Brain outcomes with lifestyle change in adults with Down syndrome: Rationale and design for a 12-month randomized trial.
Lauren T Ptomey, Joseph E Donnelly, Jeffery Burns...
https://pubmed.ncbi.nlm.nih.gov/40329624/Actively Recruiting
Led by University of Kansas Medical Center · Updated on 2026-03-11
81
Participants Needed
1
Research Sites
N/A
Total Duration
Researchers are investigating whether weight loss or changes in diet can help prevent or delay the development of Alzheimers disease in adults with Down syndrome who do not have dementia. This study compares the effects of a reduced calorie diet and monthly behavioral counseling with general health education sessions delivered remotely. The goal is to better understand how lifestyle changes may influence Alzheimers risk in this specific population. Participants will be randomly assigned to either a weight loss group or a general health education control group. The weight loss group will follow a reduced calorie diet focusing on frozen meals and increased fruits and vegetables linked to brain health, attend monthly remote education sessions, and self-monitor their diet and weight using web-based applications. The control group will participate in monthly remote sessions about general health topics. The study lasts 12 months. All participants will visit the University of Kansas Medical Center three times during the year for blood draws, cognitive tests, MRI brain scans, and assessments of height, weight, and dietary intake. Researchers will measure blood markers related to Alzheimers disease, body weight, diet quality, brain volume, and cognitive function at baseline, 6 months, and 12 months. This allows comprehensive monitoring of health and brain outcomes throughout the study.
CONDITIONS
Brain Outcomes With Lifestyle Change in Down Syndrome
L
Lauren Ptomey, PhD
J
Jessica Danon
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University of Kansas Medical Center
Lead Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Brain-Healthy Reduced Calorie Diet | General Health Education (Control) |
|---|---|---|
| What it is | A behavioral intervention using a reduced calorie diet based on store-bought frozen meals, increased fruits and vegetables for brain health, designed for adults with Down syndrome and obesity. | A program of monthly health education sessions delivered remotely, focusing on general health topics, not weight loss or brain-specific dietary changes. |
| Role in trial | Experimental arm testing if targeted dietary change can influence brain health and metabolic outcomes. | Active comparator arm designed to control for the effects of regular monthly educational contact. |
| Primary use | Aims to prevent cognitive and metabolic decline by combining calorie reduction with brain-healthy foods. | Provides participants with regular general health information but does not target brain health or weight loss. |
| How it is given or performed | Participants follow a structured diet with support from a caregiver, using frozen meals, increased fruit and vegetable intake, and regular study visits with progress tracking. | Participants attend one remote education session each month, focusing on general health topics, with no assigned dietary changes. |
| Evidence status | Currently being evaluated in a randomized trial; outcome data not yet established for this population. | Acts as an informational comparator; not expected to actively alter brain biomarkers or weight. |
| Important limitations | Requires strong caregiver involvement, may be challenging to maintain dietary changes, and trial outcomes may not generalize beyond adults with Down syndrome and obesity. | Does not provide a structured diet or specific brain health intervention, so observed effects may be limited mainly to engagement and education. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 12 months
Participants follow a reduced calorie diet daily for 12 months with monthly behavioral counseling and education sessions, or attend monthly health education sessions about general health.
Monthly visits for education and counseling
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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Lauren T Ptomey, Joseph E Donnelly, Jeffery Burns...
https://pubmed.ncbi.nlm.nih.gov/40329624/University of Kansas Medical Center
Lead Sponsor