Family-based Intervention Model to Prevent Childhood Obesity Among Schoolage Children in Sonora, Mexico.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Body index mass
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 5 Years to 9 Years (Child)
- Sex
- All
- Accepts 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).
Arms & Interventions
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.
Intervention: School B (Device)
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.
Intervention: Control (Other)
Outcomes
Primary Outcomes
Body index mass
Time Frame: Six months
Measured in Kg/m2
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.
Age
Time Frame: Six months
Years lived reported by parents through medical records
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.
Body weight
Time Frame: Six months
The total body weight (kg) observed in the intervention group versus the control group.
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
Height
Time Frame: Six months
Mean values of anthropometric measurements obtained using a stadiometer, expressed in centimeters.
Fat mass
Time Frame: Six months
Children's fat mass, as determined by bioelectrical impedance analysis, will be expressed as a percentage (%).
Fat-free mass
Time Frame: Six months
Children's fat-free mass, as determined by bioelectrical impedance analysis, will be expressed as a percentage (%).
Glucose
Time Frame: Six months
Change in glucose concentration will be determined by measuring capillary blood glucose levels (mg/dL)
Triacylglycerides
Time Frame: Six months
Changes in triacylglycerol concentration will be determined by measuring capillary blood triacylglycerol levels (mg/dL)
Total cholesterol
Time Frame: Six months
Changes in total cholesterol concentration will be determined by measuring capillary blood cholesterol levels (mg/dL).
HDL-Cholesterol
Time Frame: Six months
Changes in HDL-cholesterol concentration will be determined by measuring capillary blood HDL-cholesterol levels (mg/dL).
LDL-cholesterol
Time Frame: Six months
Changes in LDL-cholesterol concentration will be determined by measuring capillary blood LDL-cholesterol levels.
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.
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
- Z-Score(Six months)
Investigators
Claudia Teresa Tovar Palacio
Dr.
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran