Ignite Creation Date:
2025-12-24 @ 4:18 PM
Ignite Modification Date:
2025-12-28 @ 7:17 AM
Study NCT ID:
NCT04905966
Status:
COMPLETED
Last Update Posted:
2021-05-28
First Post:
2021-05-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of a Physical Activity and Nutrition Education Intervention on Obesity Prevalence in Schoolchildren
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D063766', 'term': 'Pediatric Obesity'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015596', 'term': 'Nutrition Assessment'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D015991', 'term': 'Epidemiologic Measurements'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': '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.\n\nEach 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 (...)'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Four groups of participants received four different interventions: (1) Nutrition education + Physical Activity; (2) Control'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1568}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2019-03-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-25', 'studyFirstSubmitDate': '2021-05-25', 'studyFirstSubmitQcDate': '2021-05-25', 'lastUpdatePostDateStruct': {'date': '2021-05-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Skinfold thickness', 'timeFrame': '6 months', 'description': 'Continuous variable, measured in millimeters (mm)'}], 'secondaryOutcomes': [{'measure': 'Fruit and vegetables intake', 'timeFrame': '6 months', 'description': 'Continuous variable, measured in servings per day'}, {'measure': 'Physical activity level', 'timeFrame': '6 months', 'description': 'Categorical variable, measured using MET in minutes/week and classified as low, medium and high intensity'}, {'measure': 'Nutritional status', 'timeFrame': '6 months', 'description': 'Categorical variable, measured using BMI/age an classified as undernourished, normal, overweight and obese according to WHO standards'}, {'measure': 'Waist circumference', 'timeFrame': '6 months', 'description': 'Continuous variable, measured in centimeters (cm)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Childhood Obesity, Nutrition Education, Physical Activity', 'Intervention, Schools'], 'conditions': ['Childhood Obesity']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nPoor 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.\n\nThe 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.\n\nIt 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Being public or private schools of the 22 districts of Caaguazú Department\n* Having a minimum of 100 students in each of the three grades of second level of basic school education during 2017 school year\n* Having physical education teachers\n\nExclusion Criteria:\n\n* Schools that had only one school shift\n* Schools that expressed their refusal to participate'}, 'identificationModule': {'nctId': 'NCT04905966', 'briefTitle': 'Effect of a Physical Activity and Nutrition Education Intervention on Obesity Prevalence in Schoolchildren', 'organization': {'class': 'OTHER', 'fullName': 'Instituto Regional de Investigación en Salud "Kaneo Shibata" UNCA'}, 'officialTitle': 'Effect of a Physical Activity and Nutrition Education Intervention on Obesity Prevalence in Schoolchildren From Caaguazu Department, Paraguay: A Clustered Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'PINV15426'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nutrition education + Physical activity intervention', '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.", 'interventionNames': ['Behavioral: Nutrition education and Physical activity intervention']}, {'type': 'NO_INTERVENTION', 'label': 'Control', '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.'}], 'interventions': [{'name': 'Nutrition education and Physical activity intervention', 'type': 'BEHAVIORAL', 'description': 'Schools randomized to the experimental group received nutrition education sessions and physical activity classes.', 'armGroupLabels': ['Nutrition education + Physical activity intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00000', 'city': 'Coronel Oviedo', 'state': 'Caaguazú Department', 'country': 'Paraguay', 'facility': 'Instituto Regional de Investigacion en Salud', 'geoPoint': {'lat': -25.44613, 'lon': -56.43928}}], 'overallOfficials': [{'name': 'Patricia Rios', 'role': 'STUDY_DIRECTOR', 'affiliation': 'IRIS UNCA'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'all the time', 'ipdSharing': 'YES', 'description': 'Protocol', 'accessCriteria': 'investigators'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Patricia Celestina Ríos Mujica', 'class': 'OTHER'}, 'collaborators': [{'name': 'PROCIENCIA, Consejo Nacional de Ciencia y Tecnología', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Field Coordinator', 'investigatorFullName': 'Patricia Celestina Ríos Mujica', 'investigatorAffiliation': 'Instituto Regional de Investigación en Salud "Kaneo Shibata" UNCA'}}}}