The Association of Chewing and Eating Rate With Weight Status Among Children Aged 6-11 Years
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Total energy intake during a meal
研究概览
简要总结
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.
详细描述
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:
- 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.
- 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.
- To examine whether there is an association between chewing rate during a standard meal and body composition among children.
- 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.
- To examine whether there is an association between the eating duration of a standard meal and total daily energy intake.
- To assess whether the associations between chewing behaviors, eating characteristics, and dietary intake differ between boys and girls.
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 6 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy children aged 6-11 years and their parents who are fluent in Hebrew or English.
排除标准
- •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.
研究组 & 干预措施
Sequence A-B
Participants will receive Test Meal A during the first study visit and Test Meal B during the second study visit, following the specified washout period.
干预措施: Test meal B (Other)
Sequence A-B
Participants will receive Test Meal A during the first study visit and Test Meal B during the second study visit, following the specified washout period.
干预措施: Test meal A (Other)
Sequence B-A
Participants will receive Test Meal B during the first study visit and Test Meal A during the second study visit, following the specified washout period.
干预措施: Test meal B (Other)
Sequence B-A
Participants will receive Test Meal B during the first study visit and Test Meal A during the second study visit, following the specified washout period.
干预措施: Test meal A (Other)
结局指标
主要结局
Total energy intake during a meal
时间窗: 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)
时间窗: Measured during each test meal
Overall time the participant was eating the test meal.
次要结局
- Total daily energy consumed(During the 24 hours preceding each of the two test-meal visits.)
- Satiety assessment(Subjective hunger and satiety responses will be evaluated before each test meal, immediately after the meal, and during the postprandial period.)
- Postprandial Change in Salivary Ghrelin Concentration(Immediately before and immediately after each of the two test meals.)
- 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).)
- 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).)
研究者
Vered Kaufman Shriqui
Associate professor, Nutrition Sciences
Ariel University