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Active, not recruitingNCT06362824Updated Sep 21, 2026

Promoting Physical Activity in Older Hispanic/Latino(a) Adults

An interventional study of De Pie Intervention and Active Comparison Group: Healthy Actions And Lifestyles To Avoid Dementia (HALT-AD) in Sedentary Behavior, Physical Inactivity and Alzheimer Disease, Protection Against, sponsored by Kaiser Permanente. Active, not recruiting at 2 sites in United States. Open to participants aged 55 Years to 89 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-21.

Sponsored by Kaiser Permanente · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
130
Allocation
Randomized
Ages
55 Years to 89 Years
Sex
All
01

Study summary

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).

Read the detailed description

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.

02

Conditions studied

  • Sedentary Behavior
  • Physical Inactivity
  • Alzheimer Disease, Protection Against
03

In context

Sedentary Behavior

332 studies on the registry are indexed under Sedentary Behavior; 155 are open to participants now.

This study's planned enrollment of 130 is above the median of 70 across 287 interventional studies indexed under Sedentary Behavior.

Browse Sedentary Behavior studies →

Lead sponsor

Kaiser Permanente is the lead sponsor of 385 studies on the registry; 41 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 3 (50%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
55 Years to 89 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
130 participants (estimated)

Study arms

  • Experimental
    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.

    Behavioral: De Pie Intervention

  • Active comparator
    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).

    Other: Active Comparison Group: Healthy Actions And Lifestyles To Avoid Dementia (HALT-AD)

Interventions

  • BehavioralDe 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.

  • OtherActive 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.

06

What researchers measure

Primary outcomes

  1. Change in Moderate Intensity Physical Activity (MIPA) minutes/day

    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

    Time frame: Baseline to 12 weeks

Secondary outcomes

  1. Meet MIPA guidelines of 150 minutes physical activity per week

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

    Time frame: Baseline to 12 weeks

  2. Average daily sedentary time

    mins/day; ≤18 counts per 15s will be measured objectively by the ActiGraph worn for one week at baseline and again after 12 weeks.

    Time frame: Baseline to 12 weeks

  3. Average daily light intensity physical activity (LPA)

    mins/day; 19-518 counts per 15s will be measured objectively by the ActiGraph worn for one week at Baseline and again after 12 weeks

    Time frame: Baseline to 12 weeks

  4. Average steps/day

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

    Time frame: Baseline to 12 weeks

07

Study locations

2 sites
  • University of California San Diego
    San Diego, California 92093, United States
  • Kaiser Permanente Washington
    Seattle, Washington 98101, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 21, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06362824
Lead sponsor
Kaiser Permanente
Collaborators
University of California, San Diego
Responsible party
Sponsor
First posted
Apr 12, 2024
Start date
Sep 24, 2024
Primary completion
Dec 31, 2026 (estimated)
Completion
May 31, 2027 (estimated)
Last update
Sep 21, 2026

Study contacts

Dori E Rosenberg, PhD, MPH
principal investigator · Kaiser Permanente
Zvinka Z Zlatar, PhD
principal investigator · University of California, San Diego

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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