BOLD: Brain Outcomes With Lifestyle Change in Down Syndrome
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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.
|
Outcome Measures
Primary Outcome Measures
- Plasma Amyloid beta 42:40 ratio [Baseline, 6, 12 months]
Examines the amount of amyloid beta in a person's brain, measured by a blood draw.
- Neurofilament light [Baseline, 6, 12 months]
Examines the amount of Neurofilament light in a person's brain, measured by a blood draw.
- Weight [Baseline, 6, 12 months]
Examines how much a person weights, measured by standing on a scale.
Secondary Outcome Measures
- Cognitive Function [Baseline, 6, 12 months]
Examines cognitive function measured using the National Alzheimer's Coordinating Center's DS Module.
- Brian Volume [Baseline, 6, 12 months]
Examines how much white and grey matter a person has in their brain, measured by MRI
- Brain antioxidants [Baseline, 6, 12 months]
Examines the amount of GHS and vitamin C a person has in their brain. Measured by MRI
- Dietary Intake [Baseline, 6, 12 months]
Examines what someone is eating, measured by writing down what a person eats over 3 days.
- Skin carotenoid content [Baseline, 6, 12 months]
Examines how many vegetables a person eats, measured by a finger scan using the Veggie Meter.
- Plasma Phosphorylated Tau [Baseline, 6, 12 months]
Examines the amount of Tau in a person's brain, collected by a blood draw.
- Glial Fibrillary Acidic Protein [Baseline, 6, 12 months]
Examines the amount of Glial Fibrillary Acidic Protein in a person's brain, collected by a blood draw.
Other Outcome Measures
- Height [Baseline, 6, 12 months]
Examines how tall a person is, measured on a stadiometer
- Waist circumference [Baseline, 6, 12 months]
Examines the distance around the smallest part of a person's torso, measured with a measuring tape
- Attendance at education sessions [Across 12 months]
Examines how often individuals attendance the monthly education sessions. Obtained from interventionist records and expressed as the percentage of possible sessions attended.
- Compliance with self-monitoring of diet [Across 12 months]
Assessed as the percentage of days a person tracked what they ate across the study.
- Physical Activity [Baseline, 6, 12 months]
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.
- Structured interviews [12 months]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Diagnosis of Down syndrome
-
BMI of 25 to 45 kg/m2
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Ability to communicate through spoken language.
-
Ability to come to the University of Kansas Medical Center 3 times across 1 year for outcomes testing
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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:
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Diagnosis of dementia
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Insulin dependent diabetes
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Participation in a weight management program involving diet or physical activity in the past 6 mos.
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Dairy allergy
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Serious medical risk (e.g., cancer, recent heart attack, stroke, pregnancy, angioplasty)
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Unwilling to be randomized
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Contraindications for MRI, including metal implants or devices incompatible with MRI such as pacemakers, claustrophobia, and inability to lay in a supine position
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Kansas Medical Center | Kansas City | Kansas | United States | 66160 |
Sponsors and Collaborators
- University of Kansas Medical Center
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Study 150542