Ignite Creation Date:
2025-12-24 @ 7:56 PM
Ignite Modification Date:
2026-03-03 @ 9:15 PM
Study NCT ID:
NCT03140904
Status:
COMPLETED
Last Update Posted:
2020-05-12
First Post:
2017-04-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Reducing the Frequency of Follow up and Task Sharing in the Treatment of Uncomplicated Severe Acute Malnutrition
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000067011', 'term': 'Severe Acute Malnutrition'}], 'ancestors': [{'id': 'D044342', 'term': 'Malnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '1. Standard weekly visits at the outpatient therapeutic feeding center until discharge\n2. Monthly visits at the outpatient therapeutic feeding center with caregiver support for home-based surveillance, with visits scheduled at weeks 4, 8, 10 and 12 until discharge.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3945}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2020-04-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-05-11', 'studyFirstSubmitDate': '2017-04-28', 'studyFirstSubmitQcDate': '2017-05-03', 'lastUpdatePostDateStruct': {'date': '2020-05-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Nutritional recovery', 'timeFrame': 'Minimum length of stay is 8 weeks', 'description': 'Defined by being free from medical complications, MUAC \\> 125 mm, and no edema for 2 weeks if admitted with edema'}], 'secondaryOutcomes': [{'measure': 'Hospitalization', 'timeFrame': 'within 2 months', 'description': 'Hospitalization, defined as referral to inpatient care for weight/edema change, or failed appetite test, clinical complication necessitating inpatient care'}, {'measure': 'Daily weight gain (g / kg / day) among recovered children', 'timeFrame': 'within 2 months', 'description': 'difference in weight (g)'}, {'measure': 'Defaulting', 'timeFrame': 'within 2 months', 'description': '3 missed scheduled facility visits in the weekly follow-up group and 1 missed scheduled facility visit in the monthly follow-up group'}, {'measure': 'Relapse', 'timeFrame': 'Within 2 months', 'description': 'Maternal report of admission to any therapeutic feeding program'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Severe Acute Malnutrition']}, 'referencesModule': {'references': [{'pmid': '41057203', 'type': 'DERIVED', 'citation': 'Ali NB, Hitchings MD, Berthe F, Aruna P, Shehu I, Nanama S, Steve-Edemba C, Grais RF, Isanaka S. Effect of caregiver training on knowledge and confidence of at-home clinical and anthropometric surveillance of children with uncomplicated severe acute malnutrition: analysis of a cross-over cluster randomised trial in Sokoto, Nigeria. BMJ Glob Health. 2025 Oct 6;10(10):e018559. doi: 10.1136/bmjgh-2024-018559.'}, {'pmid': '36962786', 'type': 'DERIVED', 'citation': 'Menzies NA, Berthe F, Hitchings M, Aruna P, Hamza MA, Nanama S, Steve-Edemba C, Shehu I, Grais RF, Isanaka S. Cost-effectiveness of monthly follow-up for the treatment of uncomplicated severe acute malnutrition: An economic evaluation of a randomized controlled trial. PLOS Glob Public Health. 2022 Dec 9;2(12):e0001189. doi: 10.1371/journal.pgph.0001189. eCollection 2022.'}, {'pmid': '35231024', 'type': 'DERIVED', 'citation': 'Hitchings MDT, Berthe F, Aruna P, Shehu I, Hamza MA, Nanama S, Steve-Edemba C, Grais RF, Isanaka S. Effectiveness of a monthly schedule of follow-up for the treatment of uncomplicated severe acute malnutrition in Sokoto, Nigeria: A cluster randomized crossover trial. PLoS Med. 2022 Mar 1;19(3):e1003923. doi: 10.1371/journal.pmed.1003923. eCollection 2022 Mar.'}, {'pmid': '31842870', 'type': 'DERIVED', 'citation': 'Isanaka S, Hedt-Gauthier BL, Salou H, Berthe F, Grais RF, Allen BGS. Active and adaptive case finding to estimate therapeutic program coverage for severe acute malnutrition: a capture-recapture study. BMC Health Serv Res. 2019 Dec 16;19(1):967. doi: 10.1186/s12913-019-4791-9.'}]}, 'descriptionModule': {'briefSummary': 'This study will be conducted as a stratified cluster randomized trial. The unit of randomization will be the outpatient therapeutic feeding center. The 10 health centers will be stratified by size, and centers within a stratum will be randomized in a 1:1 ratio to one of two schedules of treatment: (1) standard weekly visits or (2) monthly visits with support for home-based surveillance.', 'detailedDescription': 'This study will be conducted as a stratified cluster randomized trial of a monthly schedule of follow up in the treatment of uncomplicated SAM among children aged 6 to 59 months. The unit of randomization will be the outpatient therapeutic feeding center. The 10 health centers supported by International Medical Corps UK (IMC-UK) will be stratified by size (± 1000 admissions per site per year), and centers within a stratum will be randomized in a 1:1 ratio to one of two schedules of treatment: (1) standard weekly visits or (2) monthly visits with support for home-based surveillance.\n\nDistribution of the therapeutic feeding rations, as well as medical and anthropometric surveillance, will take place on a weekly or monthly basis until discharge according to the random assignment of the site. Caregivers in the monthly visit group will receive additional instruction at admission regarding home-based MUAC measurement and clinical surveillance.\n\nRegardless of intervention assignment, all children with uncomplicated SAM will receive standard medical care on admission as per national guidelines, and a home visit 2 months following discharge from the nutritional program. Additional data collection, including coverage assessment and economic costing analysis will be used to address the secondary objectives related to the evaluation of coverage and cost-effectiveness, respectively.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '59 Weeks', 'minimumAge': '6 Weeks', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age from 6 to 59 months\n* MUAC \\< 115 mm and/or grade 1-2 edema\n* Absence of current illness requiring inpatient care\n\nExclusion Criteria:\n\n* History of allergy to peanuts\n* Any other condition in which, in the judgment of the Field Investigator, would interfere with or serves as a contraindication to protocol adherence or the ability to give informed consent'}, 'identificationModule': {'nctId': 'NCT03140904', 'briefTitle': 'Reducing the Frequency of Follow up and Task Sharing in the Treatment of Uncomplicated Severe Acute Malnutrition', 'organization': {'class': 'OTHER', 'fullName': 'Epicentre'}, 'officialTitle': 'Reducing the Frequency of Follow up and Task Sharing in the Treatment of Uncomplicated Severe Acute Malnutrition: an Evaluation of Monthly Visits and Home-based Surveillance for Access-limited and High-burden Settings', 'orgStudyIdInfo': {'id': 'Reduced follow-up'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Standard weekly visits', 'description': 'Standard weekly visits at the outpatient therapeutic feeding center until discharge', 'interventionNames': ['Other: Standard weekly visits']}, {'type': 'OTHER', 'label': 'Monthly visits', 'description': 'Monthly visits at the outpatient therapeutic feeding center with caregiver support for home-based surveillance, with visits scheduled at weeks 4, 8, 10 and 12 until discharge', 'interventionNames': ['Other: Monthly visits']}], 'interventions': [{'name': 'Standard weekly visits', 'type': 'OTHER', 'description': 'Distribution of the therapeutic feeding rations, as well as medical and anthropometric surveillance, will take place on a weekly basis at the outpatient therapeutic feeding center according to the random assignment of the site, until discharge', 'armGroupLabels': ['Standard weekly visits']}, {'name': 'Monthly visits', 'type': 'OTHER', 'description': 'Distribution of the therapeutic feeding rations, as well as medical and anthropometric surveillance, will take place on a monthly basis at the outpatient therapeutic feeding center according to the random assignment of the site, until discharge', 'armGroupLabels': ['Monthly visits']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Sokoto', 'country': 'Nigeria', 'facility': 'Sokoto State Nutrition Centre', 'geoPoint': {'lat': 13.06269, 'lon': 5.24322}}], 'overallOfficials': [{'name': 'Rebecca GRAIS', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Epicentre'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Subject to individual data sharing agreements'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Epicentre', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}