RecruitingNot ApplicableNCT05985486

Brain Outcomes With Lifestyle Change in Down Syndrome

The Impact of Weight Loss on Alzheimer's Disease Risk in Adults With Down Syndrome


Sponsor

University of Kansas Medical Center

Enrollment

81 participants

Start Date

Oct 22, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this study is to determine if weight loss or changes in dietary intake can help prevent of delay adults with Down syndrome from developing Alzheimer's Disease Adults with Down syndrome without dementia will be randomized to either a weight loss group or a general health education control group. The weight loss group will be asked to follow a reduced energy diet, attend monthly education sessions delivered remotely and self-monitor diet and body weight using commercially available web-based applications. The control group will be asked to attend remotely delivered monthly education sessions on general health education topics. All participants will come to the University of Kansas Medical Center, 3 times across 12 months for a blood draw, cognitive testing, a MRI, assessment of height and weight, and assessment of diet intake.


Eligibility

Min Age: 18 YearsMax Age: 64 Years

Plain Language Summary

Simplified for easier understanding

This study examines whether healthy lifestyle changes — like diet and exercise — can improve brain health and thinking abilities in adults with Down syndrome who are overweight or obese. **You may be eligible if...** - You have a diagnosis of Down syndrome - Your body mass index (BMI) is between 25 and 50 - You can communicate through spoken language - You live at home with family/guardian or in a supported living setting - You are able to visit the University of Kansas Medical Center 3 times over one year **You may NOT be eligible if...** - You are not overweight or have a BMI outside the study range - You are unable to communicate verbally - You cannot travel to the study site Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

BEHAVIORALDiet

A reduced calorie diet which uses frozen meals purchased at the store and focuses on increasing fruits and vegetables associated with brain health.

BEHAVIORALHealth Education

Monthly health education sessions delivered remotely.


Locations(1)

University of Kansas Medical Center

Kansas City, Kansas, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05985486


Related Trials