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临床试验/NCT07018830
NCT07018830已完成不适用

Multicomponent Program for Addressing Cognition in Rural Communities

Pennington Biomedical Research Center2 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2025年4月22日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
11
试验地点
2
主要终点
Study feasibility

研究概览

简要总结

The study is designed to develop and evaluate a multicomponent intervention program among older rural-residing and African American residents with a long-term goal of reducing risk factors for Alzheimer's disease. The motivation for this study is that previous non-pharmacological (e.g. exercise diet, social engagement) interventions have improved cognitive function in older adults with and without cognitive impairments, but these studies were largely conducted without substantial representation from residents living in rural communities or African Americans. Due to geographic, sociocultural, and environmental differences between rural residents, African Americans and other populations, it is unclear whether positive findings from previous interventions will translate to rural residents or African American individuals.

详细描述

It is estimated that just over 5 million Americans are currently living with Alzheimer's Disease (AD) , and that number will rise to approximately 9 million by 2050. Rural areas were shown to have 1.4 - 1.7 times higher risk of developing dementia compared to urban areas and risk was shown to be increasing in comparison to urban areas. Risk factors in rural populations include age, lower levels of education, less access to health care, and higher rates of chronic disease. The prevalence of AD among African Americans is also elevated as it is approximately double that of non-Hispanic white Americans and older African Americans may be as much as 64% more likely to develop AD compared to non-Hispanic white Americans. Some contributors to AD are similar across rural residence and African Americans, including limited health care access, lower levels of trust in physicians, limited transportation, and built environmental issues. However, to date, there are few studies that have engaged in intervention work to address reduction of AD risk factors in older adults residing in rural communities. This is particularly true for older African Americans who may face increased barriers. Therefore, there is a need to conduct more AD prevention interventions in rural communities and especially those with large proportions of African Americans.

A large literature suggests that modifiable lifestyle behaviors are associated with the risk of developing AD. For example, both cross-sectional and longitudinal studies show that lower levels of physical activity and poorer dietary intake are associated with higher risk of developing AD. African Americans have low levels of physical activity and poor dietary quality compared to corresponding non-Hispanic white Americans. Studies in cohorts with predominantly low African American representation have shown that increasing physical activity, improving dietary intake, and engaging in cognitive training, individually, have all increased cognitive test scores across multiple domains. In addition, recent data (again from predominantly white cohorts) suggests that simultaneously changing multiple of these lifestyle behaviors at the same time may engage multiple, possibly synergistic neuroprotective mechanisms and thereby maximize neuroprotective benefits.

Multicomponent interventions, or non-pharmacological interventions that address several behaviors simultaneously (e.g. physical activity, diet, cognitive training, sleep) have been shown to be effective in improving cognitive function in older adults. Recently, the two-year Finnish Geriatric Intervention study to Prevent Cognitive Impairment and Disability (FINGER) trial intervened on physical activity, diet, cognitive training, and cardiometabolic health management simultaneously; those in the intervention had significant improvements in global cognitive function, executive functioning, and processing speed, compared to a group receiving usual health care. The FINGER results were so impressive that a worldwide network of FINGER replication studies have been engaged, including the POINTER study in the United States. However, to our knowledge, none of these multicomponent studies have included a large number of rural residents or African Americans.

We will develop a multicomponent intervention specifically tailored to older adults living in rural communities, and recruit at least 20, with a maximum of 40, adults into it. The 12 session intervention will consist of group-based lifestyle change sessions at a facility determined by the community. Cognitive functioning will be assessed to determine the brain effects of the intervention in this understudied population.

Specific Aim 1: To determine if a multicomponent intervention is feasible to deliver in older rural-residing adults. Hypothesis 1: We hypothesize that the intervention will be feasible to deliver. Feasibility will be assessed through recruitment, retention, attendance, and satisfaction ratings.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • > 60 years of age
  • reside in a rural city
  • not cognitively impaired
  • physically capable of exercise
  • willing to attend group sessions
  • plan to live in the study area for the next 6 months
  • willing to allow researchers to use data for research purposes after study participation is completed
  • free of conditions that would make regular exercise unsafe as deemed by the medical investigator
  • report at least two of the following: a) no regular physical activity, b) not consuming the Mediterranean diet, 3) sleep < 6 hours per night, 4) current diagnosis of hypertension, diabetes, or obesity (by physician diagnosis or medication), 5) high school education or less, 6) history of depression.

排除标准

  • unable or unwilling to give informed consent
  • are cognitively impaired (MMSE score of ≤ 18)
  • have sleep apnea
  • have uncontrolled hypertension (systolic blood pressure > 200 mmHg and/or diastolic blood pressure > 110 mmHg).
  • have had a hip fracture, hip or knee replacement, or spinal surgery in the past 6 months
  • have had a myocardial infarction, major heart surgery (i.e., valve replacement or bypass surgery), stroke, deep vein thrombosis or pulmonary embolus in the past 6 months
  • are undergoing cardiopulmonary rehabilitation
  • are currently enrolled in another randomized trial involving lifestyle or pharmaceutical interventions
  • have another member of the household that is a participant in the study
  • have plans to relocate out of the study area within the next 6 months
  • have uncontrolled diabetes that in the judgment of the MI may interfere with study participation
  • have other medical, psychiatric, or behavioral factors that in the judgment of the Principal or Medical Investigator may interfere with study participation or the ability to follow the intervention protocol

结局指标

主要结局

Study feasibility

时间窗: 3 months

Feasibility measures the likelihood of success of the study. It will be measured by a composite of 1) recruitment, 2) attendance, 3) retention, and 4) satisfaction.

次要结局

  • Mini-mental state exam(3 months)
  • Everyday Cognition Scale(3 months)
  • Wide Range Achievement Test - Reading Subtest(3 months)
  • Auditory Verbal Learning Test(3 months)
  • Cultural Consensus Modeling(3 months)
  • Mediterranean diet screener(3 months)
  • Perceived Sleep Quality Index(3 months)
  • Short Physical Performance Battery(3 months)
  • Height(3 months)
  • Physical Activity Readiness Questionnaire(3 months)
  • Blood Pressure(3 months)
  • Health Related Quality of Life(3 months)
  • The Food Noise Questionnaire(3 months)
  • Lubben Social Network Scale(3 months)
  • Community Healthy Activities Model Program for Seniors(3 months)
  • Weight(3 months)
  • Treatment satisfaction(3 months)
  • Geriatric Depression Scale(3 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Robert L. Newton, Jr.

Professor

Pennington Biomedical Research Center

研究点 (2)

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