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Recruiting NCT07159971

Family-Based Nutrition Intervention to Prevent Overweight and Obesity in School-Age Children.

No phase Interventional Overweight and/or Obesity Children - Malnutrition Preventing Malnutrition

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: School B, Control.
Who it may be relevant to
Registry conditions: Overweight and/or Obesity, Children - Malnutrition, Preventing Malnutrition. Basic parameters: 5 years — 9 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Mexico
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Family-based Intervention Model to Prevent Childhood Obesity Among Schoolage Children in Sonora, Mexico.

Overview

This proposal aims to enhance the well being of schoolchildren and their families through a mobile application and multidisciplinary intervention model grounded in authoritative parenting principles and social cognitive theory.

Detailed description

Childhood is recognized as a critical period of metabolic sensitivity, during which excess adiposity increases the likelihood of developing metabolic abnormalities in adulthood by approximately 70%, including hypertension, dyslipidemia, insulin resistance, hyperuricemia, and non-alcoholic fatty liver disease. In Mexico, overweight and obesity affect 35.5% of school-aged children, inevitably contributing to the growing prevalence of non-communicable chronic diseases. Data from ENSANUT 2018 place Sonora among the five states with the highest rates of obesity, with 22.2% of adolescents aged 12-19 years classified as obese. This epidemiological context highlights the pressing need for innovative strategies to promote prevention and early risk detection during childhood.

Evidence indicates that mobile health (mHealth) applications may effectively reduce body weight and prevent fat accumulation. Nevertheless, only a limited number of studies have applied mHealth interventions to prevent pediatric adiposity or to foster behavioral changes in comparison with conventional nutritional approaches. The proposed model incorporates a communication strategy designed to monitor participant needs, offer engagement incentives, and promote adherence to the study protocol.

The primary research question addresses whether a family-focused intervention can effectively improve eating patterns and food-related behaviors among students enrolled at "La Caridad" Educational Center in Nacozari de García, Sonora.

Interventions

  • Device School B
    Nutritional therapy supported by a mobile application.
  • Other Control
    Conventional nutritional treatment.

Primary outcome measures

  • Dietary behavior [Time frame: Six months]
  • Body index mass [Time frame: Six months]
  • Age [Time frame: Six months]
  • Feeding practices [Time frame: Six months]
  • Body weight [Time frame: Six months]
  • Phisical activity [Time frame: Six months]
  • Height [Time frame: Six months]
  • Fat mass [Time frame: Six months]
  • Fat-free mass [Time frame: Six months]
  • Glucose [Time frame: Six months]
Secondary outcome measures (1)
  • Z-Score [Time frame: Six months]

Eligibility criteria

Inclusion criteria

  • Families of children between 5 and 9 years old.
  • Children without any medical or nutritional treatment for obesity.
  • Children classified as normal weight, overweight, or obese based on WHO (Z-score: height for age and BMI for age).
  • Offspring of mothers aged between 18 and 45 years at delivery.
  • Term infants from normoevolutive pregnancies without maternal comorbidities.
  • Families who have a cell phone with internet access and an installed camera.

Exclusion criteria

  • Children who are currently suffering from a pathology that requires medication or special treatment
  • Mothers/Fathers/Guardians who are currently suffering from a pathology that requires medication or special treatment.
  • Children who have a physical/mental impairment to perform physical activities.
  • Children from surrogate mothers who have presented at least 2 of the 11 DSM-5 criteria for substance use disorder (alcohol, tobacco, cannabis, or other illegal drugs) before or during the participating child's gestation.
  • Children from multiple pregnancies.
  • Parents who do not own a smartphone compatible with the app will be excluded from this study (i.e., version 5.0 or higher for Android).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Prevention

Study locations

Mexico · 1 center
  • "El globo" and "Servicios de Salud Lomas Altas" — México

Identifiers

NCT: NCT07159971 · 3738

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗