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

NCT04905966 | Completed

• 1 other identifier: PINV15426
• Study Type: interventional
• Target: 1,568
• Locations: 1 country
• Sites: 1

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.

Conditions

Childhood Obesity

Keywords

Childhood Obesity, Nutrition Education, Physical Activity; Intervention, Schools

Outcome Measures

Primary Outcomes (1)

• Skinfold thickness

  Continuous variable, measured in millimeters (mm)

  6 months

Secondary Outcomes (4)

• Fruit and vegetables intake

  6 months

• Physical activity level

  6 months

• Nutritional status

  6 months

• Waist circumference

  6 months

Study Arms (2)

Nutrition education + Physical activity intervention

EXPERIMENTAL

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

Control

NO INTERVENTION

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.

Interventions

Nutrition education and Physical activity intervention BEHAVIORAL

Schools randomized to the experimental group received nutrition education sessions and physical activity classes.

Nutrition education + Physical activity intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Patricia Celestina Ríos Mujica: lead
• PROCIENCIA, Consejo Nacional de Ciencia y Tecnología: collaborator

Study Sites (1)

Instituto Regional de Investigacion en Salud

Coronel Oviedo, Caaguazú Department, 00000, Paraguay

Location

MeSH Terms

Conditions

Pediatric Obesity; Motor Activity

Interventions

Nutrition Assessment

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Patricia Rios

  IRIS UNCA

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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 (...)
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Field Coordinator

Model Details: Four groups of participants received four different interventions: (1) Nutrition education + Physical Activity; (2) Control

Study Record Dates

• First Submitted: May 25, 2021
• First Posted: May 28, 2021
• Study Start: June 1, 2018
• Primary Completion: March 30, 2019
• Study Completion: March 30, 2019
• Last Updated: May 28, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: all the time
• Access Criteria: investigators

Locations

PA (1)