Ignite Creation Date:
2025-12-24 @ 12:03 PM
Ignite Modification Date:
2025-12-27 @ 10:08 PM
Study NCT ID:
NCT06927661
Status:
RECRUITING
Last Update Posted:
2025-06-04
First Post:
2025-04-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ENSAND 2.0 Evaluation in Nigeria
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D014675', 'term': 'Vegetables'}], 'ancestors': [{'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': "This evaluation will use a quasi-experimental design to assess the impact of GAIN's ENSAND 2.0 program on the quantity and diversity of vegetables consumed by smallholder farmers and neighbor households. Smallholder farmers and neighbor households will be randomly selected lists of paired farmers and neighbors compiled by GAIN in 84program LGAs (2 in Kano, 2 in Kaduna). The household-level impacts of the intervention will be assessed through panel surveys in intervention LGAs at baseline and endline."}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1568}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-05-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-30', 'studyFirstSubmitDate': '2025-04-07', 'studyFirstSubmitQcDate': '2025-04-07', 'lastUpdatePostDateStruct': {'date': '2025-06-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quantity of vegetables consumed', 'timeFrame': 'Baseline (April 2025), Endline (April 2026) (1 year)', 'description': 'Change in the mean grams of vegetables consumed in the previous 24 hours by farmer and neighbor households'}, {'measure': 'Variety of vegetables consumed', 'timeFrame': 'Baseline (April 2025), Endline (April 2026) (1 year)', 'description': 'Change in the number of types of vegetables consumed by farmer and neighbor households'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['diet', 'vegetables', 'Nigeria', 'demand generation intervention', 'agricultural production intervention'], 'conditions': ['Quantity and Variety of Vegetables Consumed']}, 'descriptionModule': {'briefSummary': "The Enhancing Access to Safe and Nutritious Diets 2.0 (ENSAND) (2024-2026) project is designed to address the low per capita consumption of vegetables and variety of vegetable consumption in northern Nigeria by working with smallholder farmers to increase production and promoting healthier diets through greater vegetable consumption among farmers and their neighbors. The objective of this evaluation is to assess the effectiveness of GAIN's ENSAND program for increasing the quantity and variety of vegetables consumed by smallholder farmer households participating in the program and neighbor households paired with the farmers. This evaluation will use a quasi-experimental design to assess the impact of GAIN's ENSAND programs on the quantity and diversity of vegetables consumed by smallholder farmers and their neighbors. The evaluation will be guided by the RE-AIM (reach, effectiveness, adoption, implementation, maintenance) framework. RE-AIM is a framework that is useful for evaluating the program impact of multifaceted and multilevel interventions."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Farmer household or neighbor household recruited by ENSAND farmer\n* Located within an intervention LGA\n* Farmer must be member who is participating in the ENSAND project\n* Adult who is ≥ 18 years old\n* Able to speak English or Hausa\n* Provide informed consent to participate in the study'}, 'identificationModule': {'nctId': 'NCT06927661', 'briefTitle': 'ENSAND 2.0 Evaluation in Nigeria', 'organization': {'class': 'OTHER', 'fullName': 'RTI International'}, 'officialTitle': 'Evaluation of the Global Alliance for Improved Nutrition (GAIN) the Enhancing Access to Safe and Nutritious Diets (ENSAND) 2.0 Project in Nigeria', 'orgStudyIdInfo': {'id': '424606'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Intervention', 'interventionNames': ['Behavioral: Consumption of vegetables']}], 'interventions': [{'name': 'Consumption of vegetables', 'type': 'BEHAVIORAL', 'description': 'ENSAND 2.0 is designed to address challenges of low consumption of vegetables in both variety and quantity by working with smallholder farmers to increase production and promoting healthier diets through greater vegetable consumption. The project will build the capacity of smallholder farmers in vegetable production through collaborating with lead farmers to establish demonstration plots that showcase advanced agricultural techniques and technologies. These plots will serve as training hubs for other farmers in vegetable production, postharvest handling, as well as business and market planning. ENSAND aims to increase consumption among neighbors of the smallholder farmers by asking the farmers to recruit at least one neighbor family to whom they will regularly sell vegetables.', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Abuja', 'status': 'RECRUITING', 'country': 'Nigeria', 'contacts': [{'name': 'Abiodun F. Ipadeola, PhD', 'role': 'CONTACT', 'email': 'Abiodun.ipadeola@datametricsnigeria.com', 'phone': '+234 806 447 0614'}, {'name': 'Abiodun F. Ipadeola, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Valerie Flax, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Datametrics Associates Ltd.', 'geoPoint': {'lat': 9.05785, 'lon': 7.49508}}], 'centralContacts': [{'name': 'Valerie Flax, PhD, MPH', 'role': 'CONTACT', 'email': 'vflax@rti.org', 'phone': '(919) 541-6000'}], 'overallOfficials': [{'name': 'Abiodun F. Ipadeola, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Datametrics Associates Ltd'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Dataset will be shared through Nesstar.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'RTI International', 'class': 'OTHER'}, 'collaborators': [{'name': 'Datametrics Associates Ltd', 'class': 'UNKNOWN'}, {'name': 'University of Nigeria Nsukka', 'class': 'OTHER'}, {'name': 'University of Abuja', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior Research Public Health Analyst', 'investigatorFullName': 'Valerie Flax', 'investigatorAffiliation': 'RTI International'}}}}