Clinical trial NCT06362824: Promoting Physical Activity in Older Hispanic/Latino(a) Adults
Official title: De Pie y a Movernos Study: Promoting Physical Activity in Older Hispanic/Latino(a) Adults
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sedentary Behavior
Physical Inactivity
Alzheimer Disease, Protection Against
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
Collaborators: name: University of California, San Diego
First posted: 2024-04-12
Enrollment: 130
Sex: ALL
Minimum age (years): 55
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Moderate Intensity Physical Activity (MIPA) minutes/day
timeFrame: Baseline to 12 weeks
Secondary outcomes:
measure: Meet MIPA guidelines of 150 minutes physical activity per week
timeFrame: Baseline to 12 weeks
Other outcomes:
Locations:
city: San Diego
country: United States
facility: University of California San Diego
state: California
city: Seattle
country: United States
facility: Kaiser Permanente Washington
state: Washington
Study officials:
affiliation: Kaiser Permanente
name: Dori E Rosenberg, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Diego
name: Zvinka Z Zlatar, PhD
role: PRINCIPAL_INVESTIGATOR
References: