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

University of Washington

Status: Enrolling

Conditions: Eating; Child Obesity; Gliosis

Treatments: Other: Diet modification

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06870578

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

STUDY00020281

Details and patient eligibility

About

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.

Enrollment: 75 estimated patients

Sex: All

Ages: 9+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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75 participants in 3 patient groups

Focus Group and Child Taste Test (Study 1)

No Intervention group

Description:

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.

Study-provided food (Study 2)

Experimental group

Description:

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.

Treatment:

Other: Diet modification

Focus Group (Study 3)

No Intervention group

Description:

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.