Dementia and Diabetes Prevention Program

NCT04141878 | Recruiting

• 1 other identifier: 1464339
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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. 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. 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

Keywords

Diabetes; Dementia; Prevention

Outcome Measures

Primary Outcomes (1)

• Change in DDPP Neuropsychological Test Battery

  Cognitive Performance

  Change from Baseline to Month 4

Secondary Outcomes (5)

• Change in 6-Minute Walk Test

  Change from Baseline to Month 4

• Change in Hand-Grip Strength

  Change from Baseline to Month 4

• Change in Chair Rise

  Change from Baseline to Month 4

• Change in Body Mass Index (BMI)

  Change from Baseline to Month 4

• Change in Glycated Hemoglobin (Hemoglobin A1C)

  Change from Baseline to Month 4

Study Arms (2)

Aerobic Exercise Group

ACTIVE COMPARATOR

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.

Behavioral: Aerobic Exercise

Diet Skills Group

ACTIVE COMPARATOR

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.

Behavioral: Diet Skills

Interventions

Aerobic Exercise BEHAVIORAL

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.

Aerobic Exercise Group

Diet Skills BEHAVIORAL

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.

Diet Skills Group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Davis: lead
• East Oakland Sports Center: collaborator
• Tice Creek Fitness Center: collaborator

Study Sites (1)

University of California, Davis Alzheimer's Disease Center

Walnut Creek, California, 94598, United States

RECRUITING

Related Links

• Learn more or sign up for the study here!

MeSH Terms

Conditions

Diabetes Mellitus; Dementia

Interventions

Exercise

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• David K Johnson, PhD

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrea Alioto, PhD

CONTACT

925-357-6515; agalioto@ucdavis.edu

David K Johnson, PhD

CONTACT

785-342-2778; dkj@ucdavis.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: There is no masking in this study. Everyone will know whether the participant is currently participating in the Aerobic Exercise Group or the Diet Skills Group. All participants will eventually complete both groups.
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Subjects will be randomized to either the Aerobic Exercise Group or the Diet Skills Group. Each participant will eventually complete both groups.

Study Record Dates

• First Submitted: October 15, 2019
• First Posted: October 28, 2019
• Study Start: May 26, 2021
• Primary Completion (Estimated): June 27, 2026
• Study Completion (Estimated): June 27, 2026
• Last Updated: December 5, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)