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

ConditionDementia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age55-85
SponsorHealthy Minds Initiative

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Lifestyle Intervention

    Behavioral

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

  • Standard Health Education

    Other intervention

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

Treatment groups

2,000 Participants
are divided into 2 treatment groups
Group A: Lifestyle InterventionExperimental treatment 1 intervention
Group B: Standard Health EducationActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in Cognitive Function

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.

Time frame
6 months, 1 year and 3 years

Secondary outcomes

1

Adherence to Lifestyle Interventions

Measure adherence to prescribed diet and exercise changes through self-reported questionnaires and logs maintained by health coaches.

Time frame
Continuous, with key evaluations at 6 months and 12 months.

Other outcomes

1

Change in Blood Pressure

Evaluate changes in blood pressure, as measured by sphygmomanometer at baseline, and then at 6 months, 1 year and 3 years.

Time frame
6 months, 1 year and 3 years
2

Change in Low Density Lipoprotein (LDL) cholesterol levels

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.

Time frame
6 months, 1 year and 3 years
3

Change in Hemoglobin A1c markers

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.

Time frame
6 months, 1 year and 3 years
4

Executive functions composite

Composite score of executive function cognitive test, as measured by TABCAT.

Time frame
6 months, 1 year and 3 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Healthy Minds Initiative

Lead sponsor

American College of Lifestyle Medicine

Collaborator

Charles Drew University of Medicine and Science

Collaborator

University of California, Los Angeles

Collaborator

Stanford University

Collaborator