Dementia
Conditions
Keywords
Dementia, Alzheimer
Brief summary
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.
Detailed description
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. The INSPIRE Study's primary goal is to demonstrate how targeted community relevant lifestyle interventions can reduce the risk of cognitive decline in all populations that are vulnerable to such outcomes. By addressing factors such as diet, physical activity, stress management, and social engagement, and management of vascular risk factors, the study aims to create a model for improving brain health that can be replicated in all communities. The study's findings will not only contribute to the scientific understanding of lifestyle-related cognitive health but also have the potential to inform public health strategies and policy decisions aimed at improving access to health resources and support. The long-term vision is to establish the Healthy Minds Initiative as a leader in brain health for all, with the INSPIRE Study serving as a blueprint for future community interventions.
Interventions
BEHAVIORALLifestyle Intervention
This arm involves interventions like health coaching, dietary changes, exercise programs, and other lifestyle modifications.
Participants in the Standard of Care Arm will receive basic educational materials focused on general cognitive and physical health maintenance.
Sponsors
Healthy Minds Initiative
American College of Lifestyle Medicine
Charles Drew University of Medicine and Science
University of California, Los Angeles
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)
Masking description
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.
Intervention model description
The INSPIRE Study is a randomized controlled trial (RCT) with 2,000 participants aged 55 and older. Participants will be randomly assigned to either an intervention group, receiving a personalized, lifestyle-based program with health coaching, or a control group, receiving standard health education materials. Both groups will undergo baseline and follow-up assessments, including cognitive tests and lifestyle evaluations. The study emphasizes community engagement and lifestyle interventions, aiming to provide insights into the impact of lifestyle changes on cognitive health and to inform public health strategies for dementia prevention in all populations.
Eligibility
Sex/Gender
ALL
Age
55 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Cognitive Function | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adherence to Lifestyle Interventions | Continuous, with key evaluations at 6 months and 12 months. | Measure adherence to prescribed diet and exercise changes through self-reported questionnaires and logs maintained by health coaches. |
Countries
United States
Contacts
CONTACTDean Sherzai, MD, PhD
CONTACTCaroline Segalla, BA
PRINCIPAL_INVESTIGATORDean Sherzai, MD, PhD
Healthy Minds Initiative
Outcome results
None listed