Clinical trial

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

Recruiting now · Not applicable · 1 countries · Registry ID NCT07159971

Recruiting nowNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age5 Years to 9 Years

SexAll

Healthy volunteersAccepted

ConditionOverweight and/or Obesity, Children - Malnutrition, Preventing Malnutrition

Full registry 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).

Treatments and study arms

School B

Device

Nutritional therapy supported by a mobile application.

Control

Other

Conventional nutritional treatment.

Primary outcomes

Dietary behaviorSix months

The Children's Eating Behavior Questionnaire (CEBQ) will be administered. The responses will be scored and interpreted using standardized scales, yielding two main dimensions: overeating-related behaviors (where higher scores indicate increased risk of obesity) and undereating-related behaviors (where higher scores suggest risk of underweight or feeding difficulties). Each dimension is further divided into four subscales, allowing for a more detailed characterization of eating behavior patterns.

Body index massSix months

Measured in Kg/m2

AgeSix months

Years lived reported by parents through medical records

Feeding practicesSix months

Comprehensive Feeding Practices Questionnaire (CFPQ). The CFPQ evaluates parental feeding behaviors across two primary domains, each comprising six subscales. The first domain encompasses health-promoting feeding practices (e.g., modeling, monitoring), while the second includes negative or problematic feeding practices (e.g., use of food as a reward, restrictive practices). Higher scores in health-promoting practices are positively associated with healthier dietary patterns in children. In contrast, higher scores in negative practices are linked to an increased risk of pediatric obesity and disordered eating behaviors.

Body weightSix months

The total body weight (kg) observed in the intervention group versus the control group.

Phisical activitySix months

This questionnaire assesses children's average physical activity (expressed in MET-minutes per week) and sedentary time (in hours/day) across weekdays

HeightSix months

Mean values of anthropometric measurements obtained using a stadiometer, expressed in centimeters.

Fat massSix months

Children's fat mass, as determined by bioelectrical impedance analysis, will be expressed as a percentage (%).

Study locations

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"El globo" and "Servicios de Salud Lomas Altas"🇲🇽 México, Sonora, Mexico

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Claudia Tovar-Palacio, Ph.D.Contact

Email · Call +52 5585341831

Fernanda Martinez García, M.Sc.Contact

Email · Call +525549398899