Recruiting

Dementia & DiabetesDementia and Diabetes Prevention Program

Sponsor:

UCLA

Code:

NCT04141878

Conditions

Diabetes

Dementia

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

Interventions

Aerobic Exercise

Diet Skills

Study Details

Brief summary:

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

Diabetes

Dementia

Study ID

NCT04141878

Start date

May 26, 2021

Status verified date

Dec, 2025

Completion date

Jun 27, 2026

Anticipated

Primary completion date

Jun 27, 2026

Anticipated

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

400 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: Aerobic Exercise Group

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.

active comparator: Diet Skills Group

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.

Interventions

Aerobic Exercise

Participants will follow a structured program that includes exercise 3 times per week for about 30 minutes each time. The type of aerobic exercise may vary, but will primarily focus on walking tutorials.

Diet Skills

Participants will attend weekly classes focused on incorporating heart healthy foods into their existing diets. Calories will be restricted, and portion control will be taught with the goal of losing body weight. Hands-on skills will be taught for preparing healthy home-cooked meals by professional chefs.

Primary outcome measure

Change in DDPP Neuropsychological Test Battery [ Time Frame: Change from Baseline to Month 4 ]

Central Contacts and Locations

Central contacts

Andrea Alioto, PhD

925-357-6515 agalioto@ucdavis.edu

David K Johnson, PhD

785-342-2778 dkj@ucdavis.edu

Locations

University of California, Davis Alzheimer's Disease Center

Recruiting

Walnut Creek, California, United States, 94598

Contacts

Andrea Alioto, PhD

925-357-6515 agalioto@ucdavis.edu

David K Johnson, PhD

785-342-2778 dkj@ucdavis.edu

Principal Investigator:

David K Johnson, PhD

More Information

Sponsor

University of California, Davis

Last update posted

Dec 5, 2025

Last verified

Dec, 2025

Keywords

Diabetes
Dementia
Prevention

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, Davis on 2025-12-05.