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Prevention of Childhood ObesityELIKUMENCT06828367

EFFECT OF A ONLINE NUTRITION EDUCATION PROGRAM IN PRESCHOOLER'S FAMILIES ON THEIR ADHERENCE TO THE MEDITERRANEAN DIET

A study testing Online family educational intervention and cooking workshop in people with Prevention of Childhood Obesity and Community Health Education, run by Fundacion Miguel Servet at 1 site in Spain.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record

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Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 36 monthsHealthy volunteers can take part
What is being tested?
Online family educational intervention and cooking workshop
Could I receive a placebo?
No, everyone receives an active treatment
How many people
160 participants
Where
1 siteSpain
Study dates
1 Sep 2023to 31 Dec 2028
Phase
Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 36 months
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Families with children aged 18 to 36 months attending a municipal early childhood education center in Pamplona
  • Must be enrolled in a municipal early childhood education center in Pamplona
  • Must sign the informed consent
  • Must access the website and complete the initial questionnaire

Who cannot join

  • Families unable to understand the study or who do not speak the language well
  • Refusal to participate

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Spain1 site
  • Asociación Navarra de Pediatría

    Pamplona, Navarre, 31002

Other trials in Spain

About this study

Official title: 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

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.

Read the detailed description

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:

  • Presentation of the project
  • Self-assessment of nutrition knowledge: Online games about healthy plates, myths in children's nutrition, "How did you eat today?", True/False about organic foods
  • Guides for infant feeding: Recommendations for feeding in early childhood (0-3 years), healthy and sustainable meals for families
  • Attitudes: Psychologist's guidance on "picky eaters," educators
  • Grocery shopping: A guide for healthy vs. processed foods, sensory appreciation, and seasonal foods. Infographics on the benefits of ecologic shopping. Learning how to read food labels
  • Physical activity for families: The importance of active lifestyles and physical activity for family health. Ideas for healthy and fun family activities for various ages
  • Complementary materials
  • Question forum: Publishing the most frequently asked questions
  • Cooking workshops: Show-cooking with the culinary staff of the Pamplona municipal early childhood education centers. Recipe tutorials and cookbook. Educational materials on food waste, food storage, and preservation.

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:

  • Recruitment (start of the school year):
  • In the schools assigned to the intervention group at the beginning of the school year, families will be invited to participate in the study, and registration for new participants will be open for 3 months. The platform will be promoted via email, posters, involvement of educators, promotional activities, and the schools' websites. Upon accessing the platform, an initial questionnaire will be activated to collect data on the study variables. The online training will be available for 6 months for families, and a cooking workshop will be held during this period. After the intervention, a post-intervention questionnaire will be activated. Reminders will be sent by email, phone, and in person through the educators at the schools.
  • In the schools assigned to the control group, families will be invited to participate at the start of the school year, and registration for new participants will be open for 3 months. The platform will be promoted in the same way as for the intervention group. After 6 months, at the same time as the end of the intervention in the other group, the post-intervention questionnaire will be activated in the control group as well. Reminders will also be sent by email, phone, and in person.
  • Intervention: 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.
  • Study measures and methods pre and post intervention: Pre- and post-intervention questionnaires will be included on the platform. The platform will be used for both evaluations and the educational program for the intervention group. Reminders will be sent via email, phone, or in person at the early childhood education centers to ensure questionnaire completion.
  • Follow-up: Three years after the intervention (when participants are 5-6 years old), anthropometric data will be collected from routine check-ups at their healthcare center. At this time, a follow-up questionnaire will be sent to the families, covering KIDMED, CFSQ, IFIS, and food consumption frequency. The questionnaire will be sent by email to all participants.
  • Usual care: The control group will not have access to the educational program
Being tested
Online family educational intervention and cooking workshop
Keywords
Pediatric Obesity, Primary Prevention, Mediterranean Diet, Child Day Care Centers, Preschool Children, Mother-Child Relations
Medical subject headings
Health Education, Pediatric Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Online family educational intervention and cooking workshopBehavioural

    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.

Study groups in NCT06828367
Study groupRoleWhat they receive
InterventionExperimentalOnline family educational intervention and cooking workshop
Receives: Behavioral: Online family educational intervention and cooking workshop
ControlNo interventionUsual care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. BMI z-score

    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).

    Measured: Before and through intervention completion, an average of 6 months, and at 3 years of follow-up (5-6 years old).

  2. Adherence to Mediterranean 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.

    Measured: 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.

Secondary outcomes (3)
  1. Caregiver 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:

    1. Authoritative (high demand/high responsibility).
    2. Authoritarian (high demand/low responsibility).
    3. Indulgent (low demand/high responsibility).
    4. Uninvolved (low demand/low responsibility).

    Measured: 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.

  2. 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:

    • No cumulative total score: The IFIS does not propose a system for summing the scores into a single total score. Instead, each component is analyzed separately, or the overall fitness score is used as a general indicator.
    • Category grouping: In some analyses, the "very poor" and "poor" categories are combined to create a low fitness group due to the low frequency of "very poor" responses.

    Possible Categories:

    • Participants can be categorized into fitness levels based on their responses to each item.
    • Age- and sex-specific z-scores can also be calculate to allow for more accurate group comparisons.

    Measured: 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.

  3. Frequency of food consumption

    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

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Feb 2025
  2. Study start1 Sep 2023
  3. Primary completion30 Jun 2025
  4. Study completion31 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
160 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06828367
Sponsor's protocol ID
ELIKUME 2022
Acronym
ELIKUME
Status last verified
Oct 2026
First submitted
28 Jan 2025
Last updated
16 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: There is no plan to share data, but it is possible to do so at the end of the study anonymously.

Publications

  • Hughes SO, Power TG, Orlet Fisher J, Mueller S, Nicklas TA. Revisiting a neglected construct: parenting styles in a child-feeding context. Appetite. 2005 Feb;44(1):83-92. doi: 10.1016/j.appet.2004.08.007. Epub 2004 Nov 13.

    PubMed 15604035
  • Dhana K, Haines J, Liu G, Zhang C, Wang X, Field AE, Chavarro JE, Sun Q. Association between maternal adherence to healthy lifestyle practices and risk of obesity in offspring: results from two prospective cohort studies of mother-child pairs in the United States. BMJ. 2018 Jul 4;362:k2486. doi: 10.1136/bmj.k2486.

    PubMed 29973352
  • Serra-Majem L, Ribas L, Ngo J, Ortega RM, Garcia A, Perez-Rodrigo C, Aranceta J. Food, youth and the Mediterranean diet in Spain. Development of KIDMED, Mediterranean Diet Quality Index in children and adolescents. Public Health Nutr. 2004 Oct;7(7):931-5. doi: 10.1079/phn2004556.

    PubMed 15482620
  • Serra-Majem L, Ribas L, Ramon JM. Compliance with dietary guidelines in the Spanish population. Results from the Catalan Nutrition Survey. Br J Nutr. 1999 Apr;81 Suppl 2:S105-12. doi: 10.1017/s0007114599001786.

    PubMed 10999034
  • Anderson SE, Whitaker RC. Attachment security and obesity in US preschool-aged children. Arch Pediatr Adolesc Med. 2011 Mar;165(3):235-42. doi: 10.1001/archpediatrics.2010.292.

    PubMed 21383273
  • Hirst JE, Villar J, Papageorghiou AT, Ohuma E, Kennedy SH. Preventing childhood obesity starts during pregnancy. Lancet. 2015 Sep 12;386(9998):1039-40. doi: 10.1016/S0140-6736(15)00142-7. No abstract available.

    PubMed 26382994
  • Aranceta Bartrina J. Public health and the prevention of obesity: failure or success? Nutr Hosp. 2013 Sep;28 Suppl 5:128-37. doi: 10.3305/nh.2013.28.sup5.6928.

    PubMed 24010753
  • Zarnowiecki D, Sinn N, Petkov J, Dollman J. Parental nutrition knowledge and attitudes as predictors of 5-6-year-old children's healthy food knowledge. Public Health Nutr. 2012 Jul;15(7):1284-90. doi: 10.1017/S1368980011003259. Epub 2011 Dec 14.

    PubMed 22166312

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