A New Technological Intervention to Address Childhood Obesity:
NURSPEDIAOBE
1 other identifier
interventional
215
1 country
1
Brief Summary
Childhood obesity is a global public health issue, with rising prevalence rates. In Spain, the problem is significant, particularly in the southern regions. Factors contributing to childhood obesity include dietary habits, lack of physical activity, and socioeconomic influences. Efforts to address childhood obesity in Spain include various programs focusing on dietary modification, increased physical activity, and family involvement. Despite these initiatives, there is a need for continued intervention, as changing dietary and lifestyle patterns have led to reduced fruit and vegetable consumption and increased sedentary behavior among children. Childhood obesity has concerning health implications, including heart-related issues. Echocardiography plays a vital role in early detection. Given the limited research on the impact of childhood obesity on musculoskeletal development and mobility, a comprehensive study is needed to analyze its prevalence and associated factors. The study aims to assess the effectiveness of nutritional interventions administered by school nurses. In summary, childhood obesity in Spain is a growing concern, with multifaceted causes and health implications. Ongoing efforts are required to combat this issue and promote healthier lifestyles among children.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2024
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 17, 2024
CompletedFirst Posted
Study publicly available on registry
May 10, 2024
CompletedStudy Start
First participant enrolled
May 30, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 12, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
June 11, 2024
June 1, 2024
2.5 years
April 17, 2024
June 10, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (12)
Weight (kg)
Weight, as a pivotal anthropometric measure, will be quantified using a validated weight machine, alongside a body composition monitor such as the BF511. The validated weight machine adheres to established calibration standards, ensuring precision and consistency in measurements. It employs advanced technology to accurately assess an individual's weight in kilograms (kg), providing reliable data for scientific analyses.
From 12 weeks (1st measurement) up 15th months (6th measurement)
Height (m2)
Height will be registered in meters squared (m\^2) for its precise evaluation. Employing a validated tachymeter, a specialized instrument designed for accurate measurements, ensures meticulous assessment of height.
From 12 weeks (1st measurement) up 15th months (6th measurement)
Percentage Lean Mass (LM) (%)
The lean fat, calculated in percentage, will be obtained using a validated weight machine, alongside a body composition monitor such as the BF511.
From 12 weeks (1st measurement) up 15th months (6th measurement)
Percentage Fat Mass (FM) (%)
The lean fat, calculated in percentage, will be obtained using a validated weight machine, alongside a body composition monitor such as the BF511.
1st month, 3 month, 6 month, 9 month, 12th and 15th month
Body Mass Index (kg/m2)
The Body Mass Index will be calculated using the percentiles according to age group and sex.
From 12 weeks (1st measurement) up 15th months (6th measurement)
Waist circumference (cm)
The waist circumference (cm) of the children will be measured via an inextensible measuring tape at the initial visit (1st month or V0) and at the last visit (15th month or V6).The measurement follows the recommendations of the International Standards for Anthropometric Assessment
From 12 weeks (1st measurement) up 15th months (6th measurement)
Hip circumference(cm)
The Hip circumference(cm) of the children will be measured via an inextensible measuring tape at the initial visit (1st month or V0) and at the last visit (15th month or V6).The measurement follows the recommendations of the International Standards for Anthropometric Assessment
From 12 weeks (1st measurement) up 15th months (6th measurement)
Arm circumference (cm)
The arm circumference (cm) of the children will be measured via an inextensible measuring tape at the initial visit (1st month or V0) and at the last visit (15th month or V6).The measurement follows the recommendations of the International Standards for Anthropometric Assessment
From 12 weeks (1st measurement) up 15th months (6th measurement)
Calf circumference (cm)
The arm circumference (cm) of the children will be measured via an inextensible measuring tape at the initial visit (1st month or V0) and at the last visit (15th month or V6).The measurement follows the recommendations of the International Standards for Anthropometric Assessment
From 12 weeks (1st measurement) up 15th months (6th measurement)
Validated nutritional assessment questionnaire: adherence to the Mediterranean diet (KIDMED)
he KIDMED will be used to determine adherence to the change in diet from the initial visit (V0) and the final visit (V6). This questionnaire is formed by 16 questions related to adherence to the Mediterranean diet, in addition to 7 items complementary to the test. All questions were answered positively or negatively. Of the 16 main questions, questions number 6, 11, 14, and 16, in their affirmative answers had a negative meaning, so they were worth (-1), on the other hand, the remaining questions whose affirmative answers represented a positive value concerning the Mediterranean diet were scored with (+1). Negative responses do not score (0). According to the test, the results are grouped into different levels of adherence to the Mediterranean diet, low (score 0 to 3), medium (score 4-7), and high (8 to 12).
From 12 weeks (1st measurement) up 15th months (6th measurement)
Food Consumption Frequency
Food Frequency Questionnaire (FFQ) will be used to determine the consumption of food and the change in diet from the initial visit (V0) and the final visit (V6). Energy and nutrient intakes were calculated using Spanish food composition tables Food consumption frequency refers to the rate at which individuals consume different types of food within a specific time frame, typically measured over a day, week, or month. This variable captures the frequency with which individuals consume various food groups, such as fruits, vegetables, grains, proteins, and processed foods. It provides insight into dietary patterns and habits, indicating how often individuals incorporate different foods into their regular eating routines.
From 12 weeks (1st measurement) up 15th months (6th measurement)
Blood pressure
The systolic and diastolic blood pressure will be taken using an Omron-validated tensiometer with two measurements between 15 minutes each measurement from the 1st visit (v0) to the last (v6).
From 12 weeks (1st measurement) up 15th months (6th measurement)
Secondary Outcomes (1)
3D avatar system for anthropometric measures
From 12 weeks (1st measurement) up 15th months (6th measurement)
Study Arms (2)
Technological intervention
EXPERIMENTALThe experimental arm integrates technology-based interventions-podcasts, gamification, and virtual reality-to promote nutritional education and healthy behaviors. Tailored podcasts cover topics like healthy eating habits and balanced nutrition, while gamification enhances motivation. Virtual reality offers immersive environments for exploring healthy choices. Both experimental and control groups enable a comprehensive evaluation, collecting data through measurements, biometrics, and activity records.
No-technological intervention: traditional brochure
NO INTERVENTIONThe control arm will focus on a non-technological intervention, specifically utilizing traditional brochures. Participants in this arm will receive printed materials containing information on basic nutritional guidelines, healthy eating habits, and the importance of balanced nutrition. The brochure-based intervention aims to provide essential information in a straightforward format, emphasizing key messages related to healthy eating practices. Participants will have access to pamphlets outlining dietary recommendations, portion control, and tips for making nutritious food choices.
Interventions
The intervention comprises workshops, individualized counseling, cooking classes, and physical activity promotion. It emphasizes nutritional education, hands-on cooking, and behavioral modification techniques. Participants receive personalized guidance and resources to make sustainable dietary and lifestyle changes. Social support networks foster motivation and accountability. By combining these components, the intervention aims to empower participants with the knowledge, skills, and support needed for long-term health improvements.
Eligibility Criteria
You may qualify if:
- Students from the school
- Pediatric from age 6 to 16
- Students from the school that confirmed approval
- Signed informed consent by the minor
- Signed informed consent by the minor's parents or guardians.
You may not qualify if:
- Presence of HbA1c levels below 5.7%
- Presence of HbA1c levels above 6.4%
- Presence of pathological metabolic diseases, such as diabetes or metabolic syndrome
- Presence of other diseases related to intestinal integrity or skin issues.
- Lack of the signed informed consent by the minor and legal guardian
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Colegio Virgen del Carmen
Córdoba, 14011, Spain
Related Publications (1)
Blancas-Sanchez IM, Del Rosal Jurado M, Aparicio-Martinez P, Quintana Navarro G, Vaquero-Abellan M, Castro Jimenez RA, Fonseca Pozo FJ. A Mediterranean-Diet-Based Nutritional Intervention for Children with Prediabetes in a Rural Town: A Pilot Randomized Controlled Trial. Nutrients. 2022 Sep 1;14(17):3614. doi: 10.3390/nu14173614.
PMID: 36079871RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Manuel Vaquero Abellan, MD, Msc, PhD
Universidad de Córdoba
- PRINCIPAL INVESTIGATOR
Manuel Vaquero Alvárez, MD, Msc, PhD
Maimónides Biomedical Research Institute of Córdoba
- PRINCIPAL INVESTIGATOR
Isabel Blancas Sanchez, MD, Msc, PhD
Primary Care, Jaen
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Masking Details
- The randomisation will be conducted based on an artificial model, utilising a coding system that assigns numerical identifiers to names, postal codes, and grade levels. This approach ensures a systematic and unbiased selection process, allowing for a fair representation of participants across various demographic factors. The sampling has been estimaited by Epidat program. The experimental group, receiving nutritional intervention, will consist of approximately 50% of the total sample, equivalent to 215 participants. Meanwhile, the control group, not receiving the intervention, will comprise the remaining 50% of the sample, also around 215 participants. This distribution will enable an effective comparison of results between the two groups and assess the effectiveness of the nutritional intervention.
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
April 17, 2024
First Posted
May 10, 2024
Study Start
May 30, 2024
Primary Completion (Estimated)
December 12, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
June 11, 2024
Record last verified: 2024-06
Data Sharing
- IPD Sharing
- Will not share
The data of the participants will be made available to other researchers under consideration and analysis of the research committee.