Clinical trial NCT06486493: Impact of a Playful Family Education Strategy With ICT on Childhood Obesity Prevention
Official title: Effectiveness of a Family Playful / Ludic Educational Strategy Reinforced With the Use of Information and Communication Technologies in the Prevention and Reduction of Childhood Obesity
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pediatric Obesity
Childhood Obesity
Childhood Overweight
Keywords: Pediatric Obesity
Childhood Obesity
Educational Activities
Technology
Lead sponsor: Instituto Mexicano del Seguro Social
Sponsor class: OTHER_GOV
Collaborators: name: Doctorado en Ciencias Biomédicas, Universidad Nacional Autónoma de México
name: Facultad de Medicina, Universidad Nacional Autónoma de México
name: Escuela Superior de Medicina, Instituto Politécnico Nacional
name: Instituto Nacional de Salud Pública
First posted: 2024-07-03
Enrollment: 196
Sex: ALL
Minimum age (years): 9
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed description: One of the main worldwide health problems is adult and childhood obesity, due to the complications arising from this. As World Obesity Federation (WOF) reported that in 2020, a total of 1.39 billion of adults were overweight and 0.81 billions were obese; while 260 million of children were overweight and 175 millions had obesity. Additionally, in 2022 according to the Encuesta Nacional de Salud y Nutrición (ENSANUT) 2020-2022, an 19.2% of childhood overweight prevalence was reported, and 18.1% of childhood obesity, which places our country as the second place in childhood obesity worldwide, only preceded by the USA.

Although it is well-known that the main etiological factor are the poor eating habits, promoted by the excessive consumption of sweetened beverages and ultra-processed foods. Additionally to the nutritional educational programs and guidelines, some strategies have been proposed in Mexico, in an attempt to reduce its consumption, such as the tax to soft drinks and junk food, and the front labeling of foods.

However, previous studies have demonstrated that a family program with the participation of children and parents is required, but not only by the implementation of integrative workshops, but through the reinforcement and support with the use of current technologies that have confirmed an improvement in learning processes.

So, in a pursuit of lowering childhood obesity and overweight prevalence and incidence, researchers created a non-randomized multicentric clinical trial to assess the efficacy of a technologically reinforced playful family educational workshop, on the treatment and prevention of this public health problem.

For this, a total of 196 participants will be allocated into four interventional groups:

1. Overweight children control group ( n = 49 children ) : BMI above the 85th percentile, under conventional medical treatment over six months and a 18 months post-interventional follow-up.
2. Overweight children workshop group ( n = 49 children ) : BMI above the 85th percentile, under conventional medical treatment plus a playful ludical family educational workshop, over six months and a 18 months post-interventional follow-up.
3. Childhood obesity control group ( n = 49 children) : BMI above the 97th percentile, under conventional medical treatment over six months and a 18 months post-interventional follow-up.
4. Childhood obesity digitally reinforcement group ( n = 49 children ) : BMI above the 97th percentile, under conventional medical treatment, plus a playful ludical family educational workshop and technological reinforcement, over six months and a 18 months post-interventional follow-up.

The main objective is that the overweight children workshop group achieve a normal weight or maintain in an overweight status, and those with childhood obesity and digital reinforcement become overweight or reduce body weight, fat mass and waist circumference, as secondary objectives.

Nevertheless, researchers expect the improvement of dietary habits assessed by the 24-hour Food Frequency Questionnaire (FFQ) in both interventional groups, that is the overweight workshop group and the childhood obesity digitally reinforced group.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Reduction of childhood obesity incidence and prevalence
timeFrame: Baseline, 3-month and 6-month evaluation from the start of intervention, and subsequently, at 6, 12 and 18 months post-intervention.
Secondary outcomes:
measure: Body weight
timeFrame: Baseline, 3-month and 6-month evaluation from the start of intervention, and subsequently, at 6, 12 and 18 months post-intervention.
measure: Body Mass Index (BMI)
timeFrame: Baseline, 3-month and 6-month evaluation from the start of intervention, and subsequently, at 6, 12 and 18 months post-intervention.
measure: Fat Mass
timeFrame: Baseline, 3-month and 6-month evaluation from the start of intervention, and subsequently, at 6, 12 and 18 months post-intervention.
measure: Waist circumference
timeFrame: Baseline, 3-month and 6-month evaluation from the start of intervention, and subsequently, at 6, 12 and 18 months post-intervention.
measure: Dietary habits
timeFrame: Baseline, 3-month and 6-month evaluation from the start of intervention, and subsequently, at 6, 12 and 18 months post-intervention.
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Unidad de Investigación Médica en Bioquímica, Unidad Médica de Alta Especialidad "Dr. Bernardo Sepúlveda", Centro Médico Nacional Siglo XXI, Instituto Mexicano del Seguro Social
state: Cuauhtémoc
Study officials:
affiliation: Instituto Mexicano del Seguro Social
name: José de Jesús Peralta Romero, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Instituto Mexicano del Seguro Social
name: María Fernanda Pérez Hernández, MsC
role: STUDY_DIRECTOR
References: