Ignite Creation Date:
2025-12-24 @ 7:55 PM
Ignite Modification Date:
2026-01-23 @ 4:03 PM
Study NCT ID:
NCT03689504
Status:
COMPLETED
Last Update Posted:
2021-11-09
First Post:
2018-09-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluating a Family-based Nutrition and Garden Intervention in Rural Guatemala
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D044342', 'term': 'Malnutrition'}], 'ancestors': [{'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'peter@wuqukawoq.org', 'phone': '011-502-4958-1253', 'title': 'Peter Rohloff, Chief Medical Officer', 'organization': "Wuqu' Kawoq"}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '12 months', 'eventGroups': [{'id': 'EG000', 'title': 'Standard of Care', 'description': 'The standard of care is an intensive individualized home-based nutrition education program, together with a home food ration and micronutrient supplement, delivered by frontline workers for 6 months.\n\nStandard of care nutrition support: Subjects will be provided with a standard food ration and with a multiple micronutrient powder (Chispitas) or lipid-based nutrient supplement (Nutributter)\n\nHome-based nutrition education: Health promoters will use 24-hour dietary recall information to assess meal frequency and dietary diversity and then provide tailored nutrition coaching to parents.', 'otherNumAtRisk': 70, 'deathsNumAtRisk': 70, 'otherNumAffected': 0, 'seriousNumAtRisk': 70, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Home Garden Intervention', 'description': 'This arm adds an 8 month individualized home-based family garden intervention to the existing standard of care (home-based nutrition education)\n\nStandard of care nutrition support: Subjects will be provided with a standard food ration and with a multiple micronutrient powder (Chispitas) or lipid-based nutrient supplement (Nutributter)\n\nHome-based nutrition education: Health promoters will use 24-hour dietary recall information to assess meal frequency and dietary diversity and then provide tailored nutrition coaching to parents.\n\nHome-based family gardening: Health promoters will facilitate the building and maintenance of a family home garden using a square foot or container gardening method.', 'otherNumAtRisk': 70, 'deathsNumAtRisk': 70, 'otherNumAffected': 0, 'seriousNumAtRisk': 70, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Mean Number of Food Groups Consumed Per Day at 6 Months - Child', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard of Care', 'description': 'The standard of care is an intensive individualized home-based nutrition education program, together with a home food ration and micronutrient supplement, delivered by frontline workers for 6 months.\n\nStandard of care nutrition support: Subjects will be provided with a standard food ration and with a multiple micronutrient powder (Chispitas) or lipid-based nutrient supplement (Nutributter)\n\nHome-based nutrition education: Health promoters will use 24-hour dietary recall information to assess meal frequency and dietary diversity and then provide tailored nutrition coaching to parents.'}, {'id': 'OG001', 'title': 'Home Garden Intervention', 'description': 'This arm adds an 8 month individualized home-based family garden intervention to the existing standard of care (home-based nutrition education)\n\nStandard of care nutrition support: Subjects will be provided with a standard food ration and with a multiple micronutrient powder (Chispitas) or lipid-based nutrient supplement (Nutributter)\n\nHome-based nutrition education: Health promoters will use 24-hour dietary recall information to assess meal frequency and dietary diversity and then provide tailored nutrition coaching to parents.\n\nHome-based family gardening: Health promoters will facilitate the building and maintenance of a family home garden using a square foot or container gardening method.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.6', 'spread': '1.84', 'groupId': 'OG000'}, {'value': '1.29', 'spread': '1.59', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 6 months', 'description': 'Calculated from the World Health Organization Infant and Young Child Feeding Indicators 24 hour diet recall tool', 'unitOfMeasure': 'food groups', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Mean Number of Solid Meals Consumed Per Day at 6 Months - Child', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard of Care', 'description': 'The standard of care is an intensive individualized home-based nutrition education program, together with a home food ration and micronutrient supplement, delivered by frontline workers for 6 months.\n\nStandard of care nutrition support: Subjects will be provided with a standard food ration and with a multiple micronutrient powder (Chispitas) or lipid-based nutrient supplement (Nutributter)\n\nHome-based nutrition education: Health promoters will use 24-hour dietary recall information to assess meal frequency and dietary diversity and then provide tailored nutrition coaching to parents.'}, {'id': 'OG001', 'title': 'Home Garden Intervention', 'description': 'This arm adds an 8 month individualized home-based family garden intervention to the existing standard of care (home-based nutrition education)\n\nStandard of care nutrition support: Subjects will be provided with a standard food ration and with a multiple micronutrient powder (Chispitas) or lipid-based nutrient supplement (Nutributter)\n\nHome-based nutrition education: Health promoters will use 24-hour dietary recall information to assess meal frequency and dietary diversity and then provide tailored nutrition coaching to parents.\n\nHome-based family gardening: Health promoters will facilitate the building and maintenance of a family home garden using a square foot or container gardening method.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.81', 'spread': '1.61', 'groupId': 'OG000'}, {'value': '1.11', 'spread': '1.45', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 6 months', 'description': 'Calculated from the World Health Organization Infant and Young Child Feeding Indicators 24 hour diet recall tool', 'unitOfMeasure': 'solid meals', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Raw Household Food Insecurity Score at 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard of Care', 'description': 'The standard of care is an intensive individualized home-based nutrition education program, together with a home food ration and micronutrient supplement, delivered by frontline workers for 6 months.\n\nStandard of care nutrition support: Subjects will be provided with a standard food ration and with a multiple micronutrient powder (Chispitas) or lipid-based nutrient supplement (Nutributter)\n\nHome-based nutrition education: Health promoters will use 24-hour dietary recall information to assess meal frequency and dietary diversity and then provide tailored nutrition coaching to parents.'}, {'id': 'OG001', 'title': 'Home Garden Intervention', 'description': 'This arm adds an 8 month individualized home-based family garden intervention to the existing standard of care (home-based nutrition education)\n\nStandard of care nutrition support: Subjects will be provided with a standard food ration and with a multiple micronutrient powder (Chispitas) or lipid-based nutrient supplement (Nutributter)\n\nHome-based nutrition education: Health promoters will use 24-hour dietary recall information to assess meal frequency and dietary diversity and then provide tailored nutrition coaching to parents.\n\nHome-based family gardening: Health promoters will facilitate the building and maintenance of a family home garden using a square foot or container gardening method.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.55', 'spread': '1.86', 'groupId': 'OG000'}, {'value': '-0.84', 'spread': '2.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 6 months', 'description': "Standardized food insecurity score, using the Food and Agriculture Organization's Global Food Insecurity Experience Scale (possible score range 0-8), higher scores indicate more food insecurity", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Mean Number of Food Groups Consumed Per Day at 6 Months - Female Head of Household', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard of Care', 'description': 'The standard of care is an intensive individualized home-based nutrition education program, together with a home food ration and micronutrient supplement, delivered by frontline workers for 6 months.\n\nStandard of care nutrition support: Subjects will be provided with a standard food ration and with a multiple micronutrient powder (Chispitas) or lipid-based nutrient supplement (Nutributter)\n\nHome-based nutrition education: Health promoters will use 24-hour dietary recall information to assess meal frequency and dietary diversity and then provide tailored nutrition coaching to parents.'}, {'id': 'OG001', 'title': 'Home Garden Intervention', 'description': 'This arm adds an 8 month individualized home-based family garden intervention to the existing standard of care (home-based nutrition education)\n\nStandard of care nutrition support: Subjects will be provided with a standard food ration and with a multiple micronutrient powder (Chispitas) or lipid-based nutrient supplement (Nutributter)\n\nHome-based nutrition education: Health promoters will use 24-hour dietary recall information to assess meal frequency and dietary diversity and then provide tailored nutrition coaching to parents.\n\nHome-based family gardening: Health promoters will facilitate the building and maintenance of a family home garden using a square foot or container gardening method.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.01', 'spread': '1.88', 'groupId': 'OG000'}, {'value': '0.42', 'spread': '1.75', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 6 months', 'description': "Calculated from the Food and Agriculture Organization's Minimum Dietary Diversity for Women dietary recall", 'unitOfMeasure': 'food groups', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Height/Length for Age Z Score From Baseline to 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard of Care', 'description': 'The standard of care is an intensive individualized home-based nutrition education program, together with a home food ration and micronutrient supplement, delivered by frontline workers for 6 months.\n\nStandard of care nutrition support: Subjects will be provided with a standard food ration and with a multiple micronutrient powder (Chispitas) or lipid-based nutrient supplement (Nutributter)\n\nHome-based nutrition education: Health promoters will use 24-hour dietary recall information to assess meal frequency and dietary diversity and then provide tailored nutrition coaching to parents.'}, {'id': 'OG001', 'title': 'Home Garden Intervention', 'description': 'This arm adds an 8 month individualized home-based family garden intervention to the existing standard of care (home-based nutrition education)\n\nStandard of care nutrition support: Subjects will be provided with a standard food ration and with a multiple micronutrient powder (Chispitas) or lipid-based nutrient supplement (Nutributter)\n\nHome-based nutrition education: Health promoters will use 24-hour dietary recall information to assess meal frequency and dietary diversity and then provide tailored nutrition coaching to parents.\n\nHome-based family gardening: Health promoters will facilitate the building and maintenance of a family home garden using a square foot or container gardening method.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.21', 'spread': '0.49', 'groupId': 'OG000'}, {'value': '-0.07', 'spread': '0.51', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 months (baseline), 6 months', 'description': 'These are differences from 0 to 6 months (baseline to 6 months of intervention) z-scores calculated against the World Health Organization pediatric growth reference population (https://www.who.int/tools/child-growth-standards/standards)', 'unitOfMeasure': 'change in Z score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Weight for Age Z Score From Baseline to 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard of Care', 'description': 'The standard of care is an intensive individualized home-based nutrition education program, together with a home food ration and micronutrient supplement, delivered by frontline workers for 6 months.\n\nStandard of care nutrition support: Subjects will be provided with a standard food ration and with a multiple micronutrient powder (Chispitas) or lipid-based nutrient supplement (Nutributter)\n\nHome-based nutrition education: Health promoters will use 24-hour dietary recall information to assess meal frequency and dietary diversity and then provide tailored nutrition coaching to parents.'}, {'id': 'OG001', 'title': 'Home Garden Intervention', 'description': 'This arm adds an 8 month individualized home-based family garden intervention to the existing standard of care (home-based nutrition education)\n\nStandard of care nutrition support: Subjects will be provided with a standard food ration and with a multiple micronutrient powder (Chispitas) or lipid-based nutrient supplement (Nutributter)\n\nHome-based nutrition education: Health promoters will use 24-hour dietary recall information to assess meal frequency and dietary diversity and then provide tailored nutrition coaching to parents.\n\nHome-based family gardening: Health promoters will facilitate the building and maintenance of a family home garden using a square foot or container gardening method.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.22', 'spread': '0.39', 'groupId': 'OG000'}, {'value': '-0.12', 'spread': '0.29', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 months (Baseline), 6 months', 'description': 'These are differences from 0 to 6 months (baseline to 6 months of intervention) z-scores calculated against the World Health Organization pediatric growth reference population (https://www.who.int/tools/child-growth-standards/standards)', 'unitOfMeasure': 'Change in Z score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Weight for Height/Length Z Score From Baseline to 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard of Care', 'description': 'The standard of care is an intensive individualized home-based nutrition education program, together with a home food ration and micronutrient supplement, delivered by frontline workers for 6 months.\n\nStandard of care nutrition support: Subjects will be provided with a standard food ration and with a multiple micronutrient powder (Chispitas) or lipid-based nutrient supplement (Nutributter)\n\nHome-based nutrition education: Health promoters will use 24-hour dietary recall information to assess meal frequency and dietary diversity and then provide tailored nutrition coaching to parents.'}, {'id': 'OG001', 'title': 'Home Garden Intervention', 'description': 'This arm adds an 8 month individualized home-based family garden intervention to the existing standard of care (home-based nutrition education)\n\nStandard of care nutrition support: Subjects will be provided with a standard food ration and with a multiple micronutrient powder (Chispitas) or lipid-based nutrient supplement (Nutributter)\n\nHome-based nutrition education: Health promoters will use 24-hour dietary recall information to assess meal frequency and dietary diversity and then provide tailored nutrition coaching to parents.\n\nHome-based family gardening: Health promoters will facilitate the building and maintenance of a family home garden using a square foot or container gardening method.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.38', 'spread': '0.64', 'groupId': 'OG000'}, {'value': '-0.24', 'spread': '0.54', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 6 months', 'description': 'These are differences from 0 to 6 months (baseline to 6 months of intervention) z-scores calculated against the World Health Organization pediatric growth reference population (https://www.who.int/tools/child-growth-standards/standards)', 'unitOfMeasure': 'Change in Z score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mean Change in Household Crop Species From Baseline to 6 Months Diversity Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard of Care', 'description': 'The standard of care is an intensive individualized home-based nutrition education program, together with a home food ration and micronutrient supplement, delivered by frontline workers for 6 months.\n\nStandard of care nutrition support: Subjects will be provided with a standard food ration and with a multiple micronutrient powder (Chispitas) or lipid-based nutrient supplement (Nutributter)\n\nHome-based nutrition education: Health promoters will use 24-hour dietary recall information to assess meal frequency and dietary diversity and then provide tailored nutrition coaching to parents.'}, {'id': 'OG001', 'title': 'Home Garden Intervention', 'description': 'This arm adds an 8 month individualized home-based family garden intervention to the existing standard of care (home-based nutrition education)\n\nStandard of care nutrition support: Subjects will be provided with a standard food ration and with a multiple micronutrient powder (Chispitas) or lipid-based nutrient supplement (Nutributter)\n\nHome-based nutrition education: Health promoters will use 24-hour dietary recall information to assess meal frequency and dietary diversity and then provide tailored nutrition coaching to parents.\n\nHome-based family gardening: Health promoters will facilitate the building and maintenance of a family home garden using a square foot or container gardening method.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.1', 'spread': '4.15', 'groupId': 'OG000'}, {'value': '4.62', 'spread': '4.66', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 6 months', 'description': 'Raw count of total crop species cultivated in the home', 'unitOfMeasure': 'crop species', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Standard of Care', 'description': 'The standard of care is an intensive individualized home-based nutrition education program, together with a home food ration and micronutrient supplement, delivered by frontline workers for 6 months.\n\nStandard of care nutrition support: Subjects will be provided with a standard food ration and with a multiple micronutrient powder (Chispitas) or lipid-based nutrient supplement (Nutributter)\n\nHome-based nutrition education: Health promoters will use 24-hour dietary recall information to assess meal frequency and dietary diversity and then provide tailored nutrition coaching to parents.'}, {'id': 'FG001', 'title': 'Home Garden Intervention', 'description': 'This arm adds an 8 month individualized home-based family garden intervention to the existing standard of care (home-based nutrition education)\n\nStandard of care nutrition support: Subjects will be provided with a standard food ration and with a multiple micronutrient powder (Chispitas) or lipid-based nutrient supplement (Nutributter)\n\nHome-based nutrition education: Health promoters will use 24-hour dietary recall information to assess meal frequency and dietary diversity and then provide tailored nutrition coaching to parents.\n\nHome-based family gardening: Health promoters will facilitate the building and maintenance of a family home garden using a square foot or container gardening method.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '70'}, {'groupId': 'FG001', 'numSubjects': '70'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '65'}, {'groupId': 'FG001', 'numSubjects': '70'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'BG000'}, {'value': '70', 'groupId': 'BG001'}, {'value': '140', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Standard of Care', 'description': 'The standard of care is an intensive individualized home-based nutrition education program, together with a home food ration and micronutrient supplement, delivered by frontline workers for 6 months.\n\nStandard of care nutrition support: Subjects will be provided with a standard food ration and with a multiple micronutrient powder (Chispitas) or lipid-based nutrient supplement (Nutributter)\n\nHome-based nutrition education: Health promoters will use 24-hour dietary recall information to assess meal frequency and dietary diversity and then provide tailored nutrition coaching to parents.'}, {'id': 'BG001', 'title': 'Home Garden Intervention', 'description': 'This arm adds an 8 month individualized home-based family garden intervention to the existing standard of care (home-based nutrition education)\n\nStandard of care nutrition support: Subjects will be provided with a standard food ration and with a multiple micronutrient powder (Chispitas) or lipid-based nutrient supplement (Nutributter)\n\nHome-based nutrition education: Health promoters will use 24-hour dietary recall information to assess meal frequency and dietary diversity and then provide tailored nutrition coaching to parents.\n\nHome-based family gardening: Health promoters will facilitate the building and maintenance of a family home garden using a square foot or container gardening method.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'BG000'}, {'value': '70', 'groupId': 'BG001'}, {'value': '140', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '376', 'groupId': 'BG000', 'lowerLimit': '265', 'upperLimit': '524'}, {'value': '343', 'groupId': 'BG001', 'lowerLimit': '259', 'upperLimit': '471'}, {'value': '353', 'groupId': 'BG002', 'lowerLimit': '262', 'upperLimit': '502'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'days', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'BG000'}, {'value': '70', 'groupId': 'BG001'}, {'value': '140', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '79', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Maya ethnicity/language preference', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'BG000'}, {'value': '70', 'groupId': 'BG001'}, {'value': '139', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '65', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '133', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'data missing'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Guatemala', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'BG000'}, {'value': '70', 'groupId': 'BG001'}, {'value': '140', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '70', 'groupId': 'BG000'}, {'value': '70', 'groupId': 'BG001'}, {'value': '140', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Length for age Z score', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'BG000'}, {'value': '70', 'groupId': 'BG001'}, {'value': '140', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '-3.05', 'groupId': 'BG000', 'lowerLimit': '-3.57', 'upperLimit': '-2.68'}, {'value': '-3.20', 'groupId': 'BG001', 'lowerLimit': '-3.7', 'upperLimit': '-2.68'}, {'value': '-3.15', 'groupId': 'BG002', 'lowerLimit': '-3.64', 'upperLimit': '-2.68'}]}]}], 'paramType': 'MEDIAN', 'description': 'These are z-scores calculated against the World Health Organization pediatric growth reference population (https://www.who.int/tools/child-growth-standards/standards)', 'unitOfMeasure': 'Z score', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Weight for age Z score', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'BG000'}, {'value': '70', 'groupId': 'BG001'}, {'value': '140', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '-1.55', 'groupId': 'BG000', 'lowerLimit': '-2.07', 'upperLimit': '-1.25'}, {'value': '-1.58', 'groupId': 'BG001', 'lowerLimit': '-2.23', 'upperLimit': '-1.07'}, {'value': '-1.56', 'groupId': 'BG002', 'lowerLimit': '-2.14', 'upperLimit': '-1.07'}]}]}], 'paramType': 'MEDIAN', 'description': 'These are z-scores calculated against the World Health Organization pediatric growth reference population (https://www.who.int/tools/child-growth-standards/standards)', 'unitOfMeasure': 'Z score', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Weight for length Z score', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'BG000'}, {'value': '70', 'groupId': 'BG001'}, {'value': '140', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0.18', 'groupId': 'BG000', 'lowerLimit': '-0.30', 'upperLimit': '0.75'}, {'value': '0.32', 'groupId': 'BG001', 'lowerLimit': '-0.18', 'upperLimit': '0.86'}, {'value': '0.3', 'groupId': 'BG002', 'lowerLimit': '-0.28', 'upperLimit': '0.79'}]}]}], 'paramType': 'MEDIAN', 'description': 'These are z-scores calculated against the World Health Organization pediatric growth reference population (https://www.who.int/tools/child-growth-standards/standards)', 'unitOfMeasure': 'Z score', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Minimum acceptable diet', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'BG000'}, {'value': '70', 'groupId': 'BG001'}, {'value': '140', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'This is a composite diet quality measure developed by the World Health Organization in the technical manual Infant and Young Child Feeding Indicators. It references achieving both minimum recommended food group consumption and solid meal consumption within a 24 hour recall period, with adjustments for age and breastfeeding status. Full details: https://www.who.int/publications/i/item/9789240018389', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-12-20', 'size': 369011, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-07-14T13:21', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 140}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2020-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-11', 'studyFirstSubmitDate': '2018-09-26', 'resultsFirstSubmitDate': '2021-07-14', 'studyFirstSubmitQcDate': '2018-09-27', 'lastUpdatePostDateStruct': {'date': '2021-11-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-10-11', 'studyFirstPostDateStruct': {'date': '2018-09-28', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-11-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Mean Number of Food Groups Consumed Per Day at 6 Months - Child', 'timeFrame': 'Baseline, 6 months', 'description': 'Calculated from the World Health Organization Infant and Young Child Feeding Indicators 24 hour diet recall tool'}, {'measure': 'Change From Baseline in Mean Number of Solid Meals Consumed Per Day at 6 Months - Child', 'timeFrame': 'Baseline, 6 months', 'description': 'Calculated from the World Health Organization Infant and Young Child Feeding Indicators 24 hour diet recall tool'}, {'measure': 'Change From Baseline in Raw Household Food Insecurity Score at 6 Months', 'timeFrame': 'Baseline, 6 months', 'description': "Standardized food insecurity score, using the Food and Agriculture Organization's Global Food Insecurity Experience Scale (possible score range 0-8), higher scores indicate more food insecurity"}, {'measure': 'Change From Baseline in Mean Number of Food Groups Consumed Per Day at 6 Months - Female Head of Household', 'timeFrame': 'Baseline, 6 months', 'description': "Calculated from the Food and Agriculture Organization's Minimum Dietary Diversity for Women dietary recall"}], 'secondaryOutcomes': [{'measure': 'Change in Height/Length for Age Z Score From Baseline to 6 Months', 'timeFrame': '0 months (baseline), 6 months', 'description': 'These are differences from 0 to 6 months (baseline to 6 months of intervention) z-scores calculated against the World Health Organization pediatric growth reference population (https://www.who.int/tools/child-growth-standards/standards)'}, {'measure': 'Change in Weight for Age Z Score From Baseline to 6 Months', 'timeFrame': '0 months (Baseline), 6 months', 'description': 'These are differences from 0 to 6 months (baseline to 6 months of intervention) z-scores calculated against the World Health Organization pediatric growth reference population (https://www.who.int/tools/child-growth-standards/standards)'}, {'measure': 'Change in Weight for Height/Length Z Score From Baseline to 6 Months', 'timeFrame': 'Baseline, 6 months', 'description': 'These are differences from 0 to 6 months (baseline to 6 months of intervention) z-scores calculated against the World Health Organization pediatric growth reference population (https://www.who.int/tools/child-growth-standards/standards)'}, {'measure': 'Mean Change in Household Crop Species From Baseline to 6 Months Diversity Score', 'timeFrame': 'Baseline, 6 months', 'description': 'Raw count of total crop species cultivated in the home'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Guatemala', 'indigenous', 'dietary diversity', 'chronic malnutrition', 'Maya', 'agriculture', 'behavior change', 'food insecurity'], 'conditions': ['Malnutrition', 'Dietary Modification']}, 'descriptionModule': {'briefSummary': "This is a pilot quasi-experimental study to evaluate the impact of adding a family garden intervention to an existing wrap-around nutrition intervention for children with chronic malnutrition and their family. The existing nutrition intervention is provided by community health workers affiliated with Wuqu' Kawoq \\| Maya Health Alliance. A single community in rural Guatemala will participate in the intervention, with the goal to recruit approximately 70 families in the combined nutrition/garden intervention. A nearby community, also participating in the nutrition intervention, will serve as a nonrandom contemporaneous control.\n\nAims of the study include:\n\n1. Evaluate the impact of the garden intervention on maternal and child dietary diversity, child growth and household food insecurity.\n2. Use the Reach Effectiveness Adoption Implementation Maintenance (RE-AIM) framework to conduct a preliminary implementation analysis, to guide a future, well-controlled study."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '24 Months', 'minimumAge': '6 Months', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Children who are already scheduled to be enrolled in Maya Health Alliance's intensive home-based nutrition program (non-investigational, standard of care) who are 6-24 months of age at the time of enrollment with a height-for-age Z scores of \\<= -2.5\n* At least one caregiver willing to provide written informed consent\n* Caregiver of a child enrolled in the study (for caregiver/head of household outcomes), including women who may be pregnant\n* Planned residence in the study area for the next 18 months\n\nExclusion Criteria:\n\n* Children with acute malnutrition (weight for length Z scores of \\<= -2.0)\n* Children with a severe medical illness that affects growth (e.g., heart disease, kidney disease, genetic condition) as determined by a Maya Health Alliance staff physician.\n* Caregivers with cognitive impairments that prevent them from being able to provide informed consent"}, 'identificationModule': {'nctId': 'NCT03689504', 'briefTitle': 'Evaluating a Family-based Nutrition and Garden Intervention in Rural Guatemala', 'organization': {'class': 'OTHER', 'fullName': "Wuqu' Kawoq, Maya Health Alliance"}, 'officialTitle': 'Evaluating a Family-based Nutrition and Garden Intervention in Rural Guatemala', 'orgStudyIdInfo': {'id': 'WK-2018-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard of Care', 'description': 'The standard of care is an intensive individualized home-based nutrition education program, together with a home food ration and micronutrient supplement, delivered by frontline workers for 6 months.', 'interventionNames': ['Dietary Supplement: Standard of care nutrition support', 'Behavioral: Home-based nutrition education']}, {'type': 'EXPERIMENTAL', 'label': 'Home Garden Intervention', 'description': 'This arm adds an 8 month individualized home-based family garden intervention to the existing standard of care (home-based nutrition education)', 'interventionNames': ['Dietary Supplement: Standard of care nutrition support', 'Behavioral: Home-based nutrition education', 'Behavioral: Home-based family gardening']}], 'interventions': [{'name': 'Standard of care nutrition support', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Subjects will be provided with a standard food ration and with a multiple micronutrient powder (Chispitas) or lipid-based nutrient supplement (Nutributter)', 'armGroupLabels': ['Home Garden Intervention', 'Standard of Care']}, {'name': 'Home-based nutrition education', 'type': 'BEHAVIORAL', 'description': 'Health promoters will use 24-hour dietary recall information to assess meal frequency and dietary diversity and then provide tailored nutrition coaching to parents.', 'armGroupLabels': ['Home Garden Intervention', 'Standard of Care']}, {'name': 'Home-based family gardening', 'type': 'BEHAVIORAL', 'description': 'Health promoters will facilitate the building and maintenance of a family home garden using a square foot or container gardening method.', 'armGroupLabels': ['Home Garden Intervention']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tecpán Guatemala', 'state': 'Departamento de Chimaltenango', 'country': 'Guatemala', 'facility': "Wuqu' Kawoq", 'geoPoint': {'lat': 14.76181, 'lon': -90.99247}}], 'overallOfficials': [{'name': 'Peter Rohloff, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Wuqu' Kawoq"}, {'name': 'Beth Jimenez, RDN PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of New Mexico'}, {'name': 'Andrea Guzman, RDN', 'role': 'STUDY_DIRECTOR', 'affiliation': "Wuqu' Kawoq"}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ANALYTIC_CODE'], 'timeFrame': 'Supporting data will be shared indefinitely on public data repositories at the time of manuscript publication.', 'ipdSharing': 'YES', 'description': 'Fully de-identified demographic, clinical, and outcomes will be made available on a public data repository after completion of primary analysis and at the time of publication of results manuscripts.', 'accessCriteria': 'Publicly available'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Wuqu' Kawoq, Maya Health Alliance", 'class': 'OTHER'}, 'collaborators': [{'name': 'Academy of Nutrition and Dietetics', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}