Asociación Navarra de Pediatría
Pamplona, Navarre, 31002, Spain
NCT Number: NCT06828367
Questions:
* What's the effect of an online nutritional educational program in preschoolers families on the adherence to the mediterranean diet? * What's the effect of this program on the BMI at 3 years follow-up?
Study Description A randomized controlled experimental study with cohorts will analyze the effect of an online family educational intervention program on the weight status and adherence to the Mediterranean diet of children in early childhood education centers. It will be conducted in the municipal early childhood education centers of Pamplona, which already offer healthy and sustainable menus. In addition to evaluating the post-intervention effect, a follow-up will be conducted 2-3 years after the intervention to analyze its effect on the rate of overweight and obesity at 5-6 years of age.
Interested in participating?
Request Info18 month–36 month
All sexes
Interventional
Not applicable
Pamplona, Navarre, 31002, Spain
This is a randomized controlled experimental study with cohorts. The study will be carried out in the 10 municipal early childhood education centers in Pamplona (a city with 250,000 inhabitants, in an urban environment), which have around 900 children aged 0-3 years enrolled for the 2023-2024 school year. A follow-up will also be conducted 2-3 years after the study concludes (when participants are 5-6 years old).
The 10 participating centers will be randomized into intervention and control groups in a 1:1 ratio (5 centers in the control group and 5 centers in the intervention group), considering the socioeconomic level of the neighborhood where they are located. The educational program will be offered to families of children aged 18 to 36 months (the last year in the early childhood education center) attending schools in the intervention group. In the control group, participants will receive "usual care."
The educational program will be available on an online platform and will include content such as videos, documents, guides, games, etc., explaining nutritional information and other lifestyle topics. Additionally, there will be a cooking workshop (either in person or online). The educational program has been developed by nutritionists, pediatricians, and researchers and includes:
There will be two intervention waves over two consecutive school years. In the first wave (2023-2024), some schools will be in the intervention group and others in the control group, and in the next school year (2024-2025), the intervention and control groups will switch. Since the intervention is exclusive to the final year, there is no possibility for a participant from one group to participate in the other group the following year; participants are at all times new to the study.
The estimated study duration is 6 years, organized by school years:
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Registration for the educational platform will be open for 3 months from the start of the school year. Over the first 2-3 months, the contents of each topic will be activated weekly, and family participation will be encouraged through reminders. In the following 3 months, the platform will remain open, allowing families who did not follow the weekly content to catch up. Participation reminders will continue. From the 3rd to 6th month, the cooking workshop will be held in person. Throughout the intervention, activities will promote participation, and a Q&A channel with an expert (nutritionist) will remain open. Total intervention time: 6 months.
Time frame: Before and through intervention completion, an average of 6 months, and at 3 years of follow-up (5-6 years old).
Continuous and categorical variable, categorized according to age. Calculated from anthropometric data (weight and height), sex, and birthdate using WHO standards: >2 SDS (obesity), 1-2 SDS (overweight).
Time frame: Measurements: Before and through intervention completion, an average of 6 months and at 3 years of follow-up (5-6 years old), with parents reporting on the child's diet.
Mediterranean Diet Quality Index in children and adolescents. KIDMED score. A 16-question questionnaire with two possible answers (yes/no) that scores adherence to the Mediterranean diet from -4 to 12. Continuous and categorical variable. Categorized into 3 levels: <3: Low, 4-7: Medium, >8: High.
Time frame: Measurements: Before and through intervention completion, an average of 6 months, and at 3 years of follow-up (5-6 years old), with parents reporting on their own feeding style.
The Caregiver's Feeding Styles Questionnaire (CFSQ) consists of 19 items with Likert-type responses ranging from 1 (never) to 5 (always). The items are grouped into two dimensions: demand and responsibility. To calculate the demand score, the average of the sum of the 19 items is calculated and responsibility is the average of the sum of 7 items focused on the child (3, 4, 6, 8, 9, 15 and 17) divided by the average of the sum of the 19 items. The average of both dimensions is then calculated in this population and participants are categorized into high/low demand and high/low responsibility and are classified into four styles:
Time frame: Measurements: Before and through intervention completion, an average of 6 months, and at 3 years of follow-up (5-6 years old), with parents reporting on the child's physical activity.
The International Fitness Scale (IFIS) is scored using a 5-point Likert scale for each of the five items that assess adolescents' self-perceived physical fitness: overall fitness, cardiorespiratory fitness, muscular fitness, speed-agility, and flexibility. The response categories are: Very poor, Poor, Average, Good, and Very good.
Scoring Method:
Possible Categories:
Time frame: Measurements: Before and through intervention completion, an average of 6 months, and at 3 years of follow-up (5-6 years old), with parents reporting on the child's overall diet.
Food Consumption Frequency Questionnaire. Consists of 53 (47 + 6) multiple-choice questions on weekly/monthly consumption frequency of various foods to assess the child's diet.
No cumulative total score: The Food Consumption Frequency Questionnaire does not propose a system for summing the scores of the items into a single total score. Instead, each component is analyzed separately
Time frame: Only at enrollment
Sociodemographic variables for parents: age, race (1: Caucasian, 2: Hispanic, 3: African American, 4: Asian, 5: Other), education level (1: Secondary education or equivalent, 2: Vocational training, high school or equivalent, 3: University), employment status (1: Stable, 2: Partial/unstable, 3: Unemployed), socioeconomic level - income per capita (> 15,000, 6,650 - 15,000, < 6,650).
Time frame: Before and through intervention completion, an average of 6 months, and at 3 years of follow-up (5-6 years old).
Weight in kilograms and height in meters will be collected from primary healthcare records, as documented by healthcare professionals (pediatricians or nurses) who are not part of the research team.
Body Mass Index (BMI): weight and height will be combined to report BMI in kg/m^2.
Time frame: Only at enrollment
Duration of breastfeeding (months).
Time frame: Only at enrollment
Age of introduction to complementary feeding (puree, solid food) (months)
Time frame: Before and through intervention completion, an average of 6 months, and at 3 years of follow-up (5-6 years old).
Quantity of mashed food in diet (3 levels: <10%, 10-50%, >50%)
Time frame: Before and through intervention completion, an average of 6 months, and at 3 years of follow-up (5-6 years old).
Use of screens (TV, tablet, mobile phone, etc.) while the child is eating. 5 levels (1: never, 2: rarely, 3: sometimes, 4: frequently, 5: always)
Fundacion Miguel Servet
Other
EFFECT OF THE IMPLEMENTATION OF A HEALTHY MENU AND A NUTRITION EDUCATION PROGRAM IN PRESCHOOLER'S FAMILIES ON THEIR ADHERENCE TO THE MEDITERRANEAN DIET. ELIKUME PROJECT
Acronym: ELIKUME
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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