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

Primary Purpose

Childhood Obesity

Status
Completed
Phase
Not Applicable
Locations
Paraguay
Study Type
Interventional
Intervention
Nutrition education and Physical activity intervention
Sponsored by
Patricia Celestina Ríos Mujica
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Childhood Obesity focused on measuring Childhood Obesity, Nutrition Education, Physical Activity, Intervention, Schools

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Instituto Regional de Investigacion en Salud

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Nutrition education + Physical activity intervention

Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Skinfold thickness
Continuous variable, measured in millimeters (mm)

Secondary Outcome Measures

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

Full Information

First Posted
May 25, 2021
Last Updated
May 25, 2021
Sponsor
Patricia Celestina Ríos Mujica
Collaborators
PROCIENCIA, Consejo Nacional de Ciencia y Tecnología
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1. Study Identification

Unique Protocol Identification Number
NCT04905966
Brief Title
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

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
June 1, 2018 (Actual)
Primary Completion Date
March 30, 2019 (Actual)
Study Completion Date
March 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Patricia Celestina Ríos Mujica
Collaborators
PROCIENCIA, Consejo Nacional de Ciencia y Tecnología

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Childhood Obesity
Keywords
Childhood Obesity, Nutrition Education, Physical Activity, Intervention, Schools

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Four groups of participants received four different interventions: (1) Nutrition education + Physical Activity; (2) Control
Masking
Participant
Masking Description
Three lists of schools were built, according to type of institution and area where the school is located. The first list corresponded to rural public schools, the second to urban public schools and the last to urban private schools. Each of the lists contained the type of institution (public / private), the area where it is located (urban / rural), the name of the school and the district to which it belongs. The schools were masked with an identifier number in order to avoid bias during the assignment to the groups (intervened / control). Schools were selected using a computer based list (...)
Allocation
Randomized
Enrollment
1568 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nutrition education + Physical activity intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Nutrition education and Physical activity intervention
Intervention Description
Schools randomized to the experimental group received nutrition education sessions and physical activity classes.
Primary Outcome Measure Information:
Title
Skinfold thickness
Description
Continuous variable, measured in millimeters (mm)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Fruit and vegetables intake
Description
Continuous variable, measured in servings per day
Time Frame
6 months
Title
Physical activity level
Description
Categorical variable, measured using MET in minutes/week and classified as low, medium and high intensity
Time Frame
6 months
Title
Nutritional status
Description
Categorical variable, measured using BMI/age an classified as undernourished, normal, overweight and obese according to WHO standards
Time Frame
6 months
Title
Waist circumference
Description
Continuous variable, measured in centimeters (cm)
Time Frame
6 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patricia Rios
Organizational Affiliation
IRIS UNCA
Official's Role
Study Director
Facility Information:
Facility Name
Instituto Regional de Investigacion en Salud
City
Coronel Oviedo
State/Province
Caaguazu
ZIP/Postal Code
00000
Country
Paraguay

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Protocol
IPD Sharing Time Frame
all the time
IPD Sharing Access Criteria
investigators

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

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