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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Weight Loss | Experimental |
|
|
| General Health Education Control | Active Comparator | - Attend monthly health education sessions about general health. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diet | Behavioral | A reduced calorie diet which uses frozen meals purchased at the store and focuses on increasing fruits and vegetables associated with brain health. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Plasma Amyloid beta 42:40 ratio | Examines the amount of amyloid beta in a person's brain, measured by a blood draw. | Baseline, 6, 12 months |
| Neurofilament light | Examines the amount of Neurofilament light in a person's brain, measured by a blood draw. | Baseline, 6, 12 months |
| Weight | Examines how much a person weights, measured by standing on a scale. | Baseline, 6, 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Dietary Intake | Examines what someone is eating, measured by writing down what a person eats over 3 days. | Baseline, 6, 12 months |
| Skin carotenoid content | Examines how many vegetables a person eats, measured by a finger scan using the Veggie Meter. |
| Measure | Description | Time Frame |
|---|---|---|
| Height | Examines how tall a person is, measured on a stadiometer | Baseline, 6, 12 months |
| Waist circumference | Examines the distance around the smallest part of a person's torso, measured with a measuring tape |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lauren Ptomey, PhD | Contact | 913-588-7982 | lptomey@kumc.edu | |
| Jessica Danon | Contact | 785-764-3574 | jdanon@kumc.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kansas Medical Center | Recruiting | Kansas City | Kansas | 66160 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40329624 | Derived | Ptomey LT, Donnelly JE, Burns J, Morris J, Hartley S, Martin LE, Choi IY, Lee P, Li Y, Hunt S, Sherman JR, Danon JC, Brucks MG, Koon L, Spaeth K, Sullivan DK. Brain outcomes with lifestyle change in adults with Down syndrome: Rationale and design for a 12-month randomized trial. Alzheimers Dement. 2025 Apr;21(4):e70219. doi: 10.1002/alz.70219. |
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| ID | Term |
|---|---|
| D004314 | Down Syndrome |
| D000544 | Alzheimer Disease |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D008607 | Intellectual Disability |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D004032 | Diet |
| ID | Term |
|---|---|
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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| Health Education | Behavioral | Monthly health education sessions delivered remotely. |
|
| Baseline, 6, 12 months |
| Plasma Phosphorylated Tau | Examines the amount of Tau in a person's brain, collected by a blood draw. | Baseline, 6, 12 months |
| Glial Fibrillary Acidic Protein | Examines the amount of Glial Fibrillary Acidic Protein in a person's brain, collected by a blood draw. | Baseline, 6, 12 months |
| Brian Volume | Examines how much white and grey matter a person has in their brain, measured by MRI | Baseline, 12 months |
| Brain antioxidants | Examines the amount of GHS and vitamin C a person has in their brain. Measured by MRI | Baseline, 12 months |
| The modified Cued Recall Test | Measures cognitive function. Twelve items are presented for learning, 4 at a time, with each item accompanied by a unique category cue. The testing phase consists of 3 trials. Each trial begins with free recall of the test items; following free recall, a category cue is provided for those items not spontaneously recalled. | Baseline, 6, 12 months |
| The Modified Cats and Dogs Task | Measures executive function. The task measures the ability to inhibit a natural response (naming the pictures of a dog, as "dog") and to replace it with an incongruent one (naming the pictures of a dog as "cat"). | Baseline, 6, 12 months |
| Down Syndrome Mental Status Examination | Provides an omnibus measure of neuropsychological functioning, assessing recall of personal information, orientation, immediate and delayed memory, language, visuospatial function and praxis. | Baseline, 6, 12 months |
| Baseline, 6, 12 months |
| Attendance at education sessions | Examines how often individuals attendance the monthly education sessions. Obtained from interventionist records and expressed as the percentage of possible sessions attended. | Across 12 months |
| Compliance with self-monitoring of diet | Assessed as the percentage of days a person tracked what they ate across the study. | Across 12 months |
| Physical Activity | Examines Daily minutes of light, moderate, and vigorous physical activity as well as sedentary time using an ActiGraph tri-axial accelerometer worn on a wrist for 7 days. | Baseline, 6, 12 months |
| Structured interviews | A 20% random sample of participants and study partners from each intervention arm will complete a 30 minute interview to gather information that might be useful for improving the intervention. | 12 months |
| D000015 | Abnormalities, Multiple |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D025063 | Chromosome Disorders |
| D030342 | Genetic Diseases, Inborn |
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |