Brain Outcomes With Lifestyle Change in Down Syndrome
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
- Down Syndrome
- Alzheimer Disease
- Obesity
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
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Weight Loss |
- Follow a reduced calorie diet daily for 12 months. - Attend monthly behavioral counseling/education |
|
|
Active Comparator General Health Education Control |
- Attend monthly health education sessions about general health. |
|
Recruiting Locations
Kansas City, Kansas 66160
Lauren Ptomey, PhD
More Details
- Status
- Recruiting
- Sponsor
- University of Kansas Medical Center