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Bevordering van fysieke activiteit bij oudere Spaanstalige/Latino(a) volwassenen

22 oktober 2026 bijgewerkt door: Kaiser Permanente

De Pie y a Movernos-studie: Bevordering van fysieke activiteit bij oudere Spaanstalige/Latino(a) volwassenen

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).

Studie Overzicht

Toestand

Actief, niet wervend

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

130

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Verenigde Staten
    • California
      • San Diego, California, Verenigde Staten, 92093
        • University of California San Diego
    • Washington
      • Seattle, Washington, Verenigde Staten, 98101
        • Kaiser Permanente Washington

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

55 jaar tot 89 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Preventie
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Dubbele

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Gedragsmatig: 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.
Actieve vergelijker: 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).
Ander: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in Moderate Intensity Physical Activity (MIPA) minutes/day
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Meet MIPA guidelines of 150 minutes physical activity per week
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Kaiser Permanente

Medewerkers

University of California, San Diego

Onderzoekers

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

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

24 september 2024

Primaire voltooiing (Geschat)

31 december 2026

Studie voltooiing (Geschat)

31 mei 2027

Studieregistratiedata

Eerst ingediend

8 april 2024

Eerst ingediend dat voldeed aan de QC-criteria

8 april 2024

Eerst geplaatst (Werkelijk)

12 april 2024

Updates van studierecords

Laatste update geplaatst (Werkelijk)

26 oktober 2026

Laatste update ingediend die voldeed aan QC-criteria

22 oktober 2026

Laatst geverifieerd

1 oktober 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 2094138

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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