A Multifaceted Assessment of Eating Behaviors, Anthropometric Measurements and Body Composition in Pediatric Patients With Drug-resistant Epilepsy on a Ketogenic Diet and Healthy Children
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 150
- Locations
- 2
- Primary Endpoint
- Comparison of frequency and severity of food neophobia between groups, based on the Modified CFNS.
Study Overview
Brief Summary
The goal of this observational study is to compare the prevalence and severity of eating behaviors-such as food neophobia, picky eating, food fussiness, meal repetition and variety, and food texture preferences-between healthy children and children with drug-resistant epilepsy on a ketogenic diet. It will also compare anthropometric measurements, body composition, and resting metabolic rate (RMR) between the groups. The study seeks to identify key aversive eating behaviors that could potentially affect diet quality.
Participants-children already following the ketogenic diet-will answer questionnaires about eating behaviors and be measured (weight, height, skinfold thickness, and resting metabolic rate). Parents will also answer questionnaires about their children's eating behaviors. Researchers will compare eating behaviors and anthropometric measurements with those of healthy children.
Detailed Description
It is planned to measure the participants' height and weight. The following measurements will be taken among the study participants: height, using a free-standing, portable Tanita HR-001 (Tanita, Tokyo, Japan) stadiometer, and weight, using a Tanita BC 545 scale (Tanita, Tokyo, Japan). Additionally, the thickness of skinfolds above and below the biceps, below the shoulder blade (subscapular), and above the iliac crest (suprailiac) will be measured. Furthermore, calf, arm, and waist circumferences will be measured.
Based on the data obtained, BMI will be calculated and compared against the OLA and OLAF percentile growth charts dedicated to the Polish pediatric population. As recommended, <5th percentile will be adopted as underweight, 5th-85th percentile as normal weight, >85th percentile as overweight, and >95th percentile as obesity.
Furthermore, based on body weight, circumference, and skinfold thickness, an assessment of body fat content is planned.
To assess dietary habits, parents and children from both the study and control groups, together with a qualified dietitian, will complete the following questionnaires: the Modified Children's Food Neophobia Scale (Modified CFNS) (parent), the Children's Eating Behavior Questionnaire (CEBQ) (parent), and the Child Food Texture Preference Questionnaire (CFTPQ) (child), translated into Polish.
To supplement information regarding dietary style, the authors will ask parents of children from both the study and control groups additional questions concerning meal variety, meal repetitiveness, and the occurrence of periods of selective eating. The obtained data will be statistically processed and used to create scientific publications.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 2 Years to 15 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •, studied group:
- •consent of the child and guardians/caregivers to participate in the study,
- •diagnosis of drug-resistant epilepsy and use of a ketogenic diet for at least 3 months,
- •age above 2 years, full or partial use of an oral diet (to an extent that allows the child to express their food preferences)
- •possibility of measuring RMR via indirect calorimetry
Exclusion Criteria
- •, studied group :
- •lack of consent from the child and guardians/caregivers to participate in the study
- •non-adherence to ketogenic diet recommendations,
- •100% nutrition supply via PEG (n=2),
- •age below 2 years (n=2)
- •treatment at a clinical center other than the Lower Silesian one
- •inability to perform anthropometric measurements and RMR
- •Inclusion Criteria, control group:
- •consent of the parent and child to participate in the study
- •absence of chronic diseases, no permanent use of medications
- •no diagnoses/certificates from a pedagogical-psychological counseling center, e.g., dyslexia, dysgraphia, social relationship disorders, no diagnoses such as Asperger's, Autism, or other spectrum disorders or nervous system function disorders
- •ability to perform anthropometric measurements
- •Polish citizenship and residence in Poland
- •residence in the Lower Silesia region.
- •Exclusion Criteria, control group:
- •lack of consent to perform/participate in the study
- •chronic diseases including neurological disorders, certificates and/or diagnoses from a psychological-pedagogical counseling center
- •use of specialized diets related to illness or exclusion diets (vegetarian, vegan, ketogenic diet)
- •chronic use of medications related to illness, inability to perform anthropometric measurements and RMR meaurements.
Outcomes
Primary Outcomes
Comparison of frequency and severity of food neophobia between groups, based on the Modified CFNS.
Time Frame: from enrollment to the end of data collection (03.2026)
For Modified Children's Food Neophobia Scale (Modified CFNS) the following cut-off values were adopted to indicate the presence and/or severity of neophobia: * Values \>12 points were considered indicative of a higher degree of food neophobia, and ≤12 points as a lower level of food neophobia. Following other authors, values above M+1SD were adopted as indicative of neophobia. The mean score values, as well as the percentages of children presenting higher and lower food neophobia, will be compared between groups.
Differences in resting metabolic rate values between healthy children and children on a ketogenic diet, based on indirect calorimetry and the percentage of predicted values according to theoretical RMR prediction equations
Time Frame: From enrollment to the end of data collection (03/2026)
The obtained RMR results from indirect calorimetry will be compared to standard RMR prediction equations for children, i.e., the Schofield equation, the FAO/WHO equation, and the equations developed by the Institute of Medicine of the National Academies and the Food and Nutrition Board, and expressed and compare as a percentage of their predicted values.
Comparison of frequency and severity of eating difficulties between groups, based on CEBQ.
Time Frame: from enrollment to the end of data collection (03.2026)
In Children's Eating Behavior Questionnaire (CEBQ) - the following cut-off values were adopted to indicate the presence and/or severity of eating behaviors: Score levels above 50% of a given subscale were assessed as indicating a higher representation of the corresponding eating style. Results above M±SD were set as indicating a strong representation of a given eating style among children. The frequency and severity of presented habits assessed in the questionnaire will be compared between groups.
Comparison of children's food texture preferences between groups, based on the CFTPQ.
Time Frame: from enrollment to the end of data collection (03.2026)
Based on results from The Child Food Texture Preference Questionnaire (CFTPQ) - Scores \<25th percentile classified children into the so-called "soft texture likers" group, while scores \>75th percentile classified children into the "hard texture likers" group. The percentages of children classified as so-called 'soft texture likers' and 'hard texture likers' will be compared between groups.
Secondary Outcomes
- Comparison of the nutritional status of the study group and the control group based on percentile values for height, weight, and BMI.(from enrollment to the end of data collection (03.2026))
- Comparison of percentage body fat content, based on skinfold thickness measurements, between the study group and the control group.(From enrollment to the end of data collection (03/2026))