Dementia and Diabetes Prevention Program

Part of paid clinical trials in Walnut Creek, California.

Sponsor
University of California, Davis
Study ID
NCT04141878
Status
Recruiting
Apply to this trial

Conditions

  • Dementia
  • Diabetes

Eligibility Criteria

Sex
ALL
Age
60 Years - N/A
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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.

Key Dates

Start date
May 26, 2021
Status verified
Dec 2025
Primary completion
Jun 27, 2026
Completion
Jun 27, 2026

Study Design

Enrollment
400 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION

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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California, Davis Alzheimer's Disease CenterWalnut CreekCalifornia94598
Andrea Alioto, PhD
[email protected]
925-357-6515
David K Johnson, PhD
[email protected]
785-342-2778
David K Johnson, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
University of California, Davis Alzheimer's Disease Center· Walnut Creek, CA

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