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Behavioral Intervention
Lifestyle Interventions for Dementia Prevention (DDPP Trial)
N/A
Recruiting
Led By David K Johnson, PhD
Research Sponsored by University of California, Davis
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Does not plan to travel outside of the home geographic area for more than 3 months over the course of the study
Sedentary (as per the Telephone Assessment of Physical Activity)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline to month 4
Awards & highlights
DDPP Trial Summary
This trial will compare the two lifestyle interventions to see which is more effective in reducing the risk of cognitive decline and dementia in older adults.
Who is the study for?
This trial is for older African Americans and non-Hispanic whites at risk of cognitive decline, who are sedentary with a poor diet but without significant cognitive impairment or physical disabilities. Participants must not plan extensive travel during the study and be willing to join either lifestyle intervention group.Check my eligibility
What is being tested?
The trial tests two interventions: an Aerobic Exercise program with in-class walking workouts, and dietary counseling based on the MIND diet aimed at improving brain health by eating more berries, vegetables, grains, nuts, fish, poultry, beans and olive oil while reducing unhealthy fats and red meat.See study design
What are the potential side effects?
While this trial focuses on lifestyle changes rather than medication which typically have fewer side effects; potential risks may include muscle soreness from increased activity levels or digestive changes due to diet adjustments.
DDPP Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I will not travel outside my local area for more than 3 months during the study.
Select...
I lead a mostly inactive lifestyle.
DDPP Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change from baseline to month 4
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline to month 4
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in DDPP Neuropsychological Test Battery
Secondary outcome measures
Change in 6-Minute Walk Test
Change in Body Mass Index (BMI)
Change in Chair Rise
+2 moreDDPP Trial Design
2Treatment groups
Active Control
Group I: Aerobic Exercise GroupActive Control1 Intervention
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.
Group II: Diet Skills GroupActive Control1 Intervention
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.
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Who is running the clinical trial?
University of California, DavisLead Sponsor
911 Previous Clinical Trials
4,709,183 Total Patients Enrolled
9 Trials studying Dementia
3,155 Patients Enrolled for Dementia
Tice Creek Fitness CenterUNKNOWN
East Oakland Sports CenterUNKNOWN
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am willing to follow a new lifestyle plan as part of the study.I haven't had treatment for cancer, except for certain skin or early stage cancers, in the last 2 years.I have had weight loss surgery that affects how my body absorbs food.I have not been diagnosed with major depression in the past year.I have not had a serious diabetic event in the last 6 months.I am currently receiving hospice care.I will not travel outside my local area for more than 3 months during the study.I need steroids or extra oxygen for my lung condition, but asthma treatments are okay.I haven't taken any psychoactive drugs, except for SSRIs or SNRIs for depression, in the last 3 months.I am currently in physical therapy or cardiopulmonary rehab.I have kidney disease.I am unable to give consent for myself.I am younger than 60 years old.Your body mass index (BMI) is higher than 40.You have been diagnosed with bipolar disorder or schizophrenia according to specific medical guidelines.I lead a mostly inactive lifestyle.You have a diet that does not meet certain health guidelines according to the MIND Diet Screener.You have had problems with alcohol or drugs in the past 2 years.I am willing to participate in all study activities for 32 weeks.I do not have physical disabilities that prevent me from joining the study.I have not had hip, joint, or spinal surgery in the last 6 months.You don't have significant problems with your memory or thinking skills, as determined by a specific test.I do not have any major brain or nerve conditions like dementia, Parkinson's, or MS.I use or have used insulin for type 2 diabetes.Your blood test results show important health problems, as decided by the doctor running the study.
Research Study Groups:
This trial has the following groups:- Group 1: Aerobic Exercise Group
- Group 2: Diet Skills Group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Dementia Patient Testimony for trial: Trial Name: NCT04141878 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this trial still open for recruitment?
"Per the information displayed on clinicaltrials.gov, this trial is still in search of participants. The study was originally published on May 26th 2021 and has been revised as recently as January 26th 2022."
Answered by AI
How many people have volunteered to participate in the clinical trial?
"Affirmative. Clinicaltrials.gov states that this clinical trial, first listed on the 26th of May 2021, is actively recruiting patients to participate. 400 individuals need to be enrolled from one site in total."
Answered by AI
Who else is applying?
What state do they live in?
California
What site did they apply to?
University of California, Davis Alzheimer's Disease Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
1
What questions have other patients asked about this trial?
If I am unknown about dementia am I still eligible?
PatientReceived 1 prior treatment
Why did patients apply to this trial?
I want to try anything to help improve my lifestyle.
PatientReceived 2+ prior treatments
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