Building Research for Intervention Development in Gliosis and Eating Habits
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age9+
SponsorUniversity of Washington
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Diet modification
Other interventionIn 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.
Treatment groups
75 Participants
are divided into 3 treatment groupsGroup A: Focus Group and Child Taste Test (Study 1)No intervention 0 interventions
Group B: Study-provided food (Study 2)Experimental treatment 1 intervention
Group C: Focus Group (Study 3)No intervention 0 interventions
Trial outcomes
Primary outcomes
1
T2 relaxation time by brain MRI
Time frame
7 days of diet interventionSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Washington
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
Source ClinicalTrials.gov