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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)

Must not have

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

History of major depression within the last 12 months

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from baseline to month 4

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I will not travel outside my local area for more than 3 months during the study.

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I lead a mostly inactive lifestyle.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not been diagnosed with major depression in the past year.

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I have not had a serious diabetic event in the last 6 months.

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I am currently receiving hospice care.

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I need steroids or extra oxygen for my lung condition, but asthma treatments are okay.

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I am currently in physical therapy or cardiopulmonary rehab.

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I have kidney disease.

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I am unable to give consent for myself.

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I am younger than 60 years old.

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I have not had hip, joint, or spinal surgery in the last 6 months.

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I do not have any major brain or nerve conditions like dementia, Parkinson's, or MS.

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I use or have used insulin for type 2 diabetes.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline to month 4 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in DDPP Neuropsychological Test Battery

Secondary study objectives

Change in 6-Minute Walk Test

Change in Body Mass Index (BMI)

Change in Chair Rise

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 14Eligibility criteria met