Building Research for Intervention Development in Gliosis and Eating Habits (BRIDGE)

June 5, 2025 updated by: Ellen Schur, MD, MS, University of Washington

Fostering Patient-oriented Research in Cardiometabolic Disease Pathogenesis and Prevention

The goal of this study is to 1) use magnetic resonance imaging (MRI) to evaluate the effect of nutritious foods on inflammation in the human hypothalamus of children and 2) assess the feasibility and acceptability of nutritious food feeding intervention strategies in children with overweight or obesity.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98109
        • Recruiting
        • University of Washington
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Study1: Adult caregiver and Child age 9-11y. Willing to come to in-person focus group
  • 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 (study 1 child participants and study 3 criteria for children of adult participants):

  • 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
  • Severe food allergies, vegetarian, or vegan (Study 1 only)
  • Unable to make the session date

Exclusion Criteria (study 2, child participants):

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: 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.
Experimental: 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.
Other: 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.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
T2 relaxation time by brain MRI
Time Frame: 7 days of diet intervention
7 days of diet intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Washington

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

  • Principal Investigator: Ellen Schur, MD, University of Washington

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 3, 2025

Primary Completion (Estimated)

June 1, 2029

Study Completion (Estimated)

June 1, 2029

Study Registration Dates

First Submitted

February 28, 2025

First Submitted That Met QC Criteria

March 5, 2025

First Posted (Actual)

March 11, 2025

Study Record Updates

Last Update Posted (Actual)

June 6, 2025

Last Update Submitted That Met QC Criteria

June 5, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00020281
  • 2K24HL144917 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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