Healhty
Conditions
Keywords
eating behavior, BMI, Children, Satiety, Body composition
Brief summary
Background: Childhood obesity is a multifactorial health condition associated with profound metabolic, psychosocial, and socioeconomic ramifications across the lifespan. Among eating behaviors associated with obesity, limited attention has been given to chewing and food texture as pathways that may influence energy intake and weight regulation. Existing pediatric research remains scarce, methodologically heterogeneous, and often inconclusive. Aims: This study aims to examine associations between oral processing behaviors during a standardized meal, including eating duration, eating rate, Ghrelin levels, and anthropometric measures in healthy children. Methods: Participants responding to public advertisements will be screened for eligibility, including age (6-11 years), health status, absence of food allergies or intolerances, dental or developmental problems, and measured weight and height to achieve a sample of 40 children with obesity and 40 with normal weight. In a randomized crossover design, participants will consume two isocaloric, non-processed test meals differing in food texture (soft vs. hard) during separate laboratory visits. Eating behavior will be objectively assessed using a Universal Eating Monitor with synchronized video analysis to quantify chewing time, number of chews, and eating rate. Salivary ghrelin, subjective satiety (measured using visual analog scales), and total daily energy intake (assessed via 24-hour dietary recall) will be evaluated, along with anthropometric, body composition, strength measures, and sociodemographic and behavioral data. To account for familial and shared environmental influences on eating behavior, at least one parent will undergo a parallel assessment, conducted separately from the participating child. Participants will receive a modest shopping voucher to facilitate retention. Associations between oral processing behaviors, physiological responses, and weight status will be examined using multivariable regression models. Exploratory mediation analyses will be conducted to assess whether ghrelin and satiety responses partially account for the observed associations.
Detailed description
Objectives Primary Objective: To examine whether there is an association between the eating duration of a standard meal and weight status (as BMI Z-score) among children aged 6-11. Secondary Objectives: 1. To determine whether there is an association between the number of chews of a standard meal and the weight status of children aged 6-11. 2. To examine whether there is an association between chewing rate (total weight of food consumed/total eating time) during a standard meal and daily energy intake among children. 3. To examine whether there is an association between chewing rate during a standard meal and body composition among children. 4. To examine whether there is an association between the eating duration of a standard meal and the reported satiety level of children aged 6-11. 5. To examine whether there is an association between the eating duration of a standard meal and total daily energy intake. 6. To assess whether the associations between chewing behaviors, eating characteristics, and dietary intake differ between boys and girls. 7. To assess the relationship between chewing-related behaviors and salivary ghrelin responses before and after meal consumption. Study Design and Methodology Study Design: This doctoral project is a randomized, crossover, laboratory-based experimental study conducted among healthy children aged 6-11 years. Participants will attend multiple assessment sessions during which they will consume standardized isocaloric test meals differing only in food texture and chewability characteristics. The crossover design enables within-subject comparison of oral processing responses under different meal conditions while reducing inter-individual variability. All experimental sessions will be conducted under standardized laboratory conditions. Study Population: The study will include approximately 70 children aged 6-11 years, including those with normal weight and those with obesity, according to World Health Organization BMI-for-age z-score criteria. Children with medical conditions or dietary restrictions that may affect eating behavior, appetite regulation, or food consumption will be excluded. The selected age range represents a critical developmental stage during which eating patterns, satiety regulation, and obesity-related behaviors may still be influenced through behavioral and nutritional interventions. Primary Outcomes: Primary oral processing variables will include: Chewing duration; Number of chews; Eating duration; Eating rate; Amount of food consumed. Secondary Outcomes: 1\. Satiety Assessment: Subjective hunger and satiety responses will be evaluated using validated Visual Analog Scale (VAS) ratings before the meal, immediately after the meal, and during the postprandial period. Hormonal Assessment: Salivary ghrelin concentrations will be measured before and after test meals using standardized saliva collection and biochemical analysis procedures. Ghrelin was selected due to its established role in appetite regulation and meal-related hunger signaling. Methods Study Procedure: Participants will consume standardized test meals developed to differ in texture and chewability while maintaining comparable caloric and macronutrient composition. Meals will include foods categorized according to oral processing difficulty and chewing demands. During meal consumption, oral processing behaviors will be objectively assessed using synchronized behavioral and physiological measurement systems. To account for familial and shared environmental influences on eating behavior, at least one parent will undergo a parallel assessment, conducted separately from the participating child. Meal consumption will be recorded using panoramic video cameras, and chewing-related behaviors will be coded by independent evaluators. In addition, meals will be administered using the Universal Eating Monitor (UEM), a concealed scale-based system that continuously records food intake throughout the meal and enables high-resolution assessment of eating microstructure. Anthropometric and Body Composition Assessment: Children and parents will undergo standardized measurements of: Weight and height; BMI-for-age z-score/Parental BMI; Body composition using InBody 770; Upper-body muscle strength using JAMAR dynamometry. Dietary and Behavioral Questionnaires: Additional assessments will include: 24-hour dietary recalls; Physical activity questionnaires; Sociodemographic questionnaire; Children's Eating Behavior Questionnaire (CEBQ) (children only); AUT-EAT questionnaire (to assess eating behaviors and challenges specifically in children on the Autism Spectrum) (children only); parental eating behaviors questionnaire. Parents weight, height and eating behaviors will be recorded during one meal session. Statistical Analysis: Statistical analyses will be conducted using IBM SPSS Statistics, version 31.0. Descriptive statistics will summarize participant characteristics overall and by weight-status group. Continuous variables will be assessed for normality and presented as means ± SD or medians and interquartile ranges, as appropriate; categorical variables will be presented as frequencies and percentages. Group comparisons will be performed using t tests, Mann-Whitney U tests, chi-square tests, or Fisher's exact tests, as appropriate. Given the randomized crossover design, primary analyses will use linear mixed-effects models to account for repeated measurements within participants across meal conditions. Models will include participant as a random effect and meal texture, weight status or BMI-for-age z-score, visit order, and relevant covariates, including age, sex, and socioeconomic characteristics, as fixed effects. Interaction terms will be used to examine whether responses to soft versus hard meals differ by weight status or sex. Primary behavioral outcomes, including eating duration, chewing duration, number of chews, eating rate, and food consumed, will be analyzed in relation to BMI-for-age z-score, body composition, satiety ratings, ghrelin responses, and total daily energy intake. Satiety and salivary ghrelin changes will be examined using repeated-measures models and pre-to-post meal change scores. Parent-child associations in eating behaviors and anthropometric measures will be explored using correlation and regression analyses. Exploratory mediation analyses will assess whether satiety and ghrelin responses partially explain associations between oral processing behaviors and weight-related outcomes. Model assumptions will be evaluated, and sensitivity analyses will be conducted for missing or extreme values. Statistical significance will be set at p \< 0.05, with effect sizes and 95% confidence intervals reported alongside p values.
Interventions
OTHERTest meal B
A standardized Mediterranean-style breakfast consisting of bread, a thin omelet, grated carrot, sliced cucumber, apple purée, and a banana.
OTHERTest meal A
A typical Medittarenean breakfast with a soft texture including: Bread, flat omlet, grated carot, sliced cucamber, apple puree and a banana
Sponsors
Ariel University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Outcomes Assessor)
Masking description
Because the test meals differ in appearance and composition, participants and personnel administering the meals cannot be masked. Outcome assessors will remain unaware of the test-meal allocation. Study visits, samples, and outcome data will be identified using coded labels that do not disclose the meal type, and assessors will not have access to the allocation key until outcome assessment and data entry have been completed.
Intervention model description
The study is a crossover trial and all outcomes will be compared between each meal and every other meal. The meal order will be random. Meals will be similar in energy content and differ by the level of chewiness. Each test meal will be served at a different visit to the study laboratory, separated by a week to two weeks from the prior visit. Parents will complete sociodemographic, physical activity, regarding themselves and their children, anthropometrics, salivary Ghrelin and VAS for hunger. Additionally, the child's CEBQ and parent and child food intake over the past 24 hours will be recorded through an in-person interview. Following these assessments, the child and parent will receive their first test meal. The second meeting will be scheduled within two weeks of the first meeting, on a different weekday, to introduce variability in the 24-hour food recall data. The second test meal will be given. All meals will be weighed using UEM and the visit will be audio and video recorded
Eligibility
Sex/Gender
ALL
Age
6 Years to 11 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy children aged 6-11 years and their parents who are fluent in Hebrew or English.
Exclusion criteria
* Children with dietary restrictions due to medical indications, such as celiac disease, inflammatory bowel disease, or other health conditions that may affect their ability to accept identical test meals included in the research. * Children who are treated with medications for ADD or ADHD. * Children with recent tooth loss or an oral injury that interferes with their ability to chew or eat normally at the time of assessment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total energy intake during a meal | During each test meal, from placement of the meal tray on the table until the participant indicates that they have finished eating and leaves the table (approximately 5-20 minutes; assessed once per test meal). | Total energy intake at each meal will be calculated by weighing each food item before and after the meal and determining the energy content of the amount consumed. |
| Eating duration (minutes and seconds) | Measured during each test meal | Overall time the participant was eating the test meal. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total daily energy consumed | During the 24 hours preceding each of the two test-meal visits. | otal energy intake during the 24 hours preceding each test meal will be estimated separately using participant- and parent-reported consumption of all foods and beverages. Reported quantities will be converted to energy values (kcal) using a nutritional composition database and summed to calculate total 24-hour energy intake. |
| Satiety assessment | Subjective hunger and satiety responses will be evaluated before each test meal, immediately after the meal, and during the postprandial period. | Satiety will be assessed using validated Visual Analog Scale (VAS) ratings |
| Postprandial Change in Salivary Ghrelin Concentration | Immediately before and immediately after each of the two test meals. | Salivary ghrelin concentration will be measured using standardized saliva collection and biochemical analysis procedures. The outcome will be calculated as the change in ghrelin concentration from before to after each test meal and reported in pg/mL. |
| Total numbers of bites | During each test meal, from placement of the meal tray on the table until the participant indicates that they have finished eating and leaves the table (approximately 5-20 minutes; assessed once per test meal). | The total number of bites taken during each test meal will be determined through standardized review and coding of the video recording. A bite will be defined as an occasion on which food enters the participant's mouth. |
| Total number of chews | During each test meal, from placement of the meal tray on the table until the participant indicates that they have finished eating and leaves the table (approximately 5-20 minutes; assessed once per test meal). | The total number of chewing cycles performed during each test meal will be determined through standardized review and coding of the video recording. A chewing cycle will be defined as one complete jaw-closing movement associated with food mastication. |
Countries
Israel
Outcome results
None listed