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Dementia and Diabetes Prevention Program

NCT04141878 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2025-12-05

No results posted yet for this study

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

Interventions

BEHAVIORAL

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.

BEHAVIORAL

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.

Sponsors & Collaborators

  • East Oakland Sports Center

    collaborator UNKNOWN

  • Tice Creek Fitness Center

    collaborator UNKNOWN

  • University of California, Davis

    lead OTHER

Principal Investigators

  • David K Johnson, PhD · University of California, Davis

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-26
Primary Completion
2026-06-27
Completion
2026-06-27

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04141878 on ClinicalTrials.gov