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

NCT07159971 | Recruiting DMC

• 1 other identifier: 3738
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Overweight and/or Obesity; Children - Malnutrition; Preventing Malnutrition

Keywords

Obesity; Children; mHealth; Intervention; Family-base

Outcome Measures

Primary Outcomes (16)

• 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 Outcomes (1)

• Z-Score

  Six months

Study Arms (2)

School B

EXPERIMENTAL

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

School A.

ACTIVE COMPARATOR

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

Interventions

Control OTHER

Conventional nutritional treatment.

School A.

School B DEVICE

Nutritional therapy supported by a mobile application.

School B

Eligibility Criteria

• Age: 5 Years - 9 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Illinois at Urbana-Champaign: collaborator
• Universidad Nacional Autonoma de Mexico: collaborator
• Claudia Teresa Tovar Palacio: lead
• Instituto Nacional de Medicina Genomica: collaborator
• Fundación Gonzalo Río Arronte: collaborator

Study Sites (1)

"El globo" and "Servicios de Salud Lomas Altas"

México, Sonora, Mexico

RECRUITING

MeSH Terms

Conditions

Child Nutrition Disorders; Obesity

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases; Overweight; Overnutrition; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Claudia Tovar-Palacio, Ph.D.

  Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Claudia Tovar-Palacio, Ph.D.

CONTACT

+52 5585341831; claudia.tovarp@incmnsz.mx

Berenice Palacios-Gonzalez, Ph.D.

CONTACT

5553501900; bpalacios@inmegen.gob.mx

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: July 7, 2025
• First Posted: September 8, 2025
• Study Start: June 30, 2025
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 24, 2026

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)