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

NCT06828367 | Enrolling By Invitation

• 1 other identifier: ELIKUME 2022
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Prevention of Childhood Obesity; Community Health Education

Keywords

Pediatric Obesity; Primary Prevention; Mediterranean Diet; Child Day Care Centers; Preschool Children; Mother-Child Relations

Outcome Measures

Primary Outcomes (2)

• 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).

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

• 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.

  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)

• Caregiver feeding style

  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.

• Physical activity

  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.

• Frequency of food consumption

  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 (6)

• Demographic data

  Only at enrollment

• Anthropometric data

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

• Breastfeeding

  Only at enrollment

Study Arms (2)

Intervention

EXPERIMENTAL

Online family educational intervention and cooking workshop

Behavioral: Online family educational intervention and cooking workshop

Control

NO INTERVENTION

Usual care

Interventions

Online family educational intervention and cooking workshop BEHAVIORAL

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.

Intervention

Eligibility Criteria

• Age: 18 Months - 36 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Fundacion Miguel Servet: lead
• Universidad Pública de Navarra: collaborator
• NavarraBiomed Biomedical Research Center: collaborator

Study Sites (1)

Asociación Navarra de Pediatría

Pamplona, Navarre, 31002, Spain

Location

Related Publications (8)

• 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.

  PMID: 15604035 BACKGROUND

• 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.

  PMID: 29973352 BACKGROUND

• 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.

  PMID: 15482620 BACKGROUND

• 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.

  PMID: 10999034 BACKGROUND

• 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.

  PMID: 21383273 BACKGROUND

• 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.

  PMID: 26382994 BACKGROUND

• 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.

  PMID: 24010753 BACKGROUND

• 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.

  PMID: 22166312 BACKGROUND

Related Links

• Page of the project

MeSH Terms

Conditions

Health Education; Pediatric Obesity

Condition Hierarchy (Ancestors)

Adherence Interventions; Medication Adherence; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior; Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Maria Medrano, PhD

  Universidad Pública de Navarra

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: the investigators have not access to the arm allocation inform
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2025
• First Posted: February 14, 2025
• Study Start: September 1, 2023
• Primary Completion: June 30, 2025
• Study Completion (Estimated): December 31, 2028
• Last Updated: February 14, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)