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Purpose

The goal of this study is to determine if weight loss or changes 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

Eligibility

Eligible Ages
Between 18 Years and 64 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion 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.

Exclusion Criteria

  • 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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Prevention
Masking
Double (Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Weight Loss 		- Follow a reduced calorie diet daily for 12 months. - Attend monthly behavioral counseling/education
  • Behavioral: Diet
    A reduced calorie diet which uses frozen meals purchased at the store and focuses on increasing fruits and vegetables associated with brain health.
  • Behavioral: Health Education
    Monthly health education sessions delivered remotely.
Active Comparator
General Health Education Control 		- Attend monthly health education sessions about general health.
  • Behavioral: Health Education
    Monthly health education sessions delivered remotely.

Recruiting Locations

University of Kansas Medical Center
Kansas City, Kansas 66160
Contact:
Lauren Ptomey, PhD

More Details

Status
Recruiting
Sponsor
University of Kansas Medical Center

Study Contact

Lauren Ptomey, PhD
913-588-7982
lptomey@kumc.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.