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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Overweight and/or Obesity; Children - Malnutrition; Preventing Malnutrition
• Intervention / Treatment: Device: School B; Other: Control

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.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Claudia Tovar-Palacio, Ph.D.; Phone Number: +52 5585341831; Email: claudia.tovarp@incmnsz.mx
• Study Contact Backup: Name: Berenice Palacios-Gonzalez, Ph.D.; Phone Number: 1220 5553501900; Email: bpalacios@inmegen.gob.mx

Study Locations

• Mexico
  • Sonora
    • México, Sonora, Mexico
      • Recruiting
      • "El globo" and "Servicios de Salud Lomas Altas"
      • Contact: Claudia Tovar-Palacio, Ph.D.; Phone Number: +52 5585341831; Email: claudia.tovarp@incmnsz.mx
      • Contact: Fernanda Martinez García, M.Sc.; Phone Number: +525549398899; Email: maria.martinezg@incmnsz.mx

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: School B; Nutritional therapy supported by a mobile application.
Active Comparator: 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.	Other: Control; Conventional nutritional treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dietary behavior	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.	Six months
Body index mass	Measured in Kg/m2	Six months
Age	Years lived reported by parents through medical records	Six months
Feeding practices	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.	Six months
Body weight	The total body weight (kg) observed in the intervention group versus the control group.	Six months
Phisical activity	This questionnaire assesses children's average physical activity (expressed in MET-minutes per week) and sedentary time (in hours/day) across weekdays	Six months
Height	Mean values of anthropometric measurements obtained using a stadiometer, expressed in centimeters.	Six months
Fat mass	Children's fat mass, as determined by bioelectrical impedance analysis, will be expressed as a percentage (%).	Six months
Fat-free mass	Children's fat-free mass, as determined by bioelectrical impedance analysis, will be expressed as a percentage (%).	Six months
Glucose	Change in glucose concentration will be determined by measuring capillary blood glucose levels (mg/dL)	Six months
Triacylglycerides	Changes in triacylglycerol concentration will be determined by measuring capillary blood triacylglycerol levels (mg/dL)	Six months
Total cholesterol	Changes in total cholesterol concentration will be determined by measuring capillary blood cholesterol levels (mg/dL).	Six months
HDL-Cholesterol	Changes in HDL-cholesterol concentration will be determined by measuring capillary blood HDL-cholesterol levels (mg/dL).	Six months
LDL-cholesterol	Changes in LDL-cholesterol concentration will be determined by measuring capillary blood LDL-cholesterol levels.	Six months
Parenting practices	The Short Parenting Practices Questionnaire is designed to identify and classify parenting styles based on two primary dimensions: warmth (affection) and control (discipline). In its abbreviated version, the questionnaire asks parents/caregivers to report on items that explore: Authoritative practices: characterized by high warmth and high control, reflected in behaviors such as providing explanations, setting clear rules, showing affection, and promoting autonomy within appropriate limits. Authoritarian practices: characterized by low warmth and high control, reflected in behaviors such as rigid discipline, imposing rules without dialogue, and lower expression of affection. In general, the questionnaire requires self-reported responses regarding the frequency with which parents engage in specific behaviors or strategies in everyday life. These responses are then grouped into the two empirically validated categories.	Six months
Dietary patterns	Using data collected from a food frequency questionnaire (FFQ) and a 24-hour dietary recall will be evaluated for dietary patterns	Six month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Z-Score	Change in Z-score scale: - BMI for age: ≤-3SD is equivalent to severe thinness, ≤-2 is equivalent to thinness, ≥+2 is equivalent to obesity and ≥+1 is equivalent to overweight; - Height for age: ≥ -1 is equivalent to normal, ≥-2 to ≤ -1 is equivalent to moderately stunted and ≤ -2 is equivalent to severely stunted	Six months

Collaborators and Investigators

• Sponsor: Claudia Teresa Tovar Palacio
• Collaborators: University of Illinois at Urbana-Champaign; Universidad Nacional Autonoma de Mexico; Instituto Nacional de Medicina Genomica; Fundación Gonzalo Río Arronte
• Investigators: Principal Investigator: Claudia Tovar-Palacio, Ph.D., Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2025
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: July 7, 2025
• First Submitted That Met QC Criteria: August 29, 2025
• First Posted (Actual): September 8, 2025

Study Record Updates

• Last Update Posted (Actual): March 24, 2026
• Last Update Submitted That Met QC Criteria: March 19, 2026
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Obesity; Children; mHealth; Intervention; Family-base
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Obesity; Child Nutrition Disorders
• Other Study ID Numbers: 3738

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No