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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-30

Study Completion Date

2026-12-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Overweight and/or Obesity Children - Malnutrition Preventing Malnutrition

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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School B

Nutritional therapy supported by a mobile application. The app integrates a multimodal approach (educational content, interactive tools, and gamification) to promote healthy eating, featuring parent-child dyad-focused resources such as recipe tutorials with family-specific adaptations.

Group Type EXPERIMENTAL

School B

Intervention Type DEVICE

Nutritional therapy supported by a mobile application.

School A.

Nutritional therapy will be delivered through a mobile application that will integrate a multimodal approach, including educational content, interactive tools, and gamification, to promote healthy eating. The application will incorporate parent-child dyad-focused resources, such as recipe tutorials adapted to specific family needs.

Group Type ACTIVE_COMPARATOR

Control

Intervention Type OTHER

Conventional nutritional treatment.

Interventions

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School B

Nutritional therapy supported by a mobile application.

Intervention Type DEVICE

Control

Conventional nutritional treatment.

Intervention Type OTHER

Eligibility Criteria

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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).

Minimum Eligible Age

5 Years

Maximum Eligible Age

9 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes