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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 196
- 试验地点
- 2
- 主要终点
- Reduction of childhood obesity incidence and prevalence
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 9 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Reduction of childhood obesity incidence and prevalence
时间窗: Baseline, 3-month and 6-month evaluation from the start of intervention, and subsequently, at 6, 12 and 18 months post-intervention.
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.
次要结局
- 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.)
研究者
José de Jesús Peralta Romero
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
Instituto Mexicano del Seguro Social