De Pie y a Movernos Study: Promoting Physical Activity in Older Hispanic/Latino(a) Adults
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 130
- 试验地点
- 6
- 主要终点
- Change in Moderate Intensity Physical Activity (MIPA) minutes/day
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 55 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
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).
干预措施: Active Comparison Group: Healthy Actions And Lifestyles To Avoid Dementia (HALT-AD) (Other)
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.
干预措施: De Pie Intervention (Behavioral)
结局指标
主要结局
Change in Moderate Intensity Physical Activity (MIPA) minutes/day
时间窗: 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
次要结局
- Meet MIPA guidelines of 150 minutes physical activity per week(Baseline to 12 weeks)
- Meet MIPA guidelines of 150 minutes physical activity per week(Baseline to 12 weeks)
- Average daily sedentary time(Baseline to 12 weeks)
- Average daily light intensity physical activity (LPA)(Baseline to 12 weeks)
- Average steps/day(Baseline to 12 weeks)