Impact of a Playful Family Education Strategy With ICT on Childhood Obesity Prevention

NCT06486493 | Not Yet Recruiting DMC

• 4 other identifiers: R-2020-785-036059409-CEI-009-2016060117 CI 09 015 006
• Study Type: interventional
• Target: 196
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pediatric Obesity; Childhood Obesity; Childhood Overweight

Keywords

Pediatric Obesity; Childhood Obesity; Educational Activities; Technology

Outcome Measures

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.

  Baseline, 3-month and 6-month evaluation from the start of intervention, and subsequently, at 6, 12 and 18 months post-intervention.

Secondary Outcomes (5)

• Body weight

  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)

  Baseline, 3-month and 6-month evaluation from the start of intervention, and subsequently, at 6, 12 and 18 months post-intervention.

• Fat Mass

  Baseline, 3-month and 6-month evaluation from the start of intervention, and subsequently, at 6, 12 and 18 months post-intervention.

• Waist circumference

  Baseline, 3-month and 6-month evaluation from the start of intervention, and subsequently, at 6, 12 and 18 months post-intervention.

• Dietary habits

  Baseline, 3-month and 6-month evaluation from the start of intervention, and subsequently, at 6, 12 and 18 months post-intervention.

Study Arms (4)

Overweight conventional treatment group

ACTIVE COMPARATOR

Children between 9 to 12 years old, from the Family Medicine Unit No. 1 and 3 (IMSS, Morelos) with a BMI Z-score 1 to 2 standard deviations above the median of the established growth patterns by age and sex, and a BMI above the 85th percentile, according to the World Health Organization (WHO) and the Centers for Disease Control and Prevention (CDC). Who will be treated with conventional 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.

Other: Conventional treatment

Overweight workshop group

EXPERIMENTAL

Children between 9 to 12 years old, from the Family Medicine Unit No. 23 (IMSS, Mexico City) with a BMI Z-score 1 to 2 standard deviations above the median of the established growth patterns by age and sex, and a BMI above the 85th percentile according to WHO and CDC. Treated with a workshop based on national and international guidelines for the management of overweight and obesity, and best practices for the control and reduction of overweight and obesity in school-aged children, by the Food and Agriculture Organization (FAO). The workshop will consist of a monthly session over six months for parents and children, with a follow-up of 18 months post-intervention. In addition to the conventional medical treatment by their physicians, according to the Clinical Practice Guidelines.

Other: Playful Family Education Strategy

Obesity conventional treatment group

ACTIVE COMPARATOR

Children between 9 to 12 years old, from the Family Medicine Unit No. 1 and 3 (IMSS, Morelos) with a BMI Z-score 3 standard deviations above the median of the established growth patterns by age and sex, and a BMI above the 97th percentile according to WHO and CDC. Treated with conventional medical treatment by their physicians, according to 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.

Other: Conventional treatment

Obesity reinforcement group

EXPERIMENTAL

Children between 9 to 12 years old, from the Family Medicine Unit No. 23 (IMSS, Mexico City) with a BMI Z-score 3 standard deviations above the median of the established growth patterns by age and sex, and a BMI above the 97th percentile according to WHO and CDC. Treated with conventional medical treatment by their physicians, according to 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). Furthermore, in addition to the previously mentioned workshop with monthly sessions over six months for parents and children, there will be reinforcement through biweekly technological algorithms. This will be followed by an 18-month post-intervention follow-up.

Other: Reinforced Playful Family Education Strategy

Interventions

Conventional treatment OTHER

Conventional 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.

Obesity conventional treatment group; Overweight conventional treatment group

Playful Family Education Strategy OTHER

Workshop 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.

Overweight workshop group

Reinforced Playful Family Education Strategy OTHER

The 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.

Obesity reinforcement group

Eligibility Criteria

• Age: 9 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.
• Families with access to Wi-Fi connection or mobile internet.
• Children with digital device (Smartphone or Tablet) access, supervised by their parents.

You may not qualify if:

• 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.
• Participants enrolled in another research protocol of any kind.

Sponsors & Collaborators

• Instituto Mexicano del Seguro Social: lead
• 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

Study Sites (1)

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

Location

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• José de Jesús Peralta Romero, PhD

  Instituto Mexicano del Seguro Social

  PRINCIPAL INVESTIGATOR

• María Fernanda Pérez Hernández, MsC

  Instituto Mexicano del Seguro Social

  STUDY DIRECTOR

Central Study Contacts

José de Jesús Peralta Romero, PhD

CONTACT

+52 5532318563; drjjperalta@gmail.com

María Fernanda Pérez Hernández, MsC

CONTACT

+52 5574021093; marferperezh@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator, head of clinical department of the Unidad de Investigación Médica en Bioquímica, Unidad Médica de Alta Especialidad "Dr. Bernardo Sepúlveda", Centro Médico Nacional Siglo XXI, IMSS, Mexico City

Study Record Dates

• First Submitted: June 27, 2024
• First Posted: July 3, 2024
• Study Start: January 1, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2029
• Last Updated: July 3, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)