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Behavioural Intervention
Diet Modification for Childhood Obesity (BRIDGE Trial)
Seattle, WA
N/A
Waitlist Available
Led By Ellen Schur, MD
Research Sponsored by University of Washington
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Study 2: Age 9-11y, BMI ≥85th and ≤95th percentile for age and sex
Must not have
History of major weight loss or eating disorder
Significant health conditions including type 2 diabetes
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to use MRI to see how healthy foods affect inflammation in the brain of children and to test if feeding them nutritious foods can help with weight issues.
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Who is the study for?
This trial is for children with overweight or obesity issues. It aims to study the impact of nutritious foods on brain inflammation and test if kids will accept healthy eating habits. Participants must be willing to undergo MRI scans.Check my eligibility
What is being tested?
The intervention being tested is a diet modification plan focused on nutritious foods. The study involves MRI scans to observe changes in brain inflammation, specifically in the hypothalamus, related to dietary changes.See study design
What are the potential side effects?
Since this trial involves diet modification as an intervention, side effects may include initial discomfort adjusting to new foods, potential digestive changes, and possible food cravings or aversions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 9-11 years old with a BMI between the 85th and 95th percentile.
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Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had significant weight loss or an eating disorder.
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Select...
I have type 2 diabetes.
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Select...
I am currently taking medication that can change my appetite or weight.
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Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Study-provided food (Study 2)Experimental Treatment1 Intervention
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.
Group II: Focus Group and Child Taste Test (Study 1)Active Control1 Intervention
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.
Group III: Focus Group (Study 3)Active Control1 Intervention
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.
Find a Location
Closest Location:University of Washington· Seattle, WA
Who is running the clinical trial?
University of WashingtonLead Sponsor
1,853 Previous Clinical Trials
2,021,786 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,983 Previous Clinical Trials
47,867,117 Total Patients Enrolled
Ellen Schur, MDPrincipal InvestigatorUniversity of Washington