Dementia and Diabetes Prevention Program (DDPP)

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 60
Healthy Volunteers: f
View:

• 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

Locations
United States
California
University of California, Davis Alzheimer's Disease Center
RECRUITING
Walnut Creek
Contact Information
Primary
Andrea Alioto, PhD
agalioto@ucdavis.edu
925-357-6515
Backup
David K Johnson, PhD
dkj@ucdavis.edu
785-342-2778
Time Frame
Start Date: 2021-05-26
Estimated Completion Date: 2025-06-27
Participants
Target number of participants: 400
Treatments
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.
Related Therapeutic Areas
Sponsors
Collaborators: East Oakland Sports Center, Tice Creek Fitness Center
Leads: University of California, Davis

This content was sourced from clinicaltrials.gov