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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.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07159971
Enrollment
40
Registered
2025-09-08
Start date
2025-06-30
Completion date
2027-12-01
Last updated
2026-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Obesity, Children, mHealth, Intervention, Family-base

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.

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.

Interventions

DEVICESchool B

Nutritional therapy supported by a mobile application.

OTHERControl

Conventional nutritional treatment.

Sponsors

Claudia Teresa Tovar Palacio
Lead SponsorOTHER
Fundación Gonzalo Río Arronte
CollaboratorUNKNOWN
Instituto Nacional de Medicina Genomica
CollaboratorOTHER_GOV
University of Illinois at Urbana-Champaign
CollaboratorOTHER
Universidad Nacional Autonoma de Mexico
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
5 Years to 9 Years
Healthy volunteers
Yes

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).

Design outcomes

Primary

MeasureTime frameDescription
Dietary behaviorSix monthsThe 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 monthsMeasured in Kg/m2
AgeSix monthsYears lived reported by parents through medical records
Feeding practicesSix monthsComprehensive 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 monthsThe total body weight (kg) observed in the intervention group versus the control group.
Phisical activitySix monthsThis questionnaire assesses children's average physical activity (expressed in MET-minutes per week) and sedentary time (in hours/day) across weekdays
HeightSix monthsMean values of anthropometric measurements obtained using a stadiometer, expressed in centimeters.
Fat massSix monthsChildren's fat mass, as determined by bioelectrical impedance analysis, will be expressed as a percentage (%).
Fat-free massSix monthsChildren's fat-free mass, as determined by bioelectrical impedance analysis, will be expressed as a percentage (%).
GlucoseSix monthsChange in glucose concentration will be determined by measuring capillary blood glucose levels (mg/dL)
TriacylglyceridesSix monthsChanges in triacylglycerol concentration will be determined by measuring capillary blood triacylglycerol levels (mg/dL)
Total cholesterolSix monthsChanges in total cholesterol concentration will be determined by measuring capillary blood cholesterol levels (mg/dL).
HDL-CholesterolSix monthsChanges in HDL-cholesterol concentration will be determined by measuring capillary blood HDL-cholesterol levels (mg/dL).
LDL-cholesterolSix monthsChanges in LDL-cholesterol concentration will be determined by measuring capillary blood LDL-cholesterol levels.
Parenting practicesSix monthsThe 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.
Dietary patternsSix monthUsing data collected from a food frequency questionnaire (FFQ) and a 24-hour dietary recall will be evaluated for dietary patterns

Secondary

MeasureTime frameDescription
Z-ScoreSix monthsChange 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

Countries

Mexico

Contacts

CONTACTClaudia Tovar-Palacio, Ph.D.
claudia.tovarp@incmnsz.mx+52 5585341831
CONTACTBerenice Palacios-Gonzalez, Ph.D.
bpalacios@inmegen.gob.mx5553501900
PRINCIPAL_INVESTIGATORClaudia Tovar-Palacio, Ph.D.

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 25, 2026