The INSPIRE -Faith Study: Intervention Strategies for Preserving Intellectual Resilience and Engagement (INSPIRE -Faith)

May 26, 2026 updated by: Healthy Minds Initiative

Intervention Strategies for Preserving Intellectual Resilience and Engagement

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

2000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90044
        • Recruiting
        • Crenshaw Christian Center
        • Contact:
        • Principal Investigator:
          • Dean Sherzai, MD, PhD
        • Sub-Investigator:
          • Mohsen Bazargan, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lifestyle Intervention
This arm involves an active intervention with health coaching and lifestyle changes.
Behavioral: Lifestyle Intervention
This arm involves interventions like health coaching, dietary changes, exercise programs, and other lifestyle modifications.
Active Comparator: Standard Health Education
This arm receives a standard educational approach without the intensive intervention.
Other: Standard Health Education
Participants in the Standard of Care Arm will receive basic educational materials focused on general cognitive and physical health maintenance.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Cognitive Function
Time Frame: 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.
6 months, 1 year and 3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adherence to Lifestyle Interventions
Time Frame: 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.
Continuous, with key evaluations at 6 months and 12 months.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Blood Pressure
Time Frame: 6 months, 1 year and 3 years
Evaluate changes in blood pressure, as measured by sphygmomanometer at baseline, and then at 6 months, 1 year and 3 years.
6 months, 1 year and 3 years
Change in Low Density Lipoprotein (LDL) cholesterol levels
Time Frame: 6 months, 1 year and 3 years
Evaluate changes in Low Density Lipoprotein, as measured by a lipid panel serum test at baseline, and then at 6 months, 1 year and 3 years.
6 months, 1 year and 3 years
Change in Hemoglobin A1c markers
Time Frame: 6 months, 1 year and 3 years
Evaluate changes in serum Hemoglobin A1c, a marker of glucose metabolism dysfunction, as measured in the serum, at baseline and then at 6 months, 1 year and 3 years.
6 months, 1 year and 3 years
Executive functions composite
Time Frame: 6 months, 1 year and 3 years
Composite score of executive function cognitive test, as measured by TABCAT.
6 months, 1 year and 3 years
Episodic Memory Composite
Time Frame: 6 months, 1 year and 3 years
Composite score of episodic memory cognitive test, as measured by TABCAT.
6 months, 1 year and 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Healthy Minds Initiative

Collaborators

University of California, Los Angeles
Stanford University
Charles Drew University of Medicine and Science
American College of Lifestyle Medicine

Investigators

  • Principal Investigator: Dean Sherzai, MD, PhD, Healthy Minds Initiative

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2025

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

August 12, 2024

First Submitted That Met QC Criteria

December 15, 2024

First Posted (Actual)

December 19, 2024

Study Record Updates

Last Update Posted (Actual)

May 28, 2026

Last Update Submitted That Met QC Criteria

May 26, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20211795

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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