What this study is
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.
What's being tested
- Lifestyle Intervention
Intervention · BEHAVIORAL
This arm involves interventions like health coaching, dietary changes, exercise programs, and other lifestyle modifications.
- Standard Health Education
Intervention · OTHER
Participants in the Standard of Care Arm will receive basic educational materials focused on general cognitive and physical health maintenance.
Study details
- Official title
- Intervention Strategies for Preserving Intellectual Resilience and Engagement
- Sponsor
- Healthy Minds Initiative
- Conditions
- Dementia
- Enrolling
- 2,000 people
- Starts
- 2025-06-01
- Est. completion
- 2028-12-01
- Design
- Double-blind, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 55 Years – 85 YearsSex ALLHealthy volunteers AcceptedYou may qualify if
- 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.
You can't join if
- 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openCrenshaw Christian Center
Los Angeles, California, United States
- Brenda Bennett · Contact323-758-3777bbennett@Faithdome.org
- Dean Sherzai, MD, PhD · Principal investigator
- Mohsen Bazargan, PhD · Sub-investigator
Recruiting
Study team
Sponsor
Healthy Minds Initiative
Study ID 20211795
Principal investigator
Dean Sherzai, MD, PhD
Healthy Minds Initiative
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.