Effect of a Physical Activity and Nutrition Education Intervention on Obesity Prevalence in Schoolchildren

Childhood Obesity Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04905966
• Other study ID #: PINV15426
• Status: Completed
• Phase: N/A
• Start date: June 1, 2018
• Est. completion date: March 30, 2019

Study information

• Verified date: May 2021
• Source: Instituto Regional de Investigación en Salud "Kaneo Shibata" UNCA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1568
• Est. completion date: March 30, 2019
• Est. primary completion date: March 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Childhood Obesity
• Obesity
• Pediatric Obesity

Intervention

Behavioral:
• Nutrition education and Physical activity intervention
Schools randomized to the experimental group received nutrition education sessions and physical activity classes.

Locations

Country	Name	City	State
Paraguay	Instituto Regional de Investigacion en Salud	Coronel Oviedo	Caaguazu

Sponsors (2)

Lead Sponsor	Collaborator
Patricia Celestina Ríos Mujica	PROCIENCIA, Consejo Nacional de Ciencia y Tecnología

Country where clinical trial is conducted

Paraguay, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Skinfold thickness	Continuous variable, measured in millimeters (mm)	6 months
Secondary	Fruit and vegetables intake	Continuous variable, measured in servings per day	6 months
Secondary	Physical activity level	Categorical variable, measured using MET in minutes/week and classified as low, medium and high intensity	6 months
Secondary	Nutritional status	Categorical variable, measured using BMI/age an classified as undernourished, normal, overweight and obese according to WHO standards	6 months
Secondary	Waist circumference	Continuous variable, measured in centimeters (cm)	6 months