Recruiting

Lifestyle Factors

Sponsor:

Healthy Minds Initiative

Code:

NCT06741865

Conditions

Dementia

Eligibility Criteria

Sex: All

Age: 55 - 70+

Healthy Volunteers: Accepted

Interventions

Lifestyle Intervention

Standard Health Education

Study Details

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.

Conditions

Dementia

Study ID

NCT06741865

Start date

Jun 1, 2025

Status verified date

May, 2026

Completion date

Dec 1, 2028

Anticipated

Primary completion date

Jun 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 55 - 70+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

2000 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Lifestyle Intervention

This arm involves an active intervention with health coaching and lifestyle changes.

active comparator: Standard Health Education

This arm receives a standard educational approach without the intensive intervention.

Interventions

Lifestyle Intervention

This arm involves interventions like health coaching, dietary changes, exercise programs, and other lifestyle modifications.

Standard Health Education

Participants in the Standard of Care Arm will receive basic educational materials focused on general cognitive and physical health maintenance.

Primary outcome measure

  • Change in Cognitive Function [ Time Frame: 6 months, 1 year and 3 years ]

Central Contacts and Locations

Central contacts

Dean Sherzai, MD, PhD

949-383-6729dean@healthymindsinitiative.org

Caroline Segalla, BA

808-333-2883caroline@healthymindsinitiative.org

Locations

Crenshaw Christian Center

Recruiting

Los Angeles, California, United States, 90044

Contacts

Brenda Bennett

323-758-3777bbennett@Faithdome.org

Principal Investigator:

Dean Sherzai, MD, PhD

More Information

Sponsor

Healthy Minds Initiative

Last update posted

May 28, 2026

Last verified

May, 2026

Keywords

  • Dementia
  • Alzheimer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Healthy Minds Initiative on 2026-05-28.