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

Effect of a Physical Activity and Nutrition Education Intervention on Obesity Prevalence in Schoolchildren From Caaguazu Department, Paraguay: A Clustered Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Childhood Obesity
• Intervention / Treatment: Behavioral: Nutrition education and Physical activity intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 1568
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Paraguay
  • Caaguazu
    • Coronel Oviedo, Caaguazu, Paraguay, 00000
      • Instituto Regional de Investigacion en Salud

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Nutrition education + Physical activity intervention; Physical Activity and Nutrition Education: An additional 45 minute weekly physical education class and 5 weekly active break sessions of 10 minutes each will be added to the provisions of the children's curriculum. In addition, schools will receive high intensity nutrition education, that is, 3 weekly nutrition education classes of one hour in each session over a period of 6 months.	Behavioral: Nutrition education and Physical activity intervention; Schools randomized to the experimental group received nutrition education sessions and physical activity classes.
NO_INTERVENTION: Control; Schools receiving a lower intensity nutrition education served as control. This group received 3 sessions of 1 hour with a total of 3 educational sessions over the 6 month period. The educational material was the same as the intervention group but the development of lessons was not as specific and deep as the intervention group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Skinfold thickness	Continuous variable, measured in millimeters (mm)	6 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Patricia Celestina Ríos Mujica
• Collaborators: PROCIENCIA, Consejo Nacional de Ciencia y Tecnología
• Investigators: Study Director: Patricia Rios, IRIS UNCA

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2018
• Primary Completion (ACTUAL): March 30, 2019
• Study Completion (ACTUAL): March 30, 2019

Study Registration Dates

• First Submitted: May 25, 2021
• First Submitted That Met QC Criteria: May 25, 2021
• First Posted (ACTUAL): May 28, 2021

Study Record Updates

• Last Update Posted (ACTUAL): May 28, 2021
• Last Update Submitted That Met QC Criteria: May 25, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: Childhood Obesity, Nutrition Education, Physical Activity; Intervention, Schools
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Pediatric Obesity
• Other Study ID Numbers: PINV15426

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Protocol
• IPD Sharing Time Frame: all the time
• IPD Sharing Access Criteria: investigators
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No