, few physical activity programs have been developed specifically with their needs in mind. This research aims to evaluate, in insufficiently active older women from the national WHISH pragmatic trial, the effects of a technology-driven "citizen science" approach to environmental physical activity barriers called Our Voice plus the ongoing "light-touch" remote physical activity educational program, compared to the "light-touch" remote physical activity educational program plus a control educational intervention that creates awareness around human and planetary health. This study will add important information on the benefits and trade-offs of combining these remotely delivered and practical behavioral health approaches to promote physical and cognitive health for the fast-expanding demographic group of U.S. older women.
Description détaillée
Older women are disproportionately impacted by a range of chronic diseases and conditions, such as cognitive impairments, that can be alleviated by regular physical activity (PA), including walking; yet they are the most inactive segment of the US population. This study's primary aim is to enhance the efficacy of a "light-touch", remotely delivered PA educational intervention for older women by testing the added impacts of an innovative, remotely delivered citizen science program to identify and address local environmental barriers to walking and other PA, called Our Voice (OV). The "light-touch" PA educational program (Encore) has been delivered since 2015 to >23,000 women >70 years that have been participating in the U.S.-wide Women's Health Initiative Strong and Healthy (WHISH) pragmatic PA trial. The study's hypothesis is that women receiving Encore+OV will show higher 12-month PA levels than women receiving Encore plus the control educational program. Additional questions include changes in cognitive function and sedentary behavior and exploring the relative costs of the two programs for PA change.
Titre officiel
Testing Multi-Level Remote Physical Activity Interventions in a National Sample of Older Women: The WHISH EnCore Trial
Conditions
Inactivité physiqueAutres identifiants de l'essai
- WHISH EnCore
- 62096
- R01AG071490 (Subvention/contrat NIH (É.-U.))
Numéro NCT
Date de début (réel)
2024-01-09
Dernière mise à jour publiée
2025-04-27
Date de fin (estimée)
2027-02-28
Inscription (estimée)
232
Type d'essai
Interventionnel
PHASE
N/A
Statut
En recrutement
Objectif principal
Prévention
Plan d'attribution
Randomisé
Modèle d'intervention
Parallèle
Masquage
Simple aveugle
Bras / Interventions
| Groupe de participants/Bras | Intervention/Traitement |
|---|---|
Comparateur actifPA Education plus human and planetary health information Participants will continue to receive the remote "light touch" physical activity education program that they have been receiving for the past several years along with additional remote health education information to control for nonspecific factors (staff attention, participant time). | PA Education Plus Human and Planetary Health Information One year of continuing person-level physical activity promotion and health-related information delivered primarily by mail, email, and through online scientific video presentations and exploration of freely available citizen science mobile applications |
ExpérimentalPA Education plus Our Voice citizen science Participants will receive the remote "light touch" physical activity education program in combination with the remote Our Voice citizen science program aimed at identifying and addressing physical and social environmental barriers to and enablers of regular physical activity. | PA Education Plus Our Voice Citizen Science One year of continuing person-level physical activity promotion and health-related information delivered primarily by mail and email, plus participatory citizen science activities involving neighborhood audits of the walking environment using a mobile app and remote group discussion and problem-solving around physical activity barriers |
Critère principal d'évaluation
Critère secondaire d'évaluation
| Critères d'évaluation | Description de critères | Période |
|---|---|---|
Mean number of steps per day as measured by step counter | Participants will wear an Accusplit pedometer to record on the WHISH study website data entry tracking system their number of steps/day. Higher numbers of steps per day is considered a better outcome. | 12 months |
| Critères d'évaluation | Description de critères | Période |
|---|---|---|
Weekly walking minutes | Self-report using the Community Healthy Activities Model Program for Seniors (CHAMPS) Physical Activity Questionnaire. CHAMPS is a self-report physical activity questionnaire that assesses weekly frequency and duration of various activities typically undertaken by midlife and older adults over the prior 4-week period (for example, self-reported walking for errands, for leisure, up hills, brisk walking). The measure has been shown to have good test-retest reliability (stability) and construct and concurrent validity, and has been shown to be sensitive to change in a variety of adult populations. It has seven frequency categories (from less than 1 hour a week to 9 or more hours per week). The minimum value (walking minutes) is 0 and there is no set maximum value. The national recommendation is for 150 minutes per week. Higher numbers on this measure are considered a better outcome. | 12 months |
Telephone Interview for Cognitive Status-modified (TICSm) | The 16-item (50-point) TICSm, which is the most widely used telephone cognitive assessment tools for older populations, and has been shown to have excellent validity and reliability in diverse groups of older adults. It correlates well with comprehensive neuropsychological assessments, is less constrained by ceiling effects than the Mini Mental State Examination (MMSE), and has been shown to be sensitive to change. A higher score on this measure is considered a better outcome. | 12 months |
Self-report Sedentary Behavior Questionnaire | This 7-item 1-week recall questionnaire has been shown to have good test-retest reliability and validity, and has been shown to be sensitive to change with intervention. A higher score is considered a worse outcome. | 12 months |
Critères d'éligibilité
Âges éligibles
Adulte âgé
Âge minimum
66 Years
Sexes éligibles
Femme
Accepte les volontaires en bonne santé
Oui
- Is insufficiently physically active based on National Guidelines;
- Can engage in moderate forms of walking in and around their neighborhoods;
- Owns and can use a smartphone;
- Willing to wear the study pedometer;
- No plans to move from the area over the 1 year study period;
- Willing to be randomized and engage in study assessments;
- Not currently living in a nursing home or with a dementia diagnosis or other medical condition that would preclude moderate forms of physical activity outside the home or study participation.
Université Stanford674 essais cliniques actifs à explorerNational Institute on Aging (NIA)Partie responsable de l'essai
Abby C King, Investigateur principal, Professor of Epidemiology and Population Health and of Medicine, Stanford University
Aucune donnée de contact disponible
1 Centres de l'essai dans 1 pays
California
Stanford University School of Medicine, Stanford, California, 94305, United States
Maria I Campero, Contact, 408-507-1852, [email protected]
Abby C King, Ph.D, Contact
En recrutement