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

Not Applicable

Not yet recruiting

• Conditions: Pediatric Obesity

• Registration Number: NCT07095166
• Lead Sponsor: Penn State University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-09
• Study First Submitted QC: 2025-07-23
• Last Update Submitted: 2025-07-23
• Study First Posted: 2025-07-31
• Last Update Posted: 2025-07-31
• Study Start: 2025-10-15
• Primary Completion: 2027-06-15
• Study Completion: 2027-10-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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

• they are not within the age requirements (<6 years old or > 9 years old)
• If they are taking cold or allergy medication, or other medications known to influence cognitive function, taste, appetite, or blood flow.
• If they don't speak English.
• If they are colorblind.
• If they have a learning disability, ADD/ADHD, language delays, autism or other neurological or psychological conditions.
• If they 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 they 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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Child body mass index	Day 1	child height and weight will be measured
Food intake in grams during a standard meal	Day 1 and Day 2 or 3 depending on randomization	Intake in grams from standard meal
Food intake in kcal during a standard meal	Day 1 and Day 2 or 3 depending on randomization	Intake in kcal during a standard meal
Video coding of standard meal	Day 1 and Day 2 or 3 depending on randomization	A digital recording of the child eating a standard meal will be saved. We have developed a behavior coding protocol to measure child meal microstructure (e.g., bites, bite size, meal duration). We 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 hungry	Day 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 hungry	Day 1	Intake in kcal during a snack buffet using a standard eating in the absence of hunger paradigm (i.e., non-homeostatic intake)
Food intake in grams during a Study Meal	Day 2 or 3 depending on randomization and home meal administration	Intake in grams from Study Meal
Food intake in kcal during the Study Meal	Day 2 or 3 depending on randomization and home meal administration	Intake in kcal during the Study Meal
Video coding of the study meal	Day 2 or 3 depending on randomization and home meal administration	! digital recording of the child eating a Study Meal will be saved. We have developed a behavior coding protocol to measure child meal microstructure (e.g., bites, bite size, meal duration). We have also validated a computational model to assess cumulative intake curves from video coded bite data.
Body Composition	Day 1	Dual-energy X-ray absorptiometry to assess body composition including fat mass and fat-free mass in children
Video coding of home meals	Week 1 and Week 2	Digital recordings of the child eating a typical meals at home. We have developed a behavior coding protocol to measure child meal microstructure (e.g., bites, bite size, meal duration). We have also validated a computational model to assess cumulative intake curves from video coded bite data.