Impact of a Playful Family Education Strategy With ICT on Childhood Obesity Prevention
NCT Number: NCT06486493
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Pediatric Obesity|Childhood Obesity|Childhood Overweight
Interventions: OTHER: Conventional treatment|OTHER: Playful Family Education Strategy|OTHER: Reinforced Playful Family Education Strategy
Sponsor: Instituto Mexicano del Seguro Social
Collaborators: Doctorado en Ciencias Biomédicas, Universidad Nacional Autónoma de México|Facultad de Medicina, Universidad Nacional Autónoma de México|Escuela Superior de Medicina, Instituto Politécnico Nacional|Instituto Nacional de Salud Pública
Sex: ALL
Age: CHILD
Enrollment: 196
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: PREVENTION
Start Date: 2025-01
Completion Date: 2029-12
Locations: Unidad de Investigación Médica en Bioquímica, Unidad Médica de Alta Especialidad "Dr. Bernardo Sepúlveda", Centro Médico Nacional Siglo XXI, Instituto Mexicano del Seguro Social, Mexico City, Cuauhtémoc, 06720, Mexico

Summary:
The goal of this non-randomized clinical controlled trial is to evaluate the impact of a playful family education strategy reinforced by the use of communication technologies in childhood obesity. The main questions to answer are:

* Does a technogical reinforced ludical family strategy might reduce overweight and childhood obesity prevalence and incidence reduction?
* Can digital reinforcement might decrease body weight, BMI, body fat mass and waist circumference in overweight or obese children?
* Does dietary habits might be improved by a technologically reinforced playful family workshop?

Researchers will compare an obesity childhood digital reinforced group to an overweight control overweight group, an overweight workshop group and a childhood obesity control group to see if technological reinforcement works to reduce and prevent childhood obesity.

Primary Outcome Measures: Reduction of childhood obesity incidence and prevalence, The prevalence of obesity will be assesed by measuring the proportion of children transitioning from obesity to overweight, according to the Centers for Disease Control and Prevention (CDC) criteria for childhood obesity. And the incidence will be determined by the proportion of overweight children who maintain their overweight status over time., Baseline, 3-month and 6-month evaluation from the start of intervention, and subsequently, at 6, 12 and 18 months post-intervention.
Secondary Outcome Measures: Body weight, It will be measured using a Seca scale with an accuracy of 0.1 kg, following standardized international procedures.

According to previous studies, investigators anticipate a 5% body weight baseline reduction, at the end of intervention., Baseline, 3-month and 6-month evaluation from the start of intervention, and subsequently, at 6, 12 and 18 months post-intervention.|Body Mass Index (BMI), It will be assessed using body weight, and height (measured with a stadiometer with an accuracy of 0.1 cm, Weighing and Measuring Station with Frankfort line, SECA model 284), following standardized international procedures.

Using these data, BMI (kg/m²) will be calculated and children will be classified according to their BMI percentile based on WHO and CDC charts.

Researchers expect that children classified as overweight (BMI above the 85th percentile) will achieve a normal weight by the end of the intervention, while those classified as obese (BMI ≥ 97th percentile) will shift to the overweight category. Additionally, a reduction in BMI Z score is anticipated in both interventional and reinforced groups., Baseline, 3-month and 6-month evaluation from the start of intervention, and subsequently, at 6, 12 and 18 months post-intervention.|Fat Mass, It will be assessed by bioimpedance with the TANITA Iron Kids BF 689 body composition analyzer.

After intervention investigators expect a diminishment of body fat mass percentage at the end of intervention., Baseline, 3-month and 6-month evaluation from the start of intervention, and subsequently, at 6, 12 and 18 months post-intervention.|Waist circumference, Measured with a Seca 201 Ergonomic Waist Circumference Measuring Tape, collocated around the stand up children body between the middle point of the anterior superior iliac spine and the costal margin, after breathing out.

They will be classified according to the Third National Health and Nutrition Examination Survey (NHANES III) waist circumference tables for Mexican American children, and a percentile above 90 will be considered as an elevated risk.

Investigators anticipate a reduction of waist circumference at the end of intervention in the interventional and reinforced groups., Baseline, 3-month and 6-month evaluation from the start of intervention, and subsequently, at 6, 12 and 18 months post-intervention.|Dietary habits, It will be assessed by a 24 hour Food Frequency Questionnaire (FFQ) to capture children's usual food and drinks consumption by querying the frequency at which a predefined food list items are consumed, including portion sizes, nutrient intake (calories, fats, proteins, carbohydrates, vitamins and minerals), eating patterns (timing, frequency, and types of meals or snacks), food diversity and diet quality.

Investigators anticipate a reduction of consumed carbohydrates, sweetened beverages, calorie and fat intake at the end of intervention. Accompanied by an improvement of eating patterns, food diversity and diet quality according to dietary guidelines., Baseline, 3-month and 6-month evaluation from the start of intervention, and subsequently, at 6, 12 and 18 months post-intervention.