Actively Recruiting
Dementia and Diabetes Prevention Program
Led by University of California, Davis · Updated on 2025-12-05
400
Participants Needed
1
Research Sites
265 weeks
Total Duration
On this page
Sponsors
U
University of California, Davis
Lead Sponsor
E
East Oakland Sports Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Dementia and Diabetes Prevention Program
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Sedentary as measured by the Telephone Assessment of Physical Activity
- Poor diet as measured by the MIND Diet Screener
- No significant cognitive impairment with score >32 on modified Telephone Interview for Cognitive Status adjusted for age, education, and race
- Lives in the geographic area where the DDPP interventions are delivered
- Does not plan to travel outside the study area for more than 3 months during the study
- No physical disabilities that prevent participation
- Willing to complete all study activities for 32 weeks
- Willing to be randomized to either lifestyle intervention group
You will not qualify if you...
- Age under 60 years
- Body Mass Index (BMI) over 40
- Significant neurological diseases including dementia, Parkinson's, Huntington's, normal pressure hydrocephalus, brain tumor, progressive supranuclear palsy, seizure disorder, subdural hematoma, multiple sclerosis, or history of significant head trauma with lasting neurological effects
- Major depression within the last 12 months
- Bipolar disorder or schizophrenia as defined by DSM V
- Alcohol or substance abuse or dependence within past 2 years per DSM V
- Use of psychoactive medications within last 3 months except stable selective serotonin reuptake inhibitors or serotonin-norepinephrine reuptake inhibitors without major depression
- Health conditions that risk safety including recent myocardial infarction or unstable coronary artery disease, uncontrolled hypertension, morbid obesity, stroke, recent significant infection, pain or musculoskeletal disorders limiting safe participation
- Past or current insulin use for type 2 diabetes
- Serious diabetic event within 6 months
- Lung disease requiring regular corticosteroids or supplemental oxygen
- Renal disease
- Significant laboratory blood test abnormalities as judged by study physician
- Cancer treatment within last 2 years except certain skin and in situ cancers
- Hip fracture, joint replacement, or spinal surgery in last 6 months
- Currently receiving physical therapy or cardiopulmonary rehabilitation
- History of malabsorptive bariatric surgery
- For women: pregnant, recently pregnant within 6 months, or planning pregnancy within 6 months
- Currently incarcerated
- Receiving hospice care
- Unable to provide consent
- PI or study physician discretion regarding participation or adherence concerns
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of California, Davis Alzheimer's Disease Center
Walnut Creek, California, United States, 94598
Actively Recruiting
Research Team
A
Andrea Alioto, PhD
CONTACT
D
David K Johnson, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
PREVENTION
Number of Arms
2
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