Ignite Creation Date:
2025-12-25 @ 4:30 AM
Ignite Modification Date:
2026-02-26 @ 12:38 AM
Study NCT ID:
NCT03299218
Status:
COMPLETED
Last Update Posted:
2020-03-19
First Post:
2017-08-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of SNF, Cash and BCC to Prevent Stunting Among Children 6-24 Months in Rahim Yar Khan, Pakistan
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006130', 'term': 'Growth Disorders'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D053446', 'term': 'CASP8 and FADD-Like Apoptosis Regulating Protein'}], 'ancestors': [{'id': 'D053418', 'term': 'Death Domain Receptor Signaling Adaptor Proteins'}, {'id': 'D048868', 'term': 'Adaptor Proteins, Signal Transducing'}, {'id': 'D047908', 'term': 'Intracellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D047988', 'term': 'Tumor Necrosis Factor Receptor-Associated Peptides and Proteins'}, {'id': 'D051017', 'term': 'Apoptosis Regulatory Proteins'}, {'id': 'D002352', 'term': 'Carrier Proteins'}, {'id': 'D011506', 'term': 'Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'FACTORIAL', 'interventionModelDescription': '1. Control Group\n2. Cash-based transfers only by BISP\n3. Cash-based transfers and Social \\& behaviour change communication (SBCC)\n4. Cash-based transfer and SNF\n5. Cash-based transfers, SNF and SBCC'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2179}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-05-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2019-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-18', 'studyFirstSubmitDate': '2017-08-12', 'studyFirstSubmitQcDate': '2017-09-27', 'lastUpdatePostDateStruct': {'date': '2020-03-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-10-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduction in stunting', 'timeFrame': '18 months', 'description': '10% reduction in stunting in children'}, {'measure': 'SBCC package on the basis of formative research', 'timeFrame': '3 months', 'description': 'SBCC package will be developed on the basis of formative research'}, {'measure': 'Cost-effectiveness of intervention packages for prevention of stunting in children', 'timeFrame': '18 months', 'description': 'Cost effectiveness analysis will run through the full three years of the program cost'}], 'secondaryOutcomes': [{'measure': 'Weight gain in kilograms', 'timeFrame': '18 months', 'description': 'Child weight in kilograms will be measured on monthly basis'}, {'measure': 'Length gain in centimeters', 'timeFrame': '18 months', 'description': 'Child length in centimeters will be measured on monthly basis'}, {'measure': 'Impact of the intervention on micronutrient deficiencies', 'timeFrame': 'At 24 months of age', 'description': 'Impact of the intervention on micronutrient deficiencies will be measured at 24 months by biochemical analysis'}, {'measure': 'Improvement in IYCF practices', 'timeFrame': '18 months', 'description': 'Improvement in IYCF practices will be measured from monthly follow-up data'}, {'measure': 'Improved nutrition, hygiene and health related knowledge and practices', 'timeFrame': '18 months', 'description': 'Improved nutrition, hygiene and health related knowledge and practices will be measured from endline KAP data'}, {'measure': 'Proportion of households with moderate or severe hunger (food insecurity)', 'timeFrame': '18 months', 'description': 'Food insecurity will be measured from baseline and endline data'}, {'measure': 'Uptake of health services and interventions', 'timeFrame': '18 months', 'description': 'Uptake of health services and interventions will be measured from baseline and endline data'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Specialized Nutritious Food (SNF)', 'Social and Behaviour change communication (SBCC)', 'Cash-based transfers'], 'conditions': ['Stunting']}, 'referencesModule': {'references': [{'pmid': '39575728', 'type': 'DERIVED', 'citation': 'Onah MN, Khan GN, Kureishy S, Bourdaire J, de Pee S, Garzon C, Ihtesham Y, Akbar N, Soofi SB. The cost-effectiveness of a cash-based transfer, specialised nutritious food, and social and behaviour change communication intervention package to prevent undernutrition among children 6-23 months in Pakistan: A cluster randomised controlled trial. J Glob Health. 2024 Nov 22;14:04186. doi: 10.7189/jogh.14.04186.'}, {'pmid': '34612491', 'type': 'DERIVED', 'citation': 'Soofi SB, Ariff S, Khan GN, Habib A, Kureishy S, Ihtesham Y, Hussain M, Rizvi A, Sajid M, Akbar N, Garzon C, de Pee S, Bhutta ZA. Effectiveness of unconditional cash transfers combined with lipid-based nutrient supplement and/or behavior change communication to prevent stunting among children in Pakistan: a cluster randomized controlled trial. Am J Clin Nutr. 2022 Feb 9;115(2):492-502. doi: 10.1093/ajcn/nqab341.'}, {'pmid': '32831183', 'type': 'DERIVED', 'citation': 'Khan GN, Kureishy S, Ariff S, Habib MA, Usmani AA, Mubarik A, Hussain M, Akbar N, Rodriguez de Castro P, Garzon AC, de Pee S, Soofi SB. Specialized Nutritious Food Combined With Cash Transfers and Social and Behavior Change Communication to Prevent Stunting Among Children Aged 6 to 23 Months in Pakistan: Protocol for a Cluster Randomized Controlled Trial. JMIR Res Protoc. 2020 Aug 24;9(8):e19001. doi: 10.2196/19001.'}]}, 'descriptionModule': {'briefSummary': 'Malnutrition is a public health problem, with long-lasting physiological consequences and increased risk of morbidity and mortality. It can be recognized as one of the key obstacles in national development, due to its influence on individual productivity, school performance and physical work capacity. Malnutrition is a hidden crisis in Pakistan, with rates increasing during the last decade. High prevalence of food insecurity, illiteracy, lack of nutritional knowledge, poor hygiene status, and under recognized role of nutrition are some of the possible causes. The situation of malnutrition in Pakistan necessitates an urgent need for addressing its causes through various nutrition interventions, in order to ensure a bright future for the coming generations.\n\nAlthough, malnutrition is a major problem across Pakistan, its burden and implications in the remote districts of Punjab are quite evident. The levels of undernutrition in district Rahim Yar Khan are high, with 47% of children being underweight. These numbers also highlight the presence of long-term undernutrition in the district, as evidenced by 45% of the children being stunted in 2014.\n\nGiven the alarming situation of child malnutrition in district Rahim Yar Khan, the World Food Program (WFP) Pakistan is proposing an intervention program comprised of cash-based transfers, specialized nutritious foods and behaviours change communication to prevent stunting in district Rahim Yar Khan, province Punjab. The interventions will be delivered through the existing health system and Benazir Income Support Programme (BISP). It is anticipated that the intervention will reduce the widespread macro and micro nutrient malnutrition and food insecurity in the targeted areas. Furthermore, to ensure the presence of adequate evidence to persuade policymakers for further scaling up, it is essential that an impact evaluation be conducted. Therefore, the Department of Paediatrics and Child Health, Aga Khan University (AKU) using robust methodologies on a representative sample size in the district of Rahim Yar Khan to assess the effectiveness of the WFP interventions on process and outcome indicators.', 'detailedDescription': 'Malnutrition is a public health problem, with long-lasting physiological consequences and increased risk of morbidity and mortality. It can be recognized as one of the key obstacles in national development, due to its influence on individual productivity, school performance and physical work capacity. Malnutrition is a hidden crisis in Pakistan, with rates increasing during the last decade. High prevalence of food insecurity, illiteracy, lack of nutritional knowledge, poor hygiene status, and under recognized role of nutrition are some of the possible causes. The situation of malnutrition in Pakistan necessitates an urgent need for addressing its causes through various nutrition interventions, in order to ensure a bright future for the coming generations.\n\nThe second Lancet Series on Maternal and Child Under-nutrition (2013) and the Scaling-Up Nutrition (SUN) Initiative give some recommendations on selected effective approaches for the management and prevention of under-nutrition, such as breastfeeding counselling or micronutrient supplementation, but evidence gaps still remain, particularly concerning indirect interventions. The World Health Organization highlighted in 2010 the need to consider prevention strategies when implementing programs aiming at reducing stunting rates. There is also evidence showing that preventive programs, such as supplementation, can be more effective to reduce childhood under-nutrition than nutrition rehabilitation. Reviews on cash transfer experiences show that this type of intervention has the potential to prevent undernutrition. However, most of the cash transfer programs implemented and scientifically evaluated do not have a clear nutritional objective, which leads to inconclusive evidence regarding their nutritional benefits.\n\nAlthough, malnutrition is a major problem across Pakistan, its burden and implications in the remote districts of Punjab are especially evident. The levels of undernutrition in district Rahim Yar Khan are high, with 47% of children being underweight. These numbers also highlight the presence of long-term undernutrition in the district, as evidenced by 45% of the children being stunted in 2014.\n\nGiven the alarming situation of child malnutrition in Rahim Yar Khan district, the World Food Programme (WFP) Pakistan is proposing an intervention programme comprised of cash-based transfers, specialized nutritious foods and behavior change communication to prevent stunting in Rahim Yar Khan district, Punjab province. The interventions will be delivered through the existing health system and the social protection programme, Benazir Income Support Programme (BISP). It is anticipated that the intervention will reduce the widespread macro and micro nutrient malnutrition and food insecurity in the targeted areas. Furthermore, to ensure the presence of adequate evidence to persuade policymakers for further scaling up, it is essential that an impact evaluation be conducted. The study will be conducted by the Aga Khan University (AKU) using robust methodologies on a representative sample size in the district of Rahim Yar Khan. This document will describe the methods and strategies that AKU will employ to assess the effectiveness of the interventions on process and outcome indicators.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '7 Months', 'minimumAge': '6 Months', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. BISP beneficiary for intervention arms and poverty score between 16.18 - 20.00 according to the BISP approach for control group;\n2. Living in the catchment area of LHW;\n3. Have at least one child of 6-7 months old at the time of inclusion, and;\n4. Willing and able to provide written informed consent for the study.\n\nExclusion Criteria:\n\n1. Non BISP households\n2. Planning to migrate form the study area in next 18 months\n3. Unable to provide written informed consent\n4. Children with severe malnutrition and/or chronic illness'}, 'identificationModule': {'nctId': 'NCT03299218', 'briefTitle': 'Effectiveness of SNF, Cash and BCC to Prevent Stunting Among Children 6-24 Months in Rahim Yar Khan, Pakistan', 'organization': {'class': 'OTHER', 'fullName': 'Aga Khan University'}, 'officialTitle': 'Effectiveness of a Programme Comprised of SNF, Cash-based Transfers and BCC to Prevent Stunting Among Children 6-24 Months in Rahim Yar Khan, Punjab, Pakistan', 'orgStudyIdInfo': {'id': 'CBT Study Rahim Yar Khan'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Receiving current Government of Punjab health services'}, {'type': 'EXPERIMENTAL', 'label': 'Cash-based transfers', 'description': 'Cash-based transfers only by BISP', 'interventionNames': ['Other: Cash']}, {'type': 'EXPERIMENTAL', 'label': 'Cash with SBCC', 'description': 'Cash-based transfers and Social \\& behaviour change communication (SBCC)', 'interventionNames': ['Behavioral: Social and behaviour change communication (SBCC)', 'Other: Cash']}, {'type': 'EXPERIMENTAL', 'label': 'Cash with SNF (Wawamum)', 'description': 'Cash-based transfers and SNF (Wawamum)', 'interventionNames': ['Dietary Supplement: SNF (Wawamum)', 'Other: Cash']}, {'type': 'EXPERIMENTAL', 'label': 'Cash,SNF (Wawamum) & SBCC', 'description': 'Cash-based transfers, SNF (Wawamum) and SBCC', 'interventionNames': ['Dietary Supplement: SNF (Wawamum)', 'Behavioral: Social and behaviour change communication (SBCC)', 'Other: Cash']}], 'interventions': [{'name': 'SNF (Wawamum)', 'type': 'DIETARY_SUPPLEMENT', 'description': 'A monthly ration of 30 sachets of SNF (one 50 gram sachet of Wawamum per child per day) will be provided by LHWs. Each recruited child will receive SNF on a monthly basis for the duration of 18 months during his/her age of 6-24 months.', 'armGroupLabels': ['Cash with SNF (Wawamum)', 'Cash,SNF (Wawamum) & SBCC']}, {'name': 'Social and behaviour change communication (SBCC)', 'type': 'BEHAVIORAL', 'description': 'SBCC messages will be delivered by LHWs in their monthly routine household visits. Male and female group sessions will be arranged on quarterly basis with the help of health committees.', 'armGroupLabels': ['Cash with SBCC', 'Cash,SNF (Wawamum) & SBCC']}, {'name': 'Cash', 'type': 'OTHER', 'description': 'Cash totaling 1600 rupees per month will be transferred by BISP throughout the study period.', 'armGroupLabels': ['Cash with SBCC', 'Cash with SNF (Wawamum)', 'Cash,SNF (Wawamum) & SBCC', 'Cash-based transfers']}]}, 'contactsLocationsModule': {'locations': [{'zip': '64200', 'city': 'Rahim Yar Khan', 'state': 'Punjab Province', 'country': 'Pakistan', 'facility': 'Tehsil Rahim Yar Khan', 'geoPoint': {'lat': 28.41987, 'lon': 70.30345}}], 'overallOfficials': [{'name': 'Sajid B Soofi, FCPS, MBBS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Aga Khan University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aga Khan University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Benazir Income Support Programme (BISP)', 'class': 'OTHER'}, {'name': 'Punjab Health Care Commission', 'class': 'OTHER'}, {'name': 'World Food Programme (WFP)', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Dr Sajid Bashir Soofi', 'investigatorAffiliation': 'Aga Khan University'}}}}