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

Kaiser Permanente

Status: Enrolling

Conditions: Physical Inactivity; Alzheimer Disease, Protection Against; Sedentary Behavior

Treatments: Behavioral: De Pie Intervention; Other: Active Comparison Group: Healthy Actions And Lifestyles To Avoid Dementia (HALT-AD)

Study type: Interventional

Funder types: Other

Identifiers

NCT06362824

2094138

Details and patient eligibility

About

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).

Full 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.

Enrollment: 130 estimated patients

Sex: All

Ages: 55 to 89 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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
• 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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130 participants in 2 patient groups

De Pie Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: De Pie Intervention

HALT-AD Active Comparison Group

Active Comparator group

Description:

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).

Treatment:

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