Building Research for Intervention Development in Gliosis and Eating Habits

NCT ID: NCT06870578

Last Updated: 2025-06-06

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-03

Study Completion Date

2029-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Gliosis Child Obesity Eating

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Outcome Assessors

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.

Group Type NO_INTERVENTION

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.

Group Type EXPERIMENTAL

Diet modification

Intervention Type OTHER

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.

Group Type NO_INTERVENTION

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.

Intervention Type OTHER

Eligibility Criteria

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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

* 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


* 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
Minimum Eligible Age

9 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

University of Washington

OTHER

Sponsor Role lead

Responsible Party

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Ellen Schur, MD, MS

Professor: School of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status RECRUITING

Countries

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United States

Central Contacts

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BRIDGE Study

Role: CONTACT

206 616-6360

Facility Contacts

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BRIDGE Study

Role: primary

206-616-6360

Other Identifiers

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2K24HL144917

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00020281

Identifier Type: -

Identifier Source: org_study_id

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