Building Research for Intervention Development in Gliosis and Eating Habits
Purpose
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
Eligibility
- Eligible Ages
- Over 9 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- Yes
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
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Non-Randomized
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Basic Science
- Masking
- Single (Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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. |
|
Recruiting Locations
Seattle, Washington 98109
More Details
- NCT ID
- NCT06870578
- Status
- Recruiting
- Sponsor
- University of Washington