Recruiting

Nutritious Foods

Sponsor:

University of Washington

Code:

NCT06870578

Conditions

Gliosis

Child Obesity

Eating

Eligibility Criteria

Sex: All

Age: 9+

Healthy Volunteers: Accepted

Interventions

Diet modification

Study Details

Brief summary:

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.

Conditions

Gliosis

Child Obesity

Eating

Study ID

NCT06870578

Start date

Apr 3, 2025

Status verified date

Jun, 2025

Completion date

Jun, 2029

Anticipated

Primary completion date

Jun, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 9+

Healthy Volunteers: Accepted

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 Design

Enrollment

75 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

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.

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.

Interventions

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.

Primary outcome measure

  • T2 relaxation time by brain MRI [ Time Frame: 7 days of diet intervention ]

Central Contacts and Locations

Central contacts

BRIDGE Study

206 616-6360bridge-study@uw.edu

Locations

University of Washington

Recruiting

Seattle, Washington, United States, 98109

Contacts

BRIDGE Study

206-616-6360bridge-study@uw.edu

More Information

Sponsor

University of Washington

Last update posted

Jun 6, 2025

Last verified

Jun, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Washington on 2025-06-06.