此页面是自动翻译的，不保证翻译的准确性。请参阅 英文版 对于源文本。

促进老年西班牙裔/拉丁裔(a) 成年人的身体活动

2026年10月22日 更新者：Kaiser Permanente

De Pie y a Movernos 研究：促进老年西班牙裔/拉丁裔(a) 成年人的身体活动

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).

研究概览

地位

主动，不招人

条件

干预/治疗

详细说明

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.

研究类型

介入性

注册 (估计的)

130

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 美国
    • California
      • San Diego、California、美国、92093
        • University of California San Diego
    • Washington
      • Seattle、Washington、美国、98101
        • Kaiser Permanente Washington

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

55年 至 89年 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

全部

描述

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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：预防
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：双倍的

武器和干预

参与者组/臂
干预/治疗
实验性的：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.
行为的：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.
有源比较器：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).
其他：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.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Change in Moderate Intensity Physical Activity (MIPA) minutes/day
大体时间：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
Baseline to 12 weeks

次要结果测量

结果测量
措施说明
大体时间
Meet MIPA guidelines of 150 minutes physical activity per week
大体时间：Baseline to 12 weeks

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
Baseline to 12 weeks
Average daily sedentary time
大体时间：Baseline to 12 weeks

mins/day; ≤99 counts per minute will be measured objectively by the ActiGraph worn for one week at baseline and again after 12 weeks.
Baseline to 12 weeks
Average daily light intensity physical activity (LPA)
大体时间：Baseline to 12 weeks

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
Baseline to 12 weeks
Average steps/day
大体时间：Baseline to 12 weeks

Change in daily steps will be measured objectively by the ActiGraph worn for one week at Baseline and again after 12 weeks
Baseline to 12 weeks

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Kaiser Permanente

合作者

University of California, San Diego

调查人员

  • 首席研究员：Zvinka Z Zlatar, PhD、University of California, San Diego
  • 首席研究员：Dori E Rosenberg, PhD, MPH、Kaiser Permanente

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2024年9月24日

初级完成 (估计的)

2026年12月31日

研究完成 (估计的)

2027年5月31日

研究注册日期

首次提交

2024年4月8日

首先提交符合 QC 标准的

2024年4月8日

首次发布 (实际的)

2024年4月12日

研究记录更新

最后更新发布 (实际的)

2026年10月26日

上次提交的符合 QC 标准的更新

2026年10月22日

最后验证

2026年10月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • 2094138

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

订阅