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Promouvoir l'activité physique chez les adultes hispaniques/latino(a) plus âgés

22 octobre 2026 mis à jour par: Kaiser Permanente

Étude De Pie y a Movernos : Promouvoir l'activité physique chez les adultes hispaniques/latino(a) plus âgés

In this randomized controlled trial, study staff will randomize 130 Hispanic/Latino adults without dementia and over age 55 from Southern California and from Kaiser Permanente Washington (State) to either the culturally adapted De Pie physical activity intervention or an active comparison program focusing on general brain health topics. The purpose of this study is to determine if 12 weeks of the culturally adapted and fully remote De Pie y a Movernos intervention improves self-efficacy, habit strength, social support, and enjoyment for physical activity (PA), thus promoting adherence to moderate-intensity physical activity (MIPA) guidelines (150 minutes/week).

Aperçu de l'étude

Statut

Actif, ne recrute pas

Les conditions

Intervention / Traitement

Description détaillée

Building on the cultural adaptation of our preliminary R61 De Pie pilot study, study staff will randomize 130 Hispanic/Latino adults without dementia and over age 55 from Southern California and from Kaiser Permanente Washington to either the culturally adapted De Pie physical activity intervention or an active comparison program, Healthy Actions and Lifestyles to Avoid Dementia (HALT-AD), focusing on general brain health topics. The investigators will determine if De Pie improves physical activity (Aim 1) and psychosocial mediators (self-efficacy, habit strength, social support, and enjoyment for physical activity, [PA]), thus promoting adherence to moderate-intensity physical activity (MIPA) guidelines (150 minutes/week; Aim 2). The intervention period lasts 12 weeks.

The investigators target middle-aged and older Hispanic/Latino adults that are under-studied and have a higher risk of Alzheimer's disease and related dementias (ADRD), compared to non-Hispanic White older adults. Study staff employ a community engaged and collaborative approach to culturally adaptive the intervention framework and a staircase intervention approach designed to build self-efficacy, PA habit strength, social support, and PA enjoyment. Results will inform culturally adapted, theory-based approaches to prevent ADRD in the Hispanic/Latino community.

Type d'étude

Interventionnel

Inscription (Estimé)

130

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • États-Unis
    • California
      • San Diego, California, États-Unis, 92093
        • University of California San Diego
    • Washington
      • Seattle, Washington, États-Unis, 98101
        • Kaiser Permanente Washington

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

55 ans à 89 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Oui

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

  • be 55-89 and self-identify as Hispanic/Latino(a)
  • able to participate for up to 20 weeks in the study
  • willing to be randomized to the intervention or active comparison program
  • willing to follow study procedures depending on program assignment
  • available M-F for study phone calls between 8am-5pm
  • able to walk one block unassisted,
  • able to speak and can read Spanish or English,
  • have a smartphone (85% of the Hispanic/Latino(a) population has a smartphone)
  • willing to wear an ActiGraph for up to 2 weeks, twice during the course of the study
  • willing to complete study questionnaires via weblink, paper, or phone call
  • have an email address and be willing to share it with the team
  • have a US mailing address where they receive mail regularly (confirmed in pre-screen)

Exclusion criteria are as follows:

  • score less than or equal to 4 on the Six-Item Screener (Callahan et al., 2002)
  • unable to hear phone conversation, even with a hearing aid
  • planned surgeries or travel that would interfere with participation
  • had a fall in the last year that resulted in hospitalization
  • had a cancer diagnosis that requires treatment in the past year (other than skin cancer)
  • had a diagnosis of heart attack or irregular heart beat (arrythmia) in the past year
  • been advised recently by their doctor to avoid physical activity
  • does not want to share cognitive health information collected during the study with researchers at UCSD
  • unwilling to share their email address
  • unwilling to obtain an email address if they do not already have one
  • currently participating in another institution's physical activity study

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: La prévention
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Double

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: De Pie Intervention

The De Pie intervention program receives a sedentary behavior reduction and physical activity promotion intervention centered on two steps: Step 1) reduce sitting time and move more throughout the day; Step 2) if cleared by a safety assessment and blood pressure check, participants can work towards adding structured bouts of exercise into their day.
Comportemental: De Pie Intervention

Participants are guided by a health coach trained in motivational interviewing through 6 biweekly phone sessions. Each session involves reviewing goals and problem-solving barriers from the prior 2 weeks experience; covering a topic related to Step 1 goals (or Step 2 goals if they pass the safety assessment) such as how to enjoy movement, social support, and using your surroundings; and setting goals and an action plan for the following two weeks.
Comparateur actif: HALT-AD Active Comparison Group

Those randomized to HALT-AD (Healthy Actions and Lifestyles to Avoid Dementia) will receive one phone call to introduce them to preventing cognitive decline through various lifestyle behaviors (e.g. stress reduction, healthy diet, healthy sleep) other than physical activity. They will be encouraged by the Health Coach upon randomization to complete one module approximately every week (there are 10 modules in total).
Autre: Active Comparison Group: Healthy Actions And Lifestyles To Avoid Dementia (HALT-AD)

Those in the active comparison program will receive no additional health coaching sessions. They will work through the HALT-AD content at their own pace, setting goals in the online platform as they go.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Change in Moderate Intensity Physical Activity (MIPA) minutes/day
Délai: Baseline to 12 weeks

Time (minutes) spent being physically active during waking hours will be measured objectively by the ActiGraph worn for one week at Baseline and again after 12 weeks
Baseline to 12 weeks

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Meet MIPA guidelines of 150 minutes physical activity per week
Délai: Baseline to 12 weeks

Time (minutes) spent being physical active during waking hours (mins/day, >1951 counts per minute) will be measured objectively by the ActiGraph worn for one week at Baseline and again after 12 weeks
Baseline to 12 weeks
Average daily sedentary time
Délai: Baseline to 12 weeks

mins/day; ≤99 counts per minute will be measured objectively by the ActiGraph worn for one week at baseline and again after 12 weeks.
Baseline to 12 weeks
Average daily light intensity physical activity (LPA)
Délai: Baseline to 12 weeks

mins/day; 100-1951 counts per minute will be measured objectively by the ActiGraph worn for one week at Baseline and again after 12 weeks
Baseline to 12 weeks
Average steps/day
Délai: Baseline to 12 weeks

Change in daily steps will be measured objectively by the ActiGraph worn for one week at Baseline and again after 12 weeks
Baseline to 12 weeks

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Kaiser Permanente

Collaborateurs

University of California, San Diego

Les enquêteurs

  • Chercheur principal: Zvinka Z Zlatar, PhD, University of California, San Diego
  • Chercheur principal: Dori E Rosenberg, PhD, MPH, Kaiser Permanente

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

24 septembre 2024

Achèvement primaire (Estimé)

31 décembre 2026

Achèvement de l'étude (Estimé)

31 mai 2027

Dates d'inscription aux études

Première soumission

8 avril 2024

Première soumission répondant aux critères de contrôle qualité

8 avril 2024

Première publication (Réel)

12 avril 2024

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

26 octobre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

22 octobre 2026

Dernière vérification

1 octobre 2026

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 2094138

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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