Dementia and Diabetes Prevention Program
This study is looking at two lifestyle programs, Aerobic Exercise and Diet Skills, to see if they can help prevent cognitive decline and dementia in older adults who are at higher risk. The study will involve 400 African American and non-Hispanic white participants in the East San Francisco Bay Area. You would participate in either a structured exercise program focusing on walking three times a week, or weekly classes on healthy eating, portion control, and calorie restriction to help with weight loss. Researchers will measure changes in your cognitive function using a special test battery to see if these programs are successful.
- Study design
- This is a randomized study comparing two different lifestyle programs. It plans to enroll 400 participants.
- What's involved
- You would participate in either aerobic exercise three times a week for about 30 minutes, or attend weekly diet classes. The primary endpoint is measured at Month 4.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your cognitive function will be assessed at Month 4 after the start of the study.
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NCT04141878
Dementia and Diabetes Prevention Program
Recruiting
NAAges 60+InterventionalPreventionUniversity of California, DavisInvestigator-initiated
~400 participants
Updated 2025-12-05 on ClinicalTrials.gov
What's tested:Aerobic ExerciseDiet Skills
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in DDPP Neuropsychological Test Battery
Measured over Change from Baseline to Month 4
Conditions
Where it's being run
1 sites across 1 statesCalifornia1
Study leadership
- David K Johnson, PhD · PRINCIPAL_INVESTIGATOR · University of California, Davis
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Sedentary (as per the Telephone Assessment of Physical Activity)
Poor diet (as per the MIND Diet Screener)
Cognitive function: absence of significant cognitive impairment as per the modified Telephone Interview for Cognitive Status (TICSm; age-, education-, and race-adjusted TICSm \>32)
Lives in a region where the DDPP interventions will be delivered
Does not plan to travel outside of the home geographic area for more than 3 months over the course of the study
Free of physical disabilities that preclude participation in the study
Willing to complete all study-related activities for 32 weeks
Willing to be randomized to either lifestyle intervention group
Exclusion
Age \<60
Body Mass Index (BMI) \>40
Any significant neurologic disease, including any form of dementia, Parkinson's disease, Huntington's disease, normal pressure hydrocephalus, brain tumor, progressive supranuclear palsy, seizure disorder, subdural hematoma, multiple sclerosis, or history of significant head trauma with persistent neurologic sequelae or known structural brain abnormalities
History of major depression within the last 12 months
History of bipolar disorder or schizophrenia as per Diagnostic and Statistical Manual of Mental Disorders (DSM) V criteria
History of alcohol or substance abuse or dependence within the past 2 years, as per DSM V criteria
Use of psychoactive medications within the last 3 months including tricyclic antidepressants, antipsychotics, mood-stabilizing psychotropic agents (e.g., lithium salts), psychostimulants, opiate analgesics, antiparkinsonian medications, anticonvulsant medications (except gabapentin and pregabalin for non-seizure indications), systemic corticosteroids, or medications with significant central anticholinergic activity; in the absence of major depression, stable dose use of selective serotonin reuptake inhibitors or serotonin and norepinephrine reuptake inhibitors are allowed
Health profiles that would jeopardize their safety to participate: (Screen failures will be referred immediately to a physician for medical examination): (1) Myocardial infarction or symptoms of unstable coronary artery disease (e.g., angina) in the last six months, (2) Uncontrolled hypertension within the past 6 months, (3) Morbid obesity (BMI\<40), (4) History of clinically-evident stroke, (5) Clinically-significant infection within the past 30 days, (6) Significant pain or musculoskeletal disorder limiting the ability to participate safely, or (7) Clinically significant
Past or current use of insulin to treat type 2 diabetes
Serious diabetic event within 6 months of enrollment
Lung disease requiring either regular use of corticosteroids or the use of supplemental oxygen (inhaled steroids for asthma is permissible)
Renal disease
Clinically significant abnormalities in laboratory blood tests as per judgment of the Study Physician
History within the last 2 years of treatment for primary or recurrent malignant disease, excluding non-melanoma skin cancers, resected cutaneous squamous cell carcinoma in situ, basal cell carcinoma, cervical carcinoma in situ, or in situ prostate cancer with normal prostate-specific antigen post-treatment
History of hip fracture, joint replacement, or spinal surgery in the last 6 months
Currently receiving physical therapy or cardiopulmonary rehabilitation
History of a malabsorptive bariatric procedure (gastric bypass, biliopancreatic diversion); other bariatric procedures involving restriction (i.e., sleeve, band) are not exclusionary
For women: currently pregnant, pregnant within the past 6 months, or planning to become pregnant within the next 6 months
Currently incarcerated
Receiving hospice care
Adults unable to provide consent for participation
PI/Study Physician discretion regarding appropriateness of participation or concern about intervention adherence
What this trial measures
- Change in DDPP Neuropsychological Test BatteryChange from Baseline to Month 4
Cognitive Performance