Ignite Creation Date:
2025-12-25 @ 1:17 AM
Ignite Modification Date:
2025-12-25 @ 11:26 PM
Study NCT ID:
NCT03518593
Status:
UNKNOWN
Last Update Posted:
2018-05-08
First Post:
2018-04-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of NICHE Programme Activities in Kenya
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006130', 'term': 'Growth Disorders'}, {'id': 'D044342', 'term': 'Malnutrition'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D053446', 'term': 'CASP8 and FADD-Like Apoptosis Regulating Protein'}, {'id': 'D003376', 'term': 'Counseling'}], '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'}, {'id': 'D008605', 'term': 'Mental Health Services'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D003153', 'term': 'Community Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 800}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2017-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2018-06-26', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-04-25', 'studyFirstSubmitDate': '2018-04-25', 'studyFirstSubmitQcDate': '2018-04-25', 'lastUpdatePostDateStruct': {'date': '2018-05-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06-26', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Stunting', 'timeFrame': '8-15 months', 'description': 'HAZ (height for age z score) \\< -2 SDs of WHO median'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Growth Disorders', 'Malnutrition']}, 'descriptionModule': {'briefSummary': 'This study evaluates the impact of additional cash and nutritional counselling on nutrition outcomes in pregnant women and children up to the age of two years in CT-OVC (cash transfer- orphan and vulnerable children) households in Kitui and Machakos counties of Kenya. The control arm households will receive their normal CT-OVC cash payment and the intervention arm will receive an additional cash payment and nutritional counselling.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '23 Months', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnant women and children aged up to 23 months of age in households receiving CT-OVC cash transfers in Kitui and Machakos counties of Kenya\n\nExclusion Criteria:\n\n* not residing in CT-OVC households'}, 'identificationModule': {'nctId': 'NCT03518593', 'briefTitle': 'Evaluation of NICHE Programme Activities in Kenya', 'organization': {'class': 'INDUSTRY', 'fullName': 'Kimetrica LLC'}, 'officialTitle': 'Evaluation of NICHE (Nutritional Improvements Through Cash and Health Education) Programme Activities in Kitui and Machakos, Kenya', 'orgStudyIdInfo': {'id': 'UN-43203222'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Additional cash transfer and nutritional counselling', 'interventionNames': ['Other: Cash and counselling']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Existing cash transfer only'}], 'interventions': [{'name': 'Cash and counselling', 'type': 'OTHER', 'description': 'Additional 500 Ksh per child per month and household visits by Community health Volunteers (CHVs)', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Helen Guyatt, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kimetrica LLC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kimetrica LLC', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'UNICEF', 'class': 'OTHER'}, {'name': 'European Commission', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}