Sedentary BehaviorNCT06362824
Promoting Physical Activity in Older Hispanic/Latino(a) Adults
A study testing De Pie Intervention and Active Comparison Group: Healthy Actions And Lifestyles To Avoid Dementia (HALT-AD) in people with Sedentary Behavior and Physical Inactivity, run by Kaiser Permanente at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 55 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Sedentary Behavior, Physical Inactivity, Alzheimer Disease, Protection Against
- What is being tested?
- De Pie Intervention and Active Comparison Group: Healthy Actions And Lifestyles To Avoid Dementia (HALT-AD)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 2 sitesUnited States
- Study dates
- 24 Sep 2024to 31 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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,
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- 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)
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of California San Diego
San Diego, California, 92093
Kaiser Permanente Washington
Seattle, Washington, 98101
About this study
Official title: 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 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).
Read the 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.
- Being tested
- De Pie Intervention, Active Comparison Group: Healthy Actions And Lifestyles To Avoid Dementia (HALT-AD)
- Medical subject headings
- Sedentary Behavior, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
De Pie InterventionBehavioural
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 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: Other: Active Comparison Group: Healthy Actions And Lifestyles To Avoid Dementia (HALT-AD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline to 12 weeks
Secondary outcomes (4)
Meet MIPA guidelines of 150 minutes physical activity per week
Time (minutes) spent being physical active during waking hours (mins/day, >1951 counts per minute) will be measured objectively by the ActiGraph worn for one week at Baseline and again after 12 weeks
Measured: Baseline to 12 weeks
Average daily sedentary time
mins/day; ≤99 counts per minute will be measured objectively by the ActiGraph worn for one week at baseline and again after 12 weeks.
Measured: Baseline to 12 weeks
Average daily light intensity physical activity (LPA)
mins/day; 100-1951 counts per minute will be measured objectively by the ActiGraph worn for one week at Baseline and again after 12 weeks
Measured: Baseline to 12 weeks
Average steps/day
Change in daily steps will be measured objectively by the ActiGraph worn for one week at Baseline and again after 12 weeks
Measured: Baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2024
- Study start24 Sep 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sedentary BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, San Diego
- Responsible party
- Sponsor
- Investigators
- Dori E Rosenberg, PhD, MPH, Principal investigator, Kaiser PermanenteZvinka Z Zlatar, PhD, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06362824
- Sponsor's protocol ID
- 2094138
- Status last verified
- Oct 2026
- First submitted
- 8 Apr 2024
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- De Pie y a Movernos Study: Promoting Physical Activity in Older Hispanic/Latino(a) Adults
- ClinicalTrials.gov ID
- NCT06362824
- Acronym / sponsor ID
- 2094138
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Collaborators
- University of California, San Diego
- Study start
- 24 Sep 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 12 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| De Pie Intervention | Experimental | Behavioral: De Pie InterventionThe 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. |
| HALT-AD Active Comparison Group | Active comparator | Other: Active Comparison Group: Healthy Actions And Lifestyles To Avoid Dementia (HALT-AD)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). |
Who may qualify
- Ages
- 55 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| De Pie InterventionParticipants 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. | Behavioural | De Pie Intervention |
| 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. | Other | HALT-AD Active Comparison Group |
Primary outcome
Change in Moderate Intensity Physical Activity (MIPA) minutes/day
Time frame: Baseline to 12 weeks
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
4 secondary outcomes
Meet MIPA guidelines of 150 minutes physical activity per week
Time frame: Baseline to 12 weeks
Average daily sedentary time
Time frame: Baseline to 12 weeks
Average daily light intensity physical activity (LPA)
Time frame: Baseline to 12 weeks
Average steps/day
Time frame: Baseline to 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dori E Rosenberg, PhD, MPH principal investigator
Kaiser Permanente
Zvinka Z Zlatar, PhD principal investigator
University of California, San Diego
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing De Pie Intervention and Active Comparison Group: Healthy Actions And Lifestyles To Avoid Dementia (HALT-AD) in people with Sedentary Behavior and Physical Inactivity, run by Kaiser Permanente at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Moderate Intensity Physical Activity (MIPA) minutes/day (time frame: Baseline to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.