Intervention Strategies for Preserving Intellectual Resilience and Engagement
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 2,000
- 试验地点
- 2
- 主要终点
- Change in Cognitive Function
研究概览
简要总结
The INSPIRE-Faith Study, initiated by the Healthy Minds Initiative, is a community-based research project aimed at demonstrating the impact of lifestyle factors on cognitive health and the prevention of dementia. Conducted in collaboration with the American College of Lifestyle Medicine, Charles Drew University, UCLA, Stanford University and Crenshaw Christian Center, this study focuses on all communities that are affected by lifestyle-dependent diseases. The study involves 2,000 participants aged 55 and older and aims to implement targeted community relevant interventions to enhance cognitive function and overall brain health.
详细描述
The INSPIRE-Faith Study, led by the Healthy Minds Initiative, is a groundbreaking community-based research project aimed at exploring the relationship between lifestyle factors and cognitive health, with an emphasis on nutrition and dietary intervention, to prevent dementia and cognitive impairment in communities. This study will take start in South Los Angeles, California, a region characterized by the prevalence of lifestyle-dependent diseases but will expand into all of California.
The study, slated to begin in January/February 2025, will involve 2,000 participants aged 55 and older, recruited through community outreach, health education programs, and referrals from local healthcare providers. Participants will undergo a comprehensive initial assessment, including evaluations of medical history, cognitive function, lifestyle habits, and access to health resources.
Participants will be randomized into two groups: an intervention group and a control group. The intervention group will receive personalized guidance from health coaches, participate in an online community forum designed to teach about nutrition and lifestyle risk factor management, and have access to tailored exercise programs, educational materials, and other resources designed to promote cognitive health. The control group will receive standard-of-care educational material and monthly communications aimed at maintaining or improving health. Both groups will undergo baseline assessments and periodic evaluations throughout the study to measure the impact of the interventions on cognitive health.
The Inspire-Faith Study employs a randomized controlled crossover design to promote equity, maximize participant benefit, and enhance retention. Participants will be randomized to either the Guided Lifestyle Intervention Group or the Independent (Standard Health Education) Group for the first 6 months. At the 6-month midpoint, study arms will cross over, such that participants initially assigned to the control condition will receive the guided intervention, and participants initially receiving the guided intervention will transition to the independent condition.
The study is designed to leverage community partnerships with organizations such as the American College of Lifestyle Medicine, Charles Drew University, UCLA, Stanford University and Crenshaw Christian Center. These partnerships provide the necessary infrastructure, expertise, and community trust to ensure the study's success.
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, Care Provider)
盲法说明
The INSPIRE Study employs a single-blind design, where participants are unaware of their group assignment (intervention or control) to minimize bias in reporting and behavior. However, the investigators and study staff administering the interventions and conducting assessments are not blinded due to the nature of the intervention, which requires direct interaction and coaching. To further reduce potential bias, outcome assessors involved in data analysis will remain blinded to the group assignments until after the primary data analysis is completed.
入排标准
- 年龄范围
- 55 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age: Participants must be 55 years of age or older.
- •Ethnicity: Focused on African American individuals, but not exclusive.
- •Cognitive Status: Participants must have normal cognitive status, mild cognitive impairment (MCI), or subjective cognitive impairment (SCI).
- •Language: Participants must be fluent in English.
- •Location: Must reside in the Crenshaw, California area or* be able to attend study-related activities in this location. *online access is available for those not in this area.
- •Willingness to Participate: Participants must be willing to adhere to the study protocol, including attending assessments, participating in interventions, and completing questionnaires.
排除标准
- •Cognitive Decline: Diagnosis of dementia or severe cognitive impairment that would interfere with the ability to participate in the study.
- •Physical Limitations: Any physical or medical condition that would preclude participation in the lifestyle interventions (e.g., severe mobility issues).
- •Recent Cancer Diagnosis: Diagnosis of cancer within the last three years, excluding stable cases of basal cell or squamous cell carcinoma of the skin, or stable prostate cancer.
- •Pregnancy: Current pregnancy or planning to become pregnant during the study period.
- •Mental Health: Diagnosis of severe psychiatric disorders such as schizophrenia or bipolar disorder that might interfere with participation.
- •Substance Abuse: Current substance abuse or dependency that could impact participation.
- •Hearing Impairment: Uncorrected hearing loss that would limit the ability to communicate and participate in the study.
- •Non-English Speaking: Inability to participate in English-language oral and written cognitive assessments.
- •Participation in Another Study: Currently enrolled in another clinical trial that could interfere with the INSPIRE Study.
- •Life expectancy less than 3 years
- •Unwillingness to share medical and laboratory information.
研究组 & 干预措施
Lifestyle Intervention
This arm involves an active intervention with health coaching and lifestyle changes.
干预措施: Lifestyle Intervention (Behavioral)
Standard Health Education
This arm receives a standard educational approach without the intensive intervention.
干预措施: Standard Health Education (Other)
结局指标
主要结局
Change in Cognitive Function
时间窗: 6 months, 1 year and 3 years
Change in global composite score from baseline, as measured by the TABCAT (Tablet-based Cognitive Assessment Tool) composite score, at the designated endpoint (e.g., 6 months, 1 year, and 3 years). This composite score reflects core domains of cognition-including memory, executive function, language, and processing speed-captured through standardized TABCAT assessments.
次要结局
- Adherence to Lifestyle Interventions(Continuous, with key evaluations at 6 months and 12 months.)