Building Research for Intervention Development in Gliosis and Eating Habits
NCT ID: NCT06870578
Last Updated: 2025-06-06
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
75 participants
INTERVENTIONAL
2025-04-03
2029-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
BASIC_SCIENCE
SINGLE
Study Groups
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Focus Group and Child Taste Test (Study 1)
No intervention is administered. Adult caregivers will participate in a focus group to assess feasibility of a controlled feeding study in children and children will complete a taste-test of a controlled feeding study menu.
No interventions assigned to this group
Study-provided food (Study 2)
Participants will be provided all meals for a 7-day period. For the other 7-days of their enrollment, they will be asked to consume their usual diet.
Diet modification
In Study 2 only, children will be provided all meals for a 7-day period. Meals will consist of nutritious foods, calories provided will exceed the child's estimated daily caloric need, and children will be asked to consume meals ad libitum.
Focus Group (Study 3)
No intervention is administered. Adult caregivers of children will participate in a focus group to learn from families about participating in research involving feeding studies in children.
No interventions assigned to this group
Interventions
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Diet modification
In Study 2 only, children will be provided all meals for a 7-day period. Meals will consist of nutritious foods, calories provided will exceed the child's estimated daily caloric need, and children will be asked to consume meals ad libitum.
Eligibility Criteria
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Inclusion Criteria
* Study 2: Age 9-11y, BMI ≥85th and ≤95th percentile for age and sex
* Study 3:Adult caregiver with child who qualify for free or reduced-cost lunch in WA State. Child age 9-11y and with overweight.
Exclusion Criteria
* History of major weight loss or eating disorder
* Current use of medications known to alter appetite or body weight (e.g., stimulants for ADHD)
* Documented cognitive disorder
* Severe food allergies, vegetarian, or vegan (Study 1 only)
* Unable to make the session date
* Significant health conditions including type 2 diabetes
* History of major weight loss or eating disorder
* Current use of medications known to alter appetite or body weight (e.g., stimulants for ADHD)
* Documented cognitive disorder
* MRI contraindication (e.g., braces, claustrophobia)
* Weight \>330 pounds (MRI limit)
* Severe food allergies, vegetarian, or vegan
* Currently in formal weight loss program
9 Years
ALL
Yes
Sponsors
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National Heart, Lung, and Blood Institute (NHLBI)
NIH
University of Washington
OTHER
Responsible Party
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Ellen Schur, MD, MS
Professor: School of Medicine
Principal Investigators
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Ellen Schur, MD
Role: PRINCIPAL_INVESTIGATOR
University of Washington
Locations
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University of Washington
Seattle, Washington, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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STUDY00020281
Identifier Type: -
Identifier Source: org_study_id
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