Ignite Creation Date:
2025-12-24 @ 4:35 PM
Ignite Modification Date:
2026-02-22 @ 7:02 AM
Study NCT ID:
NCT04133766
Status:
TERMINATED
Last Update Posted:
2020-08-12
First Post:
2019-10-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Community-based Nutrition Program Effectiveness Evaluation in Afghanistan
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015362', 'term': 'Child Nutrition Disorders'}, {'id': 'D001942', 'term': 'Breast Feeding'}], 'ancestors': [{'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4076}}, 'statusModule': {'whyStopped': 'Funding for the study withdrawn by sponsor after baseline data collected', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2019-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2020-07-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-10', 'studyFirstSubmitDate': '2019-10-18', 'studyFirstSubmitQcDate': '2019-10-18', 'lastUpdatePostDateStruct': {'date': '2020-08-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of children ages 6-23 months who receive a minimum acceptable diet', 'timeFrame': '18 months', 'description': 'Proportion of children ages 6-23 months who receive a World Health Organization-defined minimum acceptable diet'}], 'secondaryOutcomes': [{'measure': 'Proportion of women who report initiating breastfeeding within one hour of delivery', 'timeFrame': '18 months', 'description': 'Initiating breastfeeding within one hour of birth will be measured by asking the women/mother if she initiated breastfeeding within one hour after the baby was delivered'}, {'measure': "Proportion of women who report exclusive breastfeeding for the first six months of a baby's life", 'timeFrame': '18 months', 'description': 'Exclusive breastfeeding is defined as giving infants only breastmilk, with no supplemental solid foods or liquids, including water. This measure is by self-reported practice from the mother and is constructed from questions about first liquids/feeds, all liquids taken prior to six months of age, and age of first solid food.'}, {'measure': 'Food Insecurity Experience Score', 'timeFrame': '18 months', 'description': "The level of household food insecurity experience, and ordinal categorical measure with values ranging from 0 to 8, as measured using the United Nation's Food and Agriculture Organization's Food Insecurity Experience Survey (FIES)."}, {'measure': 'Participation in household decision-making', 'timeFrame': '18 months', 'description': 'The role of men and women in the household in terms of primary decision maker is examined by a set of 8 items adapted from the Demographic and Health Survey. Nominal categorical items record the primary decision-maker within the household for a number of important decisions, including health care seeking behavior, major and minor household purchases, and behaviors related to nutrition such as food acquisition, preparation and consumption.'}, {'measure': 'Proportion of respondents who can name five critical times for washing hands to prevent disease transmission', 'timeFrame': '18 months', 'description': "Handwashing knowledge will be measured by asking respondents if they can name the five critical times for washing hands to prevent disease transmission. Those five times include: after using the toilet, before eating, before preparing food, before breastfeeding and after changing a baby's diaper/napkin (or cleaning the baby if a diaper/napkin isn't used)."}, {'measure': 'Proportion of households with a handwashing facilities stocked with soap', 'timeFrame': '18 months', 'description': 'Presence of a handwashing station/facility with soap within the home will be measured both through self-report and through direct observation by the data collector, if permission is given by the participant and/or head of household.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Nutrition', 'Breastfeeding', 'Handwashing', 'Food security', 'Low and Middle Income Country', 'Infant and Young Child Feeding'], 'conditions': ['Child Malnutrition', 'Breast Feeding', 'Nutrition']}, 'descriptionModule': {'briefSummary': 'The study will be a mixed methods, two-arm, cluster-randomized controlled trial. The primary aim of this evaluation is to measure the effectiveness of the Community-Based Nutrition Package intervention on child feeding practices among parents/caregivers to children 6 to 23 months of age in Afghanistan.', 'detailedDescription': 'The study will be a mixed methods, two-arm cluster-randomized controlled trial (CRT). Health facilities eligible to implement the CBNP in their catchment areas will serve as the unit of implementation and be randomly allocated to treatment or control groups. For each health facility, up to four health posts, among the 6-10 health posts typically attached to a health facility, will be randomly selected. Households in communities served by selected health posts will be mapped and a list of households with eligible participants will generated from which a random sample will be selected. Structured questionnaires will be administered to separate samples of women with children 6-23 months of age at baseline then approximately 18 months later. Semi-structured, in-depth interviews will also be conducted with a sub-set of selected women and samples of their husbands and mothers-in-law at baseline and endline.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Married adult woman (all married women are considered adults in Afghanistan, regardless of age)\n* Has a child between 6 and 23 months of age. For women with more than one living child between ages 6 and 23 months, questions will be asked regarding dietary experiences for the elder of the two. For twins or multiple order siblings, the eldest will be selected based on birth order.\n* Resident in the household\n\nExclusion criteria:\n\nNo specific exclusion criteria.'}, 'identificationModule': {'nctId': 'NCT04133766', 'briefTitle': 'Community-based Nutrition Program Effectiveness Evaluation in Afghanistan', 'organization': {'class': 'OTHER', 'fullName': 'FHI 360'}, 'officialTitle': 'Community-based Nutrition Program Effectiveness Evaluation in Afghanistan', 'orgStudyIdInfo': {'id': '1407870'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Community-Based Nutrition Package', 'description': 'The Community-Based Nutrition Package (CBNP) is a multi-level intervention that comprises: advocacy and training for government stakeholders and employees; selection and training of master trainers who then cascade the training at provincial level; and selection and training of community-level Nutrition Mobilizing Teams. The Nutrition Mobilizing Teams then organize a 2-day community mobilization session in the catchment areas of each health post to develop a community nutrition plan, which is then implemented by community health workers and two additional volunteers under the mentorship of the Nutrition Mobilizing Teams and with the support of the community members that participated in the community mobilization session.', 'interventionNames': ['Behavioral: Community Based Nutrition Package (CNBP)']}, {'type': 'NO_INTERVENTION', 'label': 'Standard of care', 'description': 'Current standard of existing community health services.'}], 'interventions': [{'name': 'Community Based Nutrition Package (CNBP)', 'type': 'BEHAVIORAL', 'description': 'The Community-Based Nutrition Package (CBNP) is a multi-level intervention that comprises: advocacy and training for government stakeholders and employees; selection and training of master trainers who then cascade the training at provincial level; and selection and training of community-level Nutrition Mobilizing Teams. The Nutrition Mobilizing Teams then organize a 2-day community mobilization session in the catchment areas of each health post to develop a community nutrition plan, which is then implemented by community health workers and two additional volunteers under the mentorship of the Nutrition Mobilizing Teams and with the support of the community members that participated in the community mobilization session.', 'armGroupLabels': ['Community-Based Nutrition Package']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ghazni', 'country': 'Afghanistan', 'facility': 'Not applicable - Community-Based', 'geoPoint': {'lat': 33.55391, 'lon': 68.42096}}, {'city': 'Herat', 'country': 'Afghanistan', 'facility': 'Not applicable - Community-Based', 'geoPoint': {'lat': 34.34817, 'lon': 62.19967}}, {'city': 'Parwan', 'country': 'Afghanistan', 'facility': 'Not applicable - Community-based', 'geoPoint': {'lat': 35.16601, 'lon': 69.00165}}], 'overallOfficials': [{'name': 'Said Iftekhar Sadaat, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ministry of Public Health, Islamic Republic of Afghanistan'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'Data will be available within 12 months of study completion', 'ipdSharing': 'YES', 'description': 'De-identified individual participant data for all primary and secondary outcome measures will be made available.', 'accessCriteria': 'Data will be made available without restriction.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'FHI 360', 'class': 'OTHER'}, 'collaborators': [{'name': 'United States Agency for International Development (USAID)', 'class': 'FED'}, {'name': 'Ministry of Public Health, Islamic Republic of Afghanistan', 'class': 'UNKNOWN'}, {'name': 'UNICEF', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}