Clinical trial

Monitoring Eating Across Locations (MEAL) - Timing, Intake, and Mealtime Evaluation (TIME)

Recruiting now · Not applicable · 1 countries · Registry ID NCT07095166

Recruiting nowNot applicableInterventional

What this study is about

Increased availability of high-energy dense foods has contributed to a pediatric obesity epidemic, with 23% of United States children currently presenting with the disease. How children eat contributes to both overconsumption and greater adiposity. However, it is unclear if laboratory measures of children's eating style generalize to the home environment, where children consume two thirds of their total energy. The study will 1) test if child eating styles observed in the lab generalize to more ecologically valid home environments and 2) identify aspects of home food environment that amplify obesogenic eating behaviors. We will assess laboratory and home eating styles (e.g., bite rate) in 100 prepubertal 6-9-year-old children to constrain variability in energy requirements. Children will be video-recorded while consuming identical study-provided meals at home and in the laboratory (counter-balanced order) in addition to a 'typical' meal at home. To study how adiposity relates to "obesogenic" styles of eating, gold standard dual x-ray absorptiometry will be used.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age6 Years to 9 Years
SexAll
Healthy volunteersAccepted
ConditionPediatric Obesity

Full registry criteria

Inclusion Criteria: * children must be between the ages of 6-9 years-old * children are of good health with no learning disabilities (e.g., ADHD, determined by parent report) * children are not on any medications known to impact body weight, taste, food intake, behavior, or blood flow * parents report that children like and are willing to eat study foods Exclusion Criteria: * Children are not within the age requirements (\<6 years old or \> 9 years old) * If children are taking cold or allergy medication, or other medications known to influence cognitive function, taste, appetite, or blood flow. * If children don't speak English. * If children are colorblind. * If children have a learning disability, ADD/ADHD, language delays, autism or other neurological or psychological conditions. * If children have a pre-existing medical condition such as type I or type II diabetes, rheumatoid arthritis, Cushing's syndrome, Down's syndrome, severe lactose intolerance, Prader-Willi syndrome, HIV, cancer, renal failure, or cerebral palsy. * If children are allergic to foods or ingredients used in the study. * child received an X-ray in the previous year (to avoid excess radiation exposure due to the DXA scans performed in the research)

Treatments and study arms

Meal Location

Behavioral

The location at which the child will eat the experimental meal - home or lab

Primary outcomes

Child body mass indexDay 1

child height and weight will be measured

Food intake in grams during a standard mealDay 1 and Day 2 or 3 depending on randomization

Intake in grams from standard meal

Food intake in kcal during a standard mealDay 1 and Day 2 or 3 depending on randomization

Intake in kcal during a standard meal

Video coding of standard mealDay 1 and Day 2 or 3 depending on randomization

A digital recording of the child eating a standard meal will be saved. The study team have developed a behavior coding protocol to measure child meal microstructure (e.g., bites, bite size, meal duration) and have also validated a computational model to assess cumulative intake curves from video coded bite data.

Food intake in grams during a snack buffet when not hungryDay 1

Intake in grams during a snack buffet using a standard eating in the absence of hunger paradigm (i.e., non-homeostatic intake)

Food intake in kcal during a snack buffet when not hungryDay 1

Intake in kcal during a snack buffet using a standard eating in the absence of hunger paradigm (i.e., non-homeostatic intake)

Body CompositionDay 1

Dual-energy X-ray absorptiometry to assess body composition including fat mass and fat-free mass in children

Food intake in grams during a Study MealDay 2 or 3 depending on randomization and home meal administration

Intake in grams from Study Meal

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Pennsylvania State University🇺🇸 State College, Pennsylvania, United States
Alaina Pearce, PhDContact