Clinical trial NCT04905966: Effect of a Physical Activity and Nutrition Education Intervention on Obesity Prevalence in Schoolchildren
Official title: Effect of a Physical Activity and Nutrition Education Intervention on Obesity Prevalence in Schoolchildren From Caaguazu Department, Paraguay: A Clustered Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Childhood Obesity
Keywords: Childhood Obesity, Nutrition Education, Physical Activity
Intervention, Schools
Lead sponsor: Instituto Regional de Investigación en Salud "Kaneo Shibata" UNCA
Sponsor class: OTHER
Collaborators: name: PROCIENCIA, Consejo Nacional de Ciencia y Tecnología
First posted: 2021-05-28
Enrollment: 1568
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Four groups of participants received four different interventions: (1) Nutrition education + Physical Activity; (2) Control
Primary purpose: PREVENTION

Brief summary: Childhood obesity is a major global public health problem. Several strategies have been implemented to reduce the high prevalence, the most cost-effective of which were those that focused on the school environment. Although there is vast research that focus on interventions that address obesity through interventions to improve schoolchildren diets and physical activity level in many countries of the Latin American region, there is lack of evidence of the effectiveness of multicomponent interventions that aim to reduce the prevalence of obesity among schoolchildren in the Paraguayan context.

Detailed description: Nutritional education and physical activity. Interventions that promote healthy eating and lifelong physical activity in schoolchildren through school programs aim to equip children with knowledge, attitudes and behavioral skills to help them establish and maintain a healthy lifestyle.

Poor diet quality has been identified as one of the main factors contributing to the obesity epidemic. Research has shown that a diet that includes the recommended servings of fruits and vegetables (VF) reduces morbidity and mortality from non-communicable diseases (NCDs) and has also been linked to a lower risk of adiposity. Therefore, the need to promote the consumption of VF from an early age through effective programs.

The interventions in Physical Activity have shown effective results in the decrease of BMI, the thickness of the skin folds and the percentage of fat mass in school-age children. Taking into account that currently the schoolchildren have decreased the amount of time dedicated to games, sports or other types of movement and the hours of sedentary life and in front of the screens (computers, tablets, television, mobile phones, others) have increased.

It is necessary to promote the performance of physical activity in the school environment through permanent programs that contribute to improving the physical condition of children, complying with daily recommendations.

Eligibility criteria: Inclusion Criteria:

* Being public or private schools of the 22 districts of Caaguazú Department
* Having a minimum of 100 students in each of the three grades of second level of basic school education during 2017 school year
* Having physical education teachers

Exclusion Criteria:

* Schools that had only one school shift
* Schools that expressed their refusal to participate

Primary outcomes:
measure: Skinfold thickness
timeFrame: 6 months
Secondary outcomes:
measure: Fruit and vegetables intake
timeFrame: 6 months
measure: Physical activity level
timeFrame: 6 months
measure: Nutritional status
timeFrame: 6 months
measure: Waist circumference
timeFrame: 6 months
Other outcomes:
Locations:
city: Coronel Oviedo
country: Paraguay
facility: Instituto Regional de Investigacion en Salud
state: Caaguazu
Study officials:
affiliation: IRIS UNCA
name: Patricia Rios
role: STUDY_DIRECTOR
References: