Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
81 participants
INTERVENTIONAL
2024-10-22
2027-09-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Weight Loss
* Follow a reduced calorie diet daily for 12 months.
* Attend monthly behavioral counseling/education
Diet
A reduced calorie diet which uses frozen meals purchased at the store and focuses on increasing fruits and vegetables associated with brain health.
Health Education
Monthly health education sessions delivered remotely.
General Health Education Control
\- Attend monthly health education sessions about general health.
Health Education
Monthly health education sessions delivered remotely.
Interventions
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Diet
A reduced calorie diet which uses frozen meals purchased at the store and focuses on increasing fruits and vegetables associated with brain health.
Health Education
Monthly health education sessions delivered remotely.
Eligibility Criteria
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Inclusion Criteria
* BMI of 25 to 50 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
* 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
18 Years
64 Years
ALL
No
Sponsors
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University of Kansas Medical Center
OTHER
Responsible Party
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Locations
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University of Kansas Medical Center
Kansas City, Kansas, United States
Countries
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Central Contacts
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Facility Contacts
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Lauren Ptomey, PhD
Role: primary
Other Identifiers
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Study 150542
Identifier Type: -
Identifier Source: org_study_id
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