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 volunteersQualifiers
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
Parallel
Treatments tested in this trial
Lifestyle Intervention
BehavioralThis arm involves interventions like health coaching, dietary changes, exercise programs, and other lifestyle modifications.
Standard Health Education
Other interventionParticipants in the Standard of Care Arm will receive basic educational materials focused on general cognitive and physical health maintenance.
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
Adherence to Lifestyle Interventions
Measure adherence to prescribed diet and exercise changes through self-reported questionnaires and logs maintained by health coaches.
Other outcomes
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.
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.
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.
Executive functions composite
Composite score of executive function cognitive test, as measured by TABCAT.
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