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| Name | Class |
|---|---|
| Universidad Pública de Navarra | OTHER |
| NavarraBiomed Biomedical Research Center | OTHER |
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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.
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:
Recruitment (start of the school year):
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Online family educational intervention and cooking workshop |
|
| Control | No Intervention | Usual care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
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| Measure | Description | Time Frame |
|---|---|---|
| Demographic data | 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). | Only at enrollment |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maria Medrano, PhD | Universidad Pública de Navarra | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asociación Navarra de PediatrÃa | Pamplona | Navarre | 31002 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15604035 | Background | 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. | |
| 29973352 | 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. |
| Label | URL |
|---|---|
| Page of the project | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| not necessary | Study Protocol | View IPD |
There is no plan to share data, but it is possible to do so at the end of the study anonymously.
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the investigators have not access to the arm allocation inform
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| 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 | 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:
| 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 | 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 | 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. |
| Anthropometric data | 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. | Before and through intervention completion, an average of 6 months, and at 3 years of follow-up (5-6 years old). |
| Breastfeeding | Duration of breastfeeding (months). | Only at enrollment |
| Complementary feeding | Age of introduction to complementary feeding (puree, solid food) (months) | Only at enrollment |
| Mashed food | Quantity of mashed food in diet (3 levels: <10%, 10-50%, >50%) | Before and through intervention completion, an average of 6 months, and at 3 years of follow-up (5-6 years old). |
| Screen while meats | 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) | Before and through intervention completion, an average of 6 months, and at 3 years of follow-up (5-6 years old). |
| 15482620 | 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. |
| 10999034 | 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. |
| 21383273 | 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. |
| 26382994 | 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. |
| 24010753 | 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. |
| 22166312 | 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. |
is a public document |
| ID | Term |
|---|---|
| D006266 | Health Education |
| D063766 | Pediatric Obesity |
| ID | Term |
|---|---|
| D000099060 | Adherence Interventions |
| D055118 | Medication Adherence |
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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