Impact of a Playful Family Education Strategy With ICT on Childhood Obesity Prevention
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age9-12
SponsorInstituto Mexicano del Seguro Social
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
School-age children aged 9 to 12 years from the Family Medicine Unit Number 23 (IMSS, Mexico City) and the Family Medicine Units Number 1 and 3 (IMSS, Morelos).
Children accompanied by their parents who consent to participate in the study.
Children with a BMI equal to or greater than the 85th percentile (indicating overweight or obesity) according to CDC classification.
Children who have agreed to participate through informed consent and assent forms.
Disqualifiers
Children undergoing in any type of weight reduction program, whether pharmacological or non-pharmacological treatment .
Children with a prior diagnosis of endocrinological or congenital diseases, associated with obesity, such as hypothyroidism, Prader-Willi syndrome, growth hormone deficiency, Cushing's syndrome, trisomy 21, among others.
Children with abnormal thyroid function test results.
Children with physical limitations, such as congenital malformations, that may prevent them from engaging in moderate to intense physical activity included in the intervention.
Trial design
Design model
Parallel
Treatments tested in this trial
Conventional treatment
Other interventionConventional medical treatment by their physicians, following the Clinical Practice Guideline for the Prevention and Diagnosis of Overweight and Obesity in Children and Adolescents (SS-025-08) and the Guideline for the Diagnosis, Treatment, and Prevention of Overweight and Obesity in Adults (IMSS 46-08), over six months, with a follow-up of 18 months post-intervention.
Playful Family Education Strategy
Other interventionWorkshop based on national and international guidelines for managing overweight and obesity in school-aged children, by the Food and Agriculture Organization (FAO). Monthly sessions over six months for parents and children, followed by an 18-month post-intervention follow-up. For parents: * First session focuses on raising awareness about childhood obesity through counseling and nutritional advice, promoting water consumption over sugary drinks. * Subsequent sessions use 'case study' technique to discuss common food and nutrition challenges. For children: * Sessions follow the 'Nutritional Guidance Intervention Guide' by the National System for Integral Family Development (DIF). * First session encourages healthy eating habits through activities and educational games. * Later sessions emphasize healthy eating patterns and physical activity.
Reinforced Playful Family Education Strategy
Other interventionThe previosuly created and INDAUTOR registered workshop, will be reinforced through two-week technological algorithms, such as videogames, educational videos, and digital challenges, for the children, that they must complete through their smartphone of tablet. Followed by an 18-month post-intervention follow-up.
Treatment groups
196 Participants
are divided into 4 treatment groupsGroup A: Overweight conventional treatment groupActive comparator 1 intervention
Group B: Overweight workshop groupExperimental treatment 1 intervention
Group C: Obesity conventional treatment groupActive comparator 1 intervention
Group D: Obesity reinforcement groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline, 3-month and 6-month evaluation from the start of intervention, and subsequently, at 6, 12 and 18 months post-intervention.Secondary outcomes
1
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.
Time frame
Baseline, 3-month and 6-month evaluation from the start of intervention, and subsequently, at 6, 12 and 18 months post-intervention.2
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.
Time frame
Baseline, 3-month and 6-month evaluation from the start of intervention, and subsequently, at 6, 12 and 18 months post-intervention.3
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.
Time frame
Baseline, 3-month and 6-month evaluation from the start of intervention, and subsequently, at 6, 12 and 18 months post-intervention.4
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.
Time frame
Baseline, 3-month and 6-month evaluation from the start of intervention, and subsequently, at 6, 12 and 18 months post-intervention.Sponsors and contacts
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Instituto Mexicano del Seguro Social
Lead sponsor
Doctorado en Ciencias Biomédicas, Universidad Nacional Autónoma de México
Collaborator
Facultad de Medicina, Universidad Nacional Autónoma de México
Collaborator
Escuela Superior de Medicina, Instituto Politécnico Nacional
Collaborator
Instituto Nacional de Salud Pública
Collaborator
Source ClinicalTrials.gov
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