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

De Pie y a Movernos Study: Promoting Physical Activity in Older Hispanic/Latino(a) Adults

In this randomized controlled trial, study staff will randomize 130 Hispanic/Latino adults without dementia and over age 55 from Southern California 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).

Study Overview

• Status: Not yet recruiting
• Conditions: Sedentary Behavior; Physical Inactivity; Alzheimer Disease, Protection Against
• Intervention / Treatment: Behavioral: De Pie Intervention; Other: Active Comparison Group: Healthy Actions And Lifestyles To Avoid Dementia (HALT-AD)

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 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.

• Study Type: Interventional
• Enrollment (Estimated): 130
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Julie B Cooper, MPA; Phone Number: 206-287-2802; Email: julie.b.cooper@kp.org

Study Locations

• United States
  • California
    • San Diego, California, United States, 92093
      • University of California San Diego
      • Contact: Zvinka Z Zlatar, PhD; Email: zzlatar@health.ucsd.edu
      • Principal Investigator: Zvinka Z Zlatar, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

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

Exclusion criteria are as follows:

• score less than or equal to 4 on the Six-Item Screener
• unable to hear phone conversation, even with a hearing aid
• planned surgeries or travel that would interfere with participation
• spend more than 90 minutes a week doing physical activity (going for a walk, running, swimming, bicycling, etc)
• work in a physically demanding job that requires them to be on their feet for most of the day
• spend less than 6 hours per day sitting or lying down (not counting sleeping time at night)
• 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 by their doctor to avoid physical activity
• unwilling to share their email address
• unwilling to obtain an email address if they do not already have one

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; 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.
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); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Baseline to 12 weeks

Collaborators and Investigators

• Sponsor: Kaiser Permanente
• Collaborators: University of California, San Diego
• Investigators: Principal Investigator: Zvinka Z Zlatar, PhD, University of California, San Diego; Principal Investigator: Dori E Rosenberg, PhD, MPH, Kaiser Permanente

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): September 30, 2029

Study Registration Dates

• First Submitted: April 8, 2024
• First Submitted That Met QC Criteria: April 8, 2024
• First Posted (Actual): April 12, 2024

Study Record Updates

• Last Update Posted (Estimated): April 15, 2024
• Last Update Submitted That Met QC Criteria: April 11, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Alzheimer Disease
• Other Study ID Numbers: 2094138

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No