Clinical trial NCT06828367: EFFECT OF A ONLINE NUTRITION EDUCATION PROGRAM IN PRESCHOOLER'S FAMILIES ON THEIR ADHERENCE TO THE MEDITERRANEAN DIET
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
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Prevention of Childhood Obesity
Community Health Education
Keywords: Pediatric Obesity
Primary Prevention
Mediterranean Diet
Child Day Care Centers
Preschool Children
Mother-Child Relations
Lead sponsor: Fundacion Miguel Servet
Sponsor class: OTHER
Collaborators: name: Universidad Pública de Navarra
name: NavarraBiomed Biomedical Research Center
First posted: 2025-02-14
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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 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.

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

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

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

Primary outcomes:
measure: BMI z-score
timeFrame: Before and through intervention completion, an average of 6 months, and at 3 years of follow-up (5-6 years old).
measure: Adherence to Mediterranean diet
timeFrame: 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:
measure: Caregiver feeding style
timeFrame: 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.
measure: Physical activity
timeFrame: 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.
measure: Frequency of food consumption
timeFrame: 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.
Other outcomes:
measure: Demographic data
timeFrame: Only at enrollment
measure: Anthropometric data
timeFrame: Before and through intervention completion, an average of 6 months, and at 3 years of follow-up (5-6 years old).
measure: Breastfeeding
timeFrame: Only at enrollment
measure: Complementary feeding
timeFrame: Only at enrollment
measure: Mashed food
timeFrame: Before and through intervention completion, an average of 6 months, and at 3 years of follow-up (5-6 years old).
measure: Screen while meats
timeFrame: Before and through intervention completion, an average of 6 months, and at 3 years of follow-up (5-6 years old).
Locations:
city: Pamplona
country: Spain
facility: Asociación Navarra de Pediatría
state: Navarra
Study officials:
affiliation: Universidad Pública de Navarra
name: Maria Medrano, PhD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.