Brain Outcomes With Lifestyle Change in Down Syndrome

Description

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.

Conditions

Down Syndrome, Alzheimer Disease, Obesity

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Study Overview

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Study Details

Study overview

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.

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

Brain Outcomes With Lifestyle Change in Down Syndrome

Condition
Down Syndrome
Intervention / Treatment

-

Contacts and Locations

Kansas City

University of Kansas Medical Center, Kansas City, Kansas, United States, 66160

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Diagnosis of Down syndrome
  • * BMI of 25 to 45 kg/m2
  • * Ability to communicate through spoken language.
  • * Ability to come to the University of Kansas Medical Center 3 times across 1 year for outcomes testing
  • * Living at home with a parent/guardian, or in a supported living environment with a caregiver who assists with food shopping, meal planning, and meal preparation and agrees to serve as a study partner including providing transportation to our facilities for study assessments.
  • * Diagnosis of dementia
  • * Insulin dependent diabetes
  • * Participation in a weight management program involving diet or physical activity in the past 6 mos.
  • * Dairy allergy
  • * Serious medical risk (e.g., cancer, recent heart attack, stroke, pregnancy, angioplasty)
  • * Unwilling to be randomized
  • * Contraindications for MRI, including metal implants or devices incompatible with MRI such as pacemakers, claustrophobia, and inability to lay in a supine position
  • * Use of GLP-1 medications
  • * Use of anti-amyloid medications

Ages Eligible for Study

18 Years to 64 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Kansas Medical Center,

Study Record Dates

2027-09-30