Ignite Creation Date:
2025-12-25 @ 4:30 AM
Ignite Modification Date:
2025-12-26 @ 3:33 AM
Study NCT ID:
NCT00210418
Status:
COMPLETED
Last Update Posted:
2012-08-30
First Post:
2005-09-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effectiveness of Targeting Food Aid to Malnourished Children Compared to Targeting All Children Under Two Years
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004522', 'term': 'Educational Status'}], 'ancestors': [{'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'}, 'enrollmentInfo': {'count': 1500}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-08', 'completionDateStruct': {'date': '2005-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-08-29', 'studyFirstSubmitDate': '2005-09-13', 'studyFirstSubmitQcDate': '2005-09-13', 'lastUpdatePostDateStruct': {'date': '2012-08-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-21', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean z-scores (height-for-age, weight-for-age, weight-for-height) two years after intervention implemented'}, {'measure': 'Prevalence of undernutrition (stunting, wasting, underweight) two years after implementation of intervention'}], 'secondaryOutcomes': [{'measure': 'Maternal knowledge about child feeding practices recommended through behavioral intervention at 2 years after implementation of intervention;'}, {'measure': 'Feeding practices and other caregiving practices at 2 years after implementation of intervention'}]}, 'conditionsModule': {'keywords': ['Malnutrition', 'Infant nutrition', 'Food, fortified', 'Growth', 'Randomized controlled trials', 'Evaluation studies', 'Haiti'], 'conditions': ['Malnutrition']}, 'referencesModule': {'references': [{'pmid': '15646314', 'type': 'RESULT', 'citation': 'Ruel MT, Menon P, Loechl C, Pelto G. Donated fortified cereal blends improve the nutrient density of traditional complementary foods in Haiti, but iron and zinc gaps remain for infants. Food Nutr Bull. 2004 Dec;25(4):361-76. doi: 10.1177/156482650402500406.'}, {'pmid': '18280329', 'type': 'RESULT', 'citation': 'Ruel MT, Menon P, Habicht JP, Loechl C, Bergeron G, Pelto G, Arimond M, Maluccio J, Michaud L, Hankebo B. Age-based preventive targeting of food assistance and behaviour change and communication for reduction of childhood undernutrition in Haiti: a cluster randomised trial. Lancet. 2008 Feb 16;371(9612):588-95. doi: 10.1016/S0140-6736(08)60271-8.'}, {'pmid': '16060227', 'type': 'RESULT', 'citation': 'Menon P, Ruel MT, Loechl C, Pelto G. From research to program design: use of formative research in Haiti to develop a behavior change communication program to prevent malnutrition. Food Nutr Bull. 2005 Jun;26(2):241-2. doi: 10.1177/156482650502600210. No abstract available.'}, {'pmid': '18287379', 'type': 'RESULT', 'citation': 'Menon P, Mbuya M, Habicht JP, Pelto G, Loechl CU, Ruel MT. Assessing supervisory and motivational factors in the context of a program evaluation in rural Haiti. J Nutr. 2008 Mar;138(3):634-7. doi: 10.1093/jn/138.3.634.'}, {'pmid': '20392883', 'type': 'RESULT', 'citation': 'Donegan S, Maluccio JA, Myers CK, Menon P, Ruel MT, Habicht JP. Two food-assisted maternal and child health nutrition programs helped mitigate the impact of economic hardship on child stunting in Haiti. J Nutr. 2010 Jun;140(6):1139-45. doi: 10.3945/jn.109.114272. Epub 2010 Apr 14.'}]}, 'descriptionModule': {'briefSummary': "The objective of this study is to compare two approaches to targeting donated supplementary food to young children. The study compares the effectiveness of the widely-used curative approach where targeting is based on the child's poor nutritional status to a preventive approach which targets children in poor communities solely on the basis of age and provides supplementary food to all children aged 6-23 months. Cost-effectiveness of the two targeting approaches will also be assessed.", 'detailedDescription': 'Under-nutrition is widespread among young children in poor countries. In many countries one of the programmatic responses has been distribution of supplementary food to under-nourished children and, often, their families. Traditionally, children under five years have been identified based on low weight-for-age or other anthropometric indicators, and those below a certain cut-off have received supplements. Typically this results in supplementation of many children in the 3-5 year age range, since they are most likely to display cumulative deficits in height and weight, and thus fall below the chosen cut-off.\n\nHowever, there has been increasing evidence that the most effective period to ensure benefit from supplementary food is when children are 6 to 24 months of age. This is the period of highest growth velocity among humans and thus a period when most growth faltering occurs.\n\nBased on this evidence, the current study aims to assess the effectiveness and cost-effectiveness of a preventive approach that targets children under 24 months as compared to the traditional "curative" approach that targets malnourished (and usually older) children under the age of 5 years.\n\nThe comparison is made in the programmatic context of a US Title II food aid distribution program implemented by an international non-governmental organization in rural Haiti. This programmatic context is common in many countries that receive assistance from the United States Agency for International Development and other donors. The study has also involved development of new nutrition education materials and tools, aimed at enabling caregivers to prevent malnutrition. In addition, a range of program operational issues will be studied in order to yield results useful to other implementers of similar interventions.\n\nComparison: Comparisons will be made at the level of the program site, with service delivery points randomized either to target food supplements as in the past, based on the child\'s nutritional status, or to target preventively based on age. Pregnant women and lactating women with infants under 6 months of age will receive supplements under both targeting models. Effectiveness will be assessed based on two cross-sectional surveys, at baseline and two years after full implementation of the program.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Family resides in community served by World-Vision Haiti's Maternal and Child Health and Nutrition Program\n\nExclusion Criteria:\n\n* None"}, 'identificationModule': {'nctId': 'NCT00210418', 'briefTitle': 'Effectiveness of Targeting Food Aid to Malnourished Children Compared to Targeting All Children Under Two Years', 'organization': {'class': 'OTHER', 'fullName': 'International Food Policy Research Institute'}, 'officialTitle': 'Prevention or Cure: A Comparison of the Effectiveness of Targeting Food Supplements to Malnourished Children Compared to Universal Targeting of Children Under Two in Haiti', 'orgStudyIdInfo': {'id': '212620-0S-IFPRI'}, 'secondaryIdInfos': [{'id': '81051898'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Preventive targeting', 'description': 'This arm targeted pregnant and lactating women as well as children 6-23.9 months of age to receive BCC and food assistance. A total of 27 months of enrollment in this program arm was possible.', 'interventionNames': ['Dietary Supplement: Fortified food rations', 'Behavioral: Education and communication to improve feeding practices']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Recuperative targeting', 'description': 'This arm targeted pregnant and lactating women as well as mothers of malnourished children (WAZ \\<-2 zscores) between 6 and 59 months of age. A total of 18 months of enrollment was possible in this program arm.', 'interventionNames': ['Dietary Supplement: Fortified food rations', 'Behavioral: Education and communication to improve feeding practices']}], 'interventions': [{'name': 'Fortified food rations', 'type': 'DIETARY_SUPPLEMENT', 'description': "The Fortified food rations were included in both arms, but targeted to all children 6-24 months of age in the 'preventive' arm and to malnourished children (WAZ \\<-2 Z-scores) in the 'recuperative arm. Food rations included Corn-Soy Blend, lentils, oil and wheat.", 'armGroupLabels': ['Preventive targeting', 'Recuperative targeting']}, {'name': 'Education and communication to improve feeding practices', 'type': 'BEHAVIORAL', 'description': "The education and communication to improve infant and young child feeding was an integral part of the intervention. In the preventive arm, this intervention was targeted to pregnant and lactating mothers and mothers of children 0-24 months of age. The education was done using mother's groups In the recuperative arm, the BCC intervention was only targeted to pregnant and lactating women and mothers of malnourished children under the age of five.", 'armGroupLabels': ['Preventive targeting', 'Recuperative targeting']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hinche', 'country': 'Haiti', 'facility': 'World Vision-Haiti', 'geoPoint': {'lat': 19.1409, 'lon': -72.01194}}], 'overallOfficials': [{'name': 'Marie T. Ruel, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'International Food Policy Research Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'International Food Policy Research Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'Cornell University', 'class': 'OTHER'}, {'name': 'Food and Nutrition Technical Assistance Project', 'class': 'UNKNOWN'}, {'name': 'United States Agency for International Development (USAID)', 'class': 'FED'}, {'name': 'World Vision', 'class': 'OTHER'}, {'name': 'Government of Germany', 'class': 'OTHER_GOV'}, {'name': 'United Nations World Food Programme (WFP)', 'class': 'OTHER'}]}}}