Family-Based Nutrition Intervention to Prevent Overweight and Obesity in School-Age Children.
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age5-9
SponsorClaudia Teresa Tovar Palacio
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
School B
DeviceNutritional therapy supported by a mobile application.
Control
Other interventionConventional nutritional treatment.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: School BExperimental treatment 1 intervention
Group B: School A.Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Six months2
Body index mass
Measured in Kg/m2
Time frame
Six months3
Age
Years lived reported by parents through medical records
Time frame
Six months4
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.
Time frame
Six monthsSecondary outcomes
1
Z-Score
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
Time frame
Six monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Claudia Teresa Tovar Palacio
Lead sponsor
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Sponsor institution
Fundación Gonzalo Río Arronte
Collaborator
Instituto Nacional de Medicina Genomica
Collaborator
University of Illinois at Urbana-Champaign
Collaborator
Universidad Nacional Autonoma de Mexico
Collaborator
Source ClinicalTrials.gov