Lifestyle Interventions for Dementia Prevention
(DDPP Trial)
Recruiting in Palo Alto (17 mi)
Overseen byDavid K Johnson, PhD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of California, Davis
Must not be taking: Psychoactive medications, Opiate analgesics
Disqualifiers: Neurologic disease, Major depression, Bipolar, Schizophrenia, others
No Placebo Group
Trial Summary
What is the purpose of this trial?This is a multicenter, randomized 2-arm clinical trial of two lifestyle interventions varying in intensity and format, in 400 older African American and non-Hispanic whites at increased risk of cognitive decline and dementia in the East San Francisco Bay Area. The trial will include two lifestyle interventions that differ in intensity and format:
1. Aerobic Exercise (AEx) Intervention that involves aerobic activities with in-class walking workouts and tutorials and carried out at the East Oakland Sports Center (EOSC) and Tice Creek Fitness Center (TICE).
2. Dietary counseling to support adherence to the Mediterranean-Diet Approaches to Stop Hypertension (DASH) Intervention for Neurodegenerative Delay (MIND) diet to encourage increased consumption of berries, green leafy and other vegetables, whole grains, nuts, fish, poultry, beans and olive oil, and to reduce consumption of fried/fast foods, red meat, whole fat cheese, sweets, butter and trans-fat margarines.
Will I have to stop taking my current medications?
The trial requires that you stop using certain psychoactive medications, like tricyclic antidepressants and antipsychotics, within the last 3 months. However, stable doses of some antidepressants like SSRIs and SNRIs are allowed.
What data supports the effectiveness of the treatment involving lifestyle interventions for dementia prevention?
Research suggests that the MIND diet, which combines elements of the Mediterranean and DASH diets, is linked to better cognitive function and a lower risk of Alzheimer's disease. Additionally, combining physical activity with the MIND diet may help slow the onset of dementia.
12345Is the MIND diet safe for humans?
The MIND diet, which combines elements of the Mediterranean and DASH diets, has been associated with various health benefits, including better cognitive performance and reduced risk of cardiovascular diseases, without any reported safety concerns in humans.
46789How is the Lifestyle Interventions for Dementia Prevention treatment different from other treatments for dementia?
This treatment is unique because it combines aerobic exercise and the MIND diet, which focuses on eating more vegetables, berries, nuts, and fish while reducing meat and sugar intake, to potentially slow the onset of dementia. Unlike drug treatments, this approach targets lifestyle changes, which are modifiable risk factors for dementia.
210111213Eligibility Criteria
This trial is for older African Americans and non-Hispanic whites at risk of cognitive decline, who are sedentary with a poor diet but without significant cognitive impairment or physical disabilities. Participants must not plan extensive travel during the study and be willing to join either lifestyle intervention group.Inclusion Criteria
I am willing to follow a new lifestyle plan as part of the study.
Lives in a region where the DDPP interventions will be delivered
I will not travel outside my local area for more than 3 months during the study.
+5 more
Exclusion Criteria
I haven't had treatment for cancer, except for certain skin or early stage cancers, in the last 2 years.
I have had weight loss surgery that affects how my body absorbs food.
I have not been diagnosed with major depression in the past year.
+19 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants undergo an 8-month lifestyle intervention program including aerobic exercise and dietary counseling
32 weeks
Weekly visits for 20 weeks, then flexible scheduling
Follow-up
Participants are monitored for changes in fitness and cognitive performance
4 months
Follow-up visits at Month 4
Participant Groups
The trial tests two interventions: an Aerobic Exercise program with in-class walking workouts, and dietary counseling based on the MIND diet aimed at improving brain health by eating more berries, vegetables, grains, nuts, fish, poultry, beans and olive oil while reducing unhealthy fats and red meat.
2Treatment groups
Active Control
Group I: Aerobic Exercise GroupActive Control1 Intervention
Participants will follow a structured program that includes exercise 3 times per week for about 30 minutes each time. The type of aerobic exercise will vary, but will primarily focus on in-class walking tutorials. Participants will work with a Personal Trainer to create their own physical activity program that will fit their needs and schedule. The Personal Trainer will supervise the participants directly for the first 6 weeks. Once participants are consistently and safely meeting their goals, their Personal Trainer will allow unsupervised exercise sessions.
Group II: Diet Skills GroupActive Control1 Intervention
Participants will attend weekly classes focused on incorporating heart healthy foods (e.g., fruits and vegetables) into their existing dietary plan. We will ask them to limit the number of calories they take in and will show them how to use portion control with the goal of losing body weight. Participants will also learn hands-on skills for preparing healthy meals at home in cooking classes led by professional chefs.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of California, Davis Alzheimer's Disease CenterWalnut Creek, CA
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Who Is Running the Clinical Trial?
University of California, DavisLead Sponsor
Tice Creek Fitness CenterCollaborator
East Oakland Sports CenterCollaborator
References
Impact of the MIND Diet on Cognition in Individuals with Dementia. [2023]Alzheimer's disease (AD) plagues 6.5 million Americans 65+, yet treatments are lacking. The Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) diet has been developed to address the expansive impact of dementias on the general public. This systematic review evaluated the impact of the MIND diet on cognition in those with pathologies across the dementia spectrum.
Association of adherence to high-intensity physical activity and the Mediterranean-dietary approaches to stop hypertension intervention for neurodegenerative delay diet with cognition: A cross-sectional study. [2022]Prevention is a priority in the absence of a cure for dementia. Physical activity and a neuroprotective diet such as the Mediterranean-Dietary Approaches to Stop Hypertension Intervention for Neurodegenerative Delay (MIND) diet are healthy lifestyle behaviors that may slow the onset of dementia. However, research on the relationship between the combination of physical activity and the MIND diet and cognition is rare.
Trial of the MIND Diet for Prevention of Cognitive Decline in Older Persons. [2023]Findings from observational studies suggest that dietary patterns may offer protective benefits against cognitive decline, but data from clinical trials are limited. The Mediterranean-DASH Intervention for Neurodegenerative Delay, known as the MIND diet, is a hybrid of the Mediterranean diet and the DASH (Dietary Approaches to Stop Hypertension) diet, with modifications to include foods that have been putatively associated with a decreased risk of dementia.
The Mediterranean, Dietary Approaches to Stop Hypertension (DASH), and Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) Diets Are Associated with Less Cognitive Decline and a Lower Risk of Alzheimer's Disease-A Review. [2023]As there is currently no cure for dementia, there is an urgent need for preventive strategies. The current review provides an overview of the existing evidence examining the associations of the Mediterranean, Dietary Approaches to Stop Hypertension (DASH), and Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) diets and their dietary components with cognitive decline, dementia, and Alzheimer's disease (AD). A systematic search was conducted within Ovid Medline for studies published up to 27 March 2019 and reference lists from existing reviews and select articles were examined to supplement the electronic search results. In total, 56 articles were included. Higher adherence to the Mediterranean diet was associated with better cognitive scores in 9 of 12 cross-sectional studies, 17 of 25 longitudinal studies, and 1 of 3 trials. Higher adherence to the DASH diet was associated with better cognitive function in 1 cross-sectional study, 2 of 5 longitudinal studies, and 1 trial. Higher adherence to the MIND diet was associated with better cognitive scores in 1 cross-sectional study and 2 of 3 longitudinal studies. Evidence on the association of these dietary patterns with dementia in general was limited. However, higher adherence to the Mediterranean diet was associated with a lower risk of AD in 1 case-control study and 6 of 8 longitudinal studies. Moreover, higher adherence to the DASH or MIND diets was associated with a lower AD risk in 1 longitudinal study. With respect to the components of these dietary patterns, olive oil may be associated with less cognitive decline. In conclusion, current scientific evidence suggests that higher adherence to the Mediterranean, DASH, or MIND diets is associated with less cognitive decline and a lower risk of AD, where the strongest associations are observed for the MIND diet.
My Healthy Brain: Rationale and Case Report of a Virtual Group Lifestyle Program Targeting Modifiable Risk Factors for Dementia. [2023]Nearly half of dementia cases may be explained by modifiable lifestyle risk factors. Multidomain interventions are needed to bypass cognitive decline (CD) and aging-related barriers to sustained healthy lifestyles in at-risk older adults. We iteratively developed My Healthy Brain, a group-based lifestyle program (8 weeks, 90 min sessions) delivered via live video that applies behavioral principles to target multiple risk factors for dementia. We describe the program structure, virtual delivery, and outcomes for a group of older adults with subjective CD or mild cognitive impairment and lifestyle risk factors (e.g., sedentary, poor sleep or diet). We also conducted a group exit interview to qualitatively assess participant experiences and elicit feedback to improve My Healthy Brain. This case report demonstrates that delivering evidence-based brain health education and behavior change skills in a group setting via live video is feasible, acceptable, and has the potential to improve lifestyle, cognitive, and psychosocial outcomes in older adults with CD.
Better adherence to the MIND diet is associated with lower risk of all-cause death and cardiovascular death in patients with atherosclerotic cardiovascular disease or stroke: a cohort study from NHANES analysis. [2023]The Mediterranean-DASH intervention for neurodegenerative delay (MIND) diet has been evaluated as a brain-protective diet pattern that contributes to better cognitive performance and attenuates dementia. Cardioprotective effects of the MIND diet have been demonstrated in the primary prevention of atherosclerotic cardiovascular disease (ASCVD), however, there is no exploration in patients with ASCVD. In this prospective cohort study, 943 patients with ASCVD or stroke from the National Health and Nutrition Examination Survey (NHANES) from 2003 to 2006 were enrolled and divided into three groups according to the MIND diet scores (≤7.0, 7.5-8.0, and ≥8.5). Compared with patients with low MIND diet scores (≤7.0), patients with better adherence to the MIND diet presented a significantly lower risk of all-cause and CV death, as results showed that the hazard ratio [HR] and 95% confidence interval [CI] were 1.09 (0.78, 1.52) in the group of 7.5-8.0, 0.66 (0.50, 0.87) in the group of ≥8.5 for all-cause mortality (P trend = 0.002); 0.70 (0.42, 1.17) in the group of 7.5-8.0 and 0.52 (0.35, 0.75) in the group of ≥8.5 for CV mortality (P for trend < 0.001). Besides, per one-score increase in the MIND diet score was associated with a 10% (HR = 0.90, 95% CI: 0.82, 0.99) lower risk of all-cause mortality and a 16% (HR = 0.84, 95% CI: 0.73, 0.97) lower risk of CV mortality in these patients. In conclusion, this study, for the first time, revealed that better adherence to the MIND diet was associated with improved outcomes in patients with ASCVD.
MIND Diet Adherence Might be Associated with a Reduced Odds of Multiple Sclerosis: Results from a Case-Control Study. [2022]The Mediterranean Dietary Approaches to the Stop Hypertension (DASH) Intervention for Neurodegenerative Delay (MIND) diet has been shown to have beneficial neuroprotective effects. The purpose of this research was to evaluate the link between the MIND diet adherence and multiple sclerosis (MS), a degenerative neurological illness.
Associations of the MIND Diet with Cardiometabolic Diseases and Their Risk Factors: A Systematic Review. [2023]Recent studies have expanded the scope of research on the Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) diet beyond its impact on cognitive performance. These investigations have specifically explored its potential to provide protection against cardiometabolic diseases and associated risk factors, including obesity and dyslipidemia.
Evaluating the association between the Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) diet, mental health, and cardio-metabolic risk factors among individuals with obesity. [2023]Several previous investigations have examined the brain-protective role of the Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) diet. However, more knowledge is needed about the MIND diet's other favorable impacts. The purpose of this study was to examine the relationship between the MIND diet, mental health, and metabolic markers in individuals with obesity.
Lifestyle change and the prevention of cognitive decline and dementia: what is the evidence? [2018]Effective pharmaceutical treatment of dementia is currently unavailable. Epidemiological work has, however, identified modifiable lifestyle factors, such as poor diet and physical and cognitive inactivity, that are associated with the risk of dementia. These factors may be useful targets for the prevention of cognitive impairment and dementia. Much recent research has, therefore, adopted an interventional focus. We review this work, highlight some methodological limitations, and provide recommendations for future research.
Association of a MIND Diet with Brain Structure and Dementia in a French Population. [2022]Adherence to the Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) diet, which combines higher consumption of vegetables, berries, nuts, whole grains, olive oil, fish, beans and poultry, with lower consumption of meat, sugars and saturated fats, is a promising strategy to prevent dementia. However, evidence in populations with non-US food culture, especially from Europe, is limited.
A brief update on dementia prevention. [2021]A large number of published overview and original articles provide evidence and declare the need for immediate, appropriate preventive lifestyle measures to prevent the development of dementia and Alzheimer's disease (AD). However, despite this, there are great difficulties in drafting effective guidelines in this field. This is mainly due to a lack of not only (comparable) randomized controlled trials but also a lack of homogeneous measures of type and degree of managed risk. Several risk factors for dementia are non-modifiable, such as genes and age. Factors related to lifestyle habits and vascular risk factors are classified as modifiable risk factors. While waiting for effective drug therapies and first-level evidence data, geriatricians, general practitioners, neurologists, and health professionals should be encouraged to improve early diagnosis of cognitive impairment and activate control strategies against vascular disease and unhealthy lifestyle habits.
A Remote Intervention to Prevent or Delay Cognitive Impairment in Older Adults: Design, Recruitment, and Baseline Characteristics of the Virtual Cognitive Health (VC Health) Study. [2020]A growing body of evidence supports the use of lifestyle interventions for preventing or delaying the onset of Alzheimer disease and other forms of dementia in at-risk individuals. The development of internet-delivered programs would increase the scalability and reach of these interventions, but requires validation to ensure similar effectiveness to brick-and-mortar options.