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
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- BMI z-score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
盲法说明
the investigators have not access to the arm allocation inform
入排标准
- 年龄范围
- 18 Months 至 36 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •Families unable to understand the study or who do not speak the language well
- •Refusal to participate
研究组 & 干预措施
Intervention
Online family educational intervention and cooking workshop
干预措施: Online family educational intervention and cooking workshop (Behavioral)
Control
Usual care
结局指标
主要结局
BMI z-score
时间窗: 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).
Adherence to Mediterranean diet
时间窗: 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.
次要结局
- 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.)
- 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.)
- 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.)