Ignite Creation Date:
2025-12-24 @ 7:12 PM
Ignite Modification Date:
2026-02-26 @ 7:47 PM
Study NCT ID:
NCT04788303
Status:
COMPLETED
Last Update Posted:
2023-05-03
First Post:
2021-02-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Meals, Education, and Gardens for In-School Adolescents (MEGA) Project
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000740', 'term': 'Anemia'}], 'ancestors': [{'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000072506', 'term': 'Gardens'}, {'id': 'D004522', 'term': 'Educational Status'}], 'ancestors': [{'id': 'D000383', 'term': 'Agriculture'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}, {'id': 'D000072182', 'term': 'Non-Medical Public and Private Facilities'}, {'id': 'D012959', 'term': 'Socioeconomic Factors'}, {'id': 'D011154', 'term': 'Population Characteristics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Six schools will be randomly assigned to receive the full intervention (school meal, garden, and education), partial intervention (garden and education), or control (standard of care). Community workshops will also be provided to parents of adolescents in full and partial intervention schools.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1232}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2022-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-01', 'studyFirstSubmitDate': '2021-02-20', 'studyFirstSubmitQcDate': '2021-03-04', 'lastUpdatePostDateStruct': {'date': '2023-05-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Anemia status', 'timeFrame': 'Up to one year', 'description': 'Anemia status will be defined using the diagnostic criteria by the World Health Organization. Specifically, the following criteria will be used:\n\n\\< 12 g/dL for adolescent girls and adolescent boys aged 14 yrs and \\< 13 g/dL for adolescent boys aged 15-19 yrs'}], 'secondaryOutcomes': [{'measure': 'Height', 'timeFrame': 'Up to one year', 'description': 'Adolescent height will be measured in centimeters.'}, {'measure': 'Weight', 'timeFrame': 'Up to one year.', 'description': 'Adolescent weight will be measured in kilograms.'}, {'measure': 'BMI', 'timeFrame': 'Up to one year', 'description': 'Adolescent BMI (raw and BMI-for-age z-score based on the WHO adolescent growth standards).'}, {'measure': 'Knowledge of adolescents regarding nutrition and dietary intake', 'timeFrame': 'Up to one year', 'description': "Adolescents' knowledge of nutrition will be assessed by questions that evaluate their levels of nutrition-related knowledge."}, {'measure': 'Attitudes of adolescents regarding nutrition and dietary intake', 'timeFrame': 'Up to one year', 'description': "Adolescents' attitudes of nutrition will be assessed by evaluating their preferences of food groups using Likert scales."}, {'measure': 'Practices of adolescents regarding nutrition and dietary intake', 'timeFrame': 'Up to one year', 'description': 'Nutritional and dietary practices will be assessed using a food frequency questionnaire.'}, {'measure': 'Practices of adolescents regarding water, sanitation, and hygiene', 'timeFrame': 'Up to one year', 'description': "Adolescents' practices of WASH will be assessed by questions that evaluate their WASH-related behaviors such as handwashing."}, {'measure': 'Educational outcomes of adolescents (school attendance)', 'timeFrame': 'Up to one year', 'description': 'School attendance will be measured as number of school days missed per student.'}, {'measure': 'Educational outcomes of adolescents (School retention)', 'timeFrame': 'Up to one year', 'description': 'School retention will be measured as number of students who drop out of school.'}, {'measure': 'Practices of WASH among parents', 'timeFrame': 'Up to one year', 'description': "To be assessed using questions that evaluate parents' practices on water, sanitation, and hygiene."}, {'measure': 'Home gardening practices among parents', 'timeFrame': 'Up to one year', 'description': 'To be assessed using self-reported home gardening practice by parents.'}, {'measure': 'Dietary practice among parents', 'timeFrame': 'Up to one year', 'description': 'To be assessed using a food frequency questionnaire among parents.'}, {'measure': 'Nutrition knowledge among parents', 'timeFrame': 'Up to one year', 'description': "To be assessed using questions that evaluate parents' knowledge on nutrition and dietary intake."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Anemia', 'School garden', 'School lunch', 'Nutrition', 'Adolescent health'], 'conditions': ['Anemia']}, 'referencesModule': {'references': [{'pmid': '35798513', 'type': 'DERIVED', 'citation': 'Wang D, Katalambula LK, Modest AR, Young T, Ismail A, Mwanyika-Sando M, Tinkasimile A, Mosha D, Malero A, Vuai S, Fawzi WW. Meals, Education, and Gardens for In-School Adolescents (MEGA): study protocol for a cluster randomised trial of an integrated adolescent nutrition intervention in Dodoma, Tanzania. BMJ Open. 2022 Jul 7;12(7):e062085. doi: 10.1136/bmjopen-2022-062085.'}]}, 'descriptionModule': {'briefSummary': 'This purpose of this study is to assess effects of a comprehensive, school-based nutrition intervention package on anemia status, anthropometric indicators, school performance/attendance, and development indicators among adolescents, and the knowledge, attitudes, and practices of nutrition, agriculture, and WASH among parents, in Tanzania.', 'detailedDescription': 'The Meals, Education, and Gardens for In-School Adolescents (MEGA) Project aims to implement and evaluate a comprehensive, school-based nutrition intervention package among secondary schools in Dodoma, Tanzania. The intervention will include four primary components: (1) school garden, (2) school meal program, (3) agriculture, nutrition, and water, sanitation, and hygiene (WASH) education, and (4) community workshops.\n\nThis will be a cluster randomized trial with 3 arms, containing two schools each. At the beginning of the academic year, six schools will be randomized to intervention or control. Two schools will receive the full intervention package (school lunch, school garden, and education), two schools will receive the partial intervention package (school garden and education), and two schools will serve as control to receive the standard of care. Community workshops will also be provided to parents of adolescents in full and partial intervention schools.\n\nIn the full intervention schools, all adolescents will receive a midday meal, while a subset of Forms 1 or 2 adolescents will additionally participate in a school gardening program that includes nutrition, agriculture, and water, sanitation, and hygiene (WASH) education, led by selected teachers. Parents of adolescents in full intervention schools will be invited to participate in community workshops on nutrition, hygiene, and agricultural best practices, led by community Agriculture Extension Workers (AEWs).\n\nIn the partial intervention schools, Forms 1 or 2 adolescents will participate in the gardening and education components described above, but will not receive the midday meal. Parents of participating adolescents will also be invited to participate in the community workshops.\n\nAdolescents in control schools will not receive any of these interventions but will be provided with standard of care practices at secondary schools in Dodoma. In addition, teachers in control schools will receive a hard copy of educational materials on nutrition, agriculture, and WASH to enhance their lesson plans. The intervention will take place over the course of one year.\n\nThe goal of the MEGA project is to study the effects of the integrated intervention on the nutrition and health of adolescents and their families in Tanzania. Ultimately, we aim to use the findings from this study to inform the scale-up of future school and community-based interventions to improve nutrition through training, improved crop production, and increased consumption of vegetables.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '14 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'INCLUSION CRITERIA:\n\nAdolescents:\n\n* Adolescents aged 14-17 years\n* Enrolled in secondary school forms 1 or 2 at study initiation\n* Member of one of the selected classes in a participating school\n* Consent provided by the parent\n* Assent provided by the adolescent\n* Fluent in Swahili or English\n\nParents:\n\n* Parent or guardian of participating adolescent\n* Provides informed consent\n* Fluent in Swahili or English\n\nTeachers:\n\n* Teacher facilitating the meal, garden, and/or education interventions\n* Provides informed consent\n* Fluent in Swahili or English\n\nEXCLUSION CRITERIA:\n\nAdolescents:\n\n* No informed consent from parent/guardian or assent from adolescent\n\nParents:\n\n* No informed consent\n\nTeachers:\n\n* No informed consent'}, 'identificationModule': {'nctId': 'NCT04788303', 'acronym': 'MEGA', 'briefTitle': 'Meals, Education, and Gardens for In-School Adolescents (MEGA) Project', 'organization': {'class': 'OTHER', 'fullName': 'Harvard School of Public Health (HSPH)'}, 'officialTitle': 'Meals, Education, and Gardens for In-School Adolescents (MEGA) Project', 'orgStudyIdInfo': {'id': 'CNSG Project'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Full intervention', 'description': 'Full intervention: school meal, garden, education, and community workshops', 'interventionNames': ['Other: School meal, garden, education, and community workshops']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Partial intervention', 'description': 'Partial intervention: garden, education, and community workshops', 'interventionNames': ['Other: Garden, education, and community workshops']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Control: standard of care'}], 'interventions': [{'name': 'School meal, garden, education, and community workshops', 'type': 'OTHER', 'otherNames': ['Full intervention package'], 'description': 'School meal: midday meal provided at intervention schools\n\nSchool garden: garden used to grow crops (which will be used to supplement the school meal in the full intervention schools)\n\nEducation: agriculture, nutrition, and water, sanitation, and hygiene (WASH) curriculum\n\nCommunity workshops: Led by agricultural extension workers and open to community members, the community workshops will cover nutrition messages, agricultural messages, and hands-on activities on nutrition, agriculture, and WASH.', 'armGroupLabels': ['Full intervention']}, {'name': 'Garden, education, and community workshops', 'type': 'OTHER', 'otherNames': ['Partial intervention package'], 'description': 'School garden: garden used to grow crops\n\nEducation: agriculture, nutrition, and water, sanitation, and hygiene (WASH) curriculum\n\nCommunity workshops: Led by agricultural extension workers and open to community members, the community workshops will cover nutrition messages, agricultural messages, and hands-on activities on nutrition, agriculture, and WASH.', 'armGroupLabels': ['Partial intervention']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Dodoma', 'country': 'Tanzania', 'facility': 'University of Dodoma', 'geoPoint': {'lat': -6.17221, 'lon': 35.73947}}], 'overallOfficials': [{'name': 'Wafaie W Fawzi, MBBS, MPH, MS, DrPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Harvard School of Public Health (HSPH)'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Harvard School of Public Health (HSPH)', 'class': 'OTHER'}, 'collaborators': [{'name': 'Africa Academy for Public Health', 'class': 'OTHER'}, {'name': 'University of Dodoma', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Nutrition, Epidemiology, and Global Health', 'investigatorFullName': 'Wafaie Fawzi', 'investigatorAffiliation': 'Harvard School of Public Health (HSPH)'}}}}