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

March 19, 2026 updated by: Claudia Teresa Tovar Palacio

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Mexico
    • Sonora
      • México, Sonora, Mexico
        • Recruiting
        • "El globo" and "Servicios de Salud Lomas Altas"
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Dietary behavior
Time Frame: Six 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.
Six months
Body index mass
Time Frame: Six months
Measured in Kg/m2
Six months
Age
Time Frame: Six months
Years lived reported by parents through medical records
Six months
Feeding practices
Time Frame: Six 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.
Six months
Body weight
Time Frame: Six months
The total body weight (kg) observed in the intervention group versus the control group.
Six months
Phisical activity
Time Frame: Six months
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
Time Frame: Six months
Mean values of anthropometric measurements obtained using a stadiometer, expressed in centimeters.
Six months
Fat mass
Time Frame: Six months
Children's fat mass, as determined by bioelectrical impedance analysis, will be expressed as a percentage (%).
Six months
Fat-free mass
Time Frame: Six months
Children's fat-free mass, as determined by bioelectrical impedance analysis, will be expressed as a percentage (%).
Six months
Glucose
Time Frame: Six months
Change in glucose concentration will be determined by measuring capillary blood glucose levels (mg/dL)
Six months
Triacylglycerides
Time Frame: Six months
Changes in triacylglycerol concentration will be determined by measuring capillary blood triacylglycerol levels (mg/dL)
Six months
Total cholesterol
Time Frame: Six months
Changes in total cholesterol concentration will be determined by measuring capillary blood cholesterol levels (mg/dL).
Six months
HDL-Cholesterol
Time Frame: Six months
Changes in HDL-cholesterol concentration will be determined by measuring capillary blood HDL-cholesterol levels (mg/dL).
Six months
LDL-cholesterol
Time Frame: Six months
Changes in LDL-cholesterol concentration will be determined by measuring capillary blood LDL-cholesterol levels.
Six months
Parenting practices
Time Frame: Six months

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
Time Frame: Six month
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Z-Score
Time Frame: Six months

Change in Z-score scale:

  1. - 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
  2. - 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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Claudia Teresa Tovar Palacio

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Illinois at Urbana-Champaign
Universidad Nacional Autonoma de Mexico
Instituto Nacional de Medicina Genomica
Fundación Gonzalo Río Arronte

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Claudia Tovar-Palacio, Ph.D., Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 30, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 7, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 29, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 8, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 24, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 19, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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