Walk and eat smart: new study aims to ward off dementia and diabetes
NCT ID NCT04141878
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests two lifestyle programs in 400 older African American and non-Hispanic white adults at risk for dementia and diabetes. One group does aerobic exercise three times a week; the other learns to follow the MIND diet, which emphasizes berries, greens, and whole grains. Researchers will measure changes in thinking skills and fitness over time to see if these habits can prevent disease.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Aerobic exercise and dietary counseling (MIND diet)
- What this could lead to
- If successful, this program could show that combining exercise and a healthy diet helps prevent dementia and diabetes in older adults.
- What could go wrong
- This is a behavioral study, not a drug trial, so results may be modest. Participants must stick to the program for benefits, and outcomes depend on self-report and adherence.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 400 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2021
- Expected to finish
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Jun 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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60 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 Criteria: * 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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University of California, Davis Alzheimer's Disease Center
RECRUITINGWalnut Creek, California, 94598, United States
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