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

NCT06362824 | Recruiting

• 1 other identifier: 2094138
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 2

Brief 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).

Conditions

Sedentary Behavior; Physical Inactivity; Alzheimer Disease, Protection Against

Outcome Measures

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

  Baseline to 12 weeks

Secondary Outcomes (4)

• Meet MIPA guidelines of 150 minutes physical activity per week

  Baseline to 12 weeks

• Average daily sedentary time

  Baseline to 12 weeks

• Average daily light intensity physical activity (LPA)

  Baseline to 12 weeks

• Average steps/day

  Baseline to 12 weeks

Study Arms (2)

De Pie Intervention

EXPERIMENTAL

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

HALT-AD Active Comparison Group

ACTIVE COMPARATOR

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

De Pie Intervention BEHAVIORAL

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.

De Pie Intervention

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

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.

HALT-AD Active Comparison Group

Eligibility Criteria

• Age: 55 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Kaiser Permanente: lead
• University of California, San Diego: collaborator

Study Sites (2)

University of California San Diego

San Diego, California, 92093, United States

RECRUITING

Kaiser Permanente Washington

Seattle, Washington, 98101, United States

NOT YET RECRUITING

MeSH Terms

Conditions

Sedentary Behavior; Alzheimer Disease

Condition Hierarchy (Ancestors)

Behavior; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Dori E Rosenberg, PhD, MPH

  Kaiser Permanente

  PRINCIPAL INVESTIGATOR

• Zvinka Z Zlatar, PhD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Julie B Cooper, MPA

CONTACT

206-287-2802; julie.b.cooper@kp.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2024
• First Posted: April 12, 2024
• Study Start: September 24, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): May 31, 2027
• Last Updated: April 8, 2026

Record last verified: 2026-04

Locations

US (2)