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NCT Number: NCT07159971

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

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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Key information

Age range

5 year–9 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

School B

Device

Nutritional therapy supported by a mobile application.

Control

Other

Conventional nutritional treatment.

Primary outcomes

  1. 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.

  2. Body index mass

    Time frame: Six months

    Measured in Kg/m2

  3. Age

    Time frame: Six months

    Years lived reported by parents through medical records

  4. 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.

  5. Body weight

    Time frame: Six months

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

  6. 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

  7. Height

    Time frame: Six months

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

  8. Fat mass

    Time frame: Six months

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

  9. Fat-free mass

    Time frame: Six months

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

  10. Glucose

    Time frame: Six months

    Change in glucose concentration will be determined by measuring capillary blood glucose levels (mg/dL)

  11. Triacylglycerides

    Time frame: Six months

    Changes in triacylglycerol concentration will be determined by measuring capillary blood triacylglycerol levels (mg/dL)

  12. Total cholesterol

    Time frame: Six months

    Changes in total cholesterol concentration will be determined by measuring capillary blood cholesterol levels (mg/dL).

  13. HDL-Cholesterol

    Time frame: Six months

    Changes in HDL-cholesterol concentration will be determined by measuring capillary blood HDL-cholesterol levels (mg/dL).

  14. LDL-cholesterol

    Time frame: Six months

    Changes in LDL-cholesterol concentration will be determined by measuring capillary blood LDL-cholesterol levels.

  15. 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.

  16. 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

Secondary outcomes

  1. Z-Score

    Time frame: Six months

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Berenice Palacios-Gonzalez, Ph.D.

CONTACT

[email protected]

5553501900 ext. 1220

Claudia Tovar-Palacio, Ph.D.

CONTACT

[email protected]

+52 5585341831

Sponsors and collaborators

Lead sponsor

Claudia Teresa Tovar Palacio

Other

Collaborators

  • Fundación Gonzalo Río Arronte
  • Instituto Nacional de Medicina Genomica
  • Universidad Nacional Autonoma de Mexico
  • University of Illinois at Urbana-Champaign

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Sep 8, 2025
Registry last updated
Mar 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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