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| Name | Class |
|---|---|
| American College of Lifestyle Medicine | OTHER |
| Charles Drew University of Medicine and Science | OTHER |
| University of California, Los Angeles | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lifestyle Intervention | Experimental | This arm involves an active intervention with health coaching and lifestyle changes. |
|
| Standard Health Education | Active Comparator | This arm receives a standard educational approach without the intensive intervention. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lifestyle Intervention | Behavioral | This arm involves interventions like health coaching, dietary changes, exercise programs, and other lifestyle modifications. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months, 1 year and 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Adherence to Lifestyle Interventions | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months, 1 year and 3 years |
| Change in Low Density Lipoprotein (LDL) cholesterol levels |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dean Sherzai, MD, PhD | Contact | 949-383-6729 | dean@healthymindsinitiative.org | |
| Caroline Segalla, BA | Contact | 808-333-2883 | caroline@healthymindsinitiative.org |
| Name | Affiliation | Role |
|---|---|---|
| Dean Sherzai, MD, PhD | Healthy Minds Initiative | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Crenshaw Christian Center | Recruiting | Los Angeles | California | 90044 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39096926 | Background | Livingston G, Huntley J, Liu KY, Costafreda SG, Selbaek G, Alladi S, Ames D, Banerjee S, Burns A, Brayne C, Fox NC, Ferri CP, Gitlin LN, Howard R, Kales HC, Kivimaki M, Larson EB, Nakasujja N, Rockwood K, Samus Q, Shirai K, Singh-Manoux A, Schneider LS, Walsh S, Yao Y, Sommerlad A, Mukadam N. Dementia prevention, intervention, and care: 2024 report of the Lancet standing Commission. Lancet. 2024 Aug 10;404(10452):572-628. doi: 10.1016/S0140-6736(24)01296-0. Epub 2024 Jul 31. No abstract available. | |
| 37097299 |
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| ID | Term |
|---|---|
| D003704 | Dementia |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D019965 | Neurocognitive Disorders |
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| Stanford University |
| OTHER |
The INSPIRE Study is a randomized controlled trial (RCT) with 2,000 participants aged 55 and older. Participants will be randomly assigned to either an intervention group, receiving a personalized, lifestyle-based program with health coaching, or a control group, receiving standard health education materials. Both groups will undergo baseline and follow-up assessments, including cognitive tests and lifestyle evaluations. The study emphasizes community engagement and lifestyle interventions, aiming to provide insights into the impact of lifestyle changes on cognitive health and to inform public health strategies for dementia prevention in all populations.
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The INSPIRE Study employs a single-blind design, where participants are unaware of their group assignment (intervention or control) to minimize bias in reporting and behavior. However, the investigators and study staff administering the interventions and conducting assessments are not blinded due to the nature of the intervention, which requires direct interaction and coaching. To further reduce potential bias, outcome assessors involved in data analysis will remain blinded to the group assignments until after the primary data analysis is completed.
| Standard Health Education | Other | Participants in the Standard of Care Arm will receive basic educational materials focused on general cognitive and physical health maintenance. |
|
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 | 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 | Composite score of executive function cognitive test, as measured by TABCAT. | 6 months, 1 year and 3 years |
| Episodic Memory Composite | Composite score of episodic memory cognitive test, as measured by TABCAT. | 6 months, 1 year and 3 years |
| Background |
| Schippinger WM, Pichler G. [Prevention of dementia]. Z Gerontol Geriatr. 2023 May;56(3):227-234. doi: 10.1007/s00391-023-02175-2. Epub 2023 Apr 25. German. |
| 38880341 | Background | Willroth EC, Pfund GN, Rule PD, Hill PL, John A, Kyle K, Hassenstab J, James BD. A review of the literature on wellbeing and modifiable dementia risk factors. Ageing Res Rev. 2024 Aug;99:102380. doi: 10.1016/j.arr.2024.102380. Epub 2024 Jun 14. |
| 34836334 | Background | Dominguez LJ, Veronese N, Vernuccio L, Catanese G, Inzerillo F, Salemi G, Barbagallo M. Nutrition, Physical Activity, and Other Lifestyle Factors in the Prevention of Cognitive Decline and Dementia. Nutrients. 2021 Nov 15;13(11):4080. doi: 10.3390/nu13114080. |
| 34933996 | Background | Ward DD, Ranson JM, Wallace LMK, Llewellyn DJ, Rockwood K. Frailty, lifestyle, genetics and dementia risk. J Neurol Neurosurg Psychiatry. 2022 Apr;93(4):343-350. doi: 10.1136/jnnp-2021-327396. Epub 2021 Dec 21. |
| 32554763 | Background | Dhana K, Evans DA, Rajan KB, Bennett DA, Morris MC. Healthy lifestyle and the risk of Alzheimer dementia: Findings from 2 longitudinal studies. Neurology. 2020 Jul 28;95(4):e374-e383. doi: 10.1212/WNL.0000000000009816. Epub 2020 Jun 17. |
| 36546406 | Background | Low LF, Barcenilla-Wong A, Fitzpatrick M, Swaffer K, Brodaty H, Hancock N, McLoughlin J, Naismith S. Dementia lifestyle coach pilot program. Australas J Ageing. 2023 Sep;42(3):508-516. doi: 10.1111/ajag.13169. Epub 2022 Dec 22. |
| 34245588 | Background | Aranda MP, Kremer IN, Hinton L, Zissimopoulos J, Whitmer RA, Hummel CH, Trejo L, Fabius C. Impact of dementia: Health disparities, population trends, care interventions, and economic costs. J Am Geriatr Soc. 2021 Jul;69(7):1774-1783. doi: 10.1111/jgs.17345. |
| 36162365 | Background | Liu C, Murchland AR, VanderWeele TJ, Blacker D. Eliminating racial disparities in dementia risk by equalizing education quality: A sensitivity analysis. Soc Sci Med. 2022 Nov;312:115347. doi: 10.1016/j.socscimed.2022.115347. Epub 2022 Sep 12. |
| 34854531 | Background | Lennon JC, Aita SL, Bene VAD, Rhoads T, Resch ZJ, Eloi JM, Walker KA. Black and White individuals differ in dementia prevalence, risk factors, and symptomatic presentation. Alzheimers Dement. 2022 Aug;18(8):1461-1471. doi: 10.1002/alz.12509. Epub 2021 Dec 2. |
| 26862150 | Background | Sherzai D, Sherzai A, Lui K, Pan D, Chiou D, Bazargan M, Shaheen M. The Association Between Diabetes and Dementia Among Elderly Individuals: A Nationwide Inpatient Sample Analysis. J Geriatr Psychiatry Neurol. 2016 May;29(3):120-5. doi: 10.1177/0891988715627016. Epub 2016 Feb 9. |
| 31523210 | Background | Sherzai D, Sherzai A. Preventing Alzheimer's: Our Most Urgent Health Care Priority. Am J Lifestyle Med. 2019 May 9;13(5):451-461. doi: 10.1177/1559827619843465. eCollection 2019 Sep-Oct. |
| 26086182 | Background | Morris MC, Tangney CC, Wang Y, Sacks FM, Barnes LL, Bennett DA, Aggarwal NT. MIND diet slows cognitive decline with aging. Alzheimers Dement. 2015 Sep;11(9):1015-22. doi: 10.1016/j.jalz.2015.04.011. Epub 2015 Jun 15. |
| 37466280 | Background | Barnes LL, Dhana K, Liu X, Carey VJ, Ventrelle J, Johnson K, Hollings CS, Bishop L, Laranjo N, Stubbs BJ, Reilly X, Agarwal P, Zhang S, Grodstein F, Tangney CC, Holland TM, Aggarwal NT, Arfanakis K, Morris MC, Sacks FM. Trial of the MIND Diet for Prevention of Cognitive Decline in Older Persons. N Engl J Med. 2023 Aug 17;389(7):602-611. doi: 10.1056/NEJMoa2302368. Epub 2023 Jul 18. |
| 25681666 | Background | Morris MC, Tangney CC, Wang Y, Sacks FM, Bennett DA, Aggarwal NT. MIND diet associated with reduced incidence of Alzheimer's disease. Alzheimers Dement. 2015 Sep;11(9):1007-14. doi: 10.1016/j.jalz.2014.11.009. Epub 2015 Feb 11. |
| 37571270 | Background | McLeod A, Bernabe BP, Xia Y, Sanchez-Flack J, Lamar M, Schiffer L, Hemphill NO, Fantuzzi G, Maki P, Fitzgibbon M, Tussing-Humphreys L. Exploring the Effects of a Mediterranean Diet and Weight Loss on the Gut Microbiome and Cognitive Performance in Older, African American Obese Adults: A Post Hoc Analysis. Nutrients. 2023 Jul 27;15(15):3332. doi: 10.3390/nu15153332. |
| D001523 | Mental Disorders |