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

Physical Inactivity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06362824
• Other study ID #: 2094138
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2024
• Est. completion date: September 30, 2029

Study information

• Verified date: April 2024
• Source: Kaiser Permanente
• Contact: Julie B Cooper, MPA
• Phone: 206-287-2802
• Email: julie.b.cooper[@]kp.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 130
• Est. completion date: September 30, 2029
• Est. primary completion date: September 30, 2028
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.

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.

Locations

Country	Name	City	State
United States	University of California San Diego	San Diego	California

Sponsors (2)

Lead Sponsor	Collaborator
Kaiser Permanente	University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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