Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-04-05 @ 7:53 PM
Study NCT ID:
NCT07442318
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-02
First Post:
2026-01-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Enabling Environments for Non-communicable Disease Risk Reduction in Ethiopia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000073296', 'term': 'Noncommunicable Diseases'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'This is an open-label, cluster-randomized trial. Due to the ENABLE intervention being a behavioral and health systems intervention, masking of health workers is not feasible.\n\nOutcome assessment is partially blinded. Data collectors responsible for outcome measurements and independent data analysts are blinded to cluster allocation. Primary and secondary outcomes are collected using standardized data collection procedures, which minimize the risk of measurement bias, including in situations where some outcomes are recorded by health workers aware of facility allocation.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants are assigned to study arms using a parallel-group, cluster-randomized design. Urban public health centers constitute the unit of randomization. Clusters are allocated in a 1:1 ratio to either the intervention or control arm and remain in their assigned group for the duration of the study.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1268}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-02-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2027-01-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-27', 'studyFirstSubmitDate': '2026-01-27', 'studyFirstSubmitQcDate': '2026-02-27', 'lastUpdatePostDateStruct': {'date': '2026-03-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-01-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Implementation outcomes of the ENABLE Intervention', 'timeFrame': '7a-d: Two occasions, i.e., baseline, and at 12 months after facilitation has commenced 7e: 12 months after facilitation has commenced 7f: two occasions, 6 and 12 months after facilitation has commenced', 'description': 'Implementation outcomes are assessed among health workers, UHEPs and facilitators involved in delivering the ENABLE intervention. Outcomes include: a)acceptability of counselling pregnant women on NCD risk factors; b)appropriateness of counselling pregnant women on NCD risk factors; c)feasibility of counselling pregnant women on NCD risk factors; d)contextual factors that may influence the counselling pregnant women on NCD risk factors; e)experiences of of facilitators involved in supporting the ENABLE intervention. Data are collected through structured surveys and interviews.'}, {'measure': 'Use of digital ANC tool', 'timeFrame': 'At 3 months and at 9 months', 'description': 'Use of the digital antenatal care tool is assessed among health workers in intervention facilities, including frequency of use, completeness of documentation, and perceived usefulness for clinical decision-making and service delivery. Data are collected via system logs and health worker surveys.'}], 'primaryOutcomes': [{'measure': 'Birth weight', 'timeFrame': 'At delivery (within 24 hours)', 'description': 'Birth weight of the newborn measured in grams within 24 hours of delivery using calibrated scales and recorded in the routine register or digital ANC eRegistry.'}], 'secondaryOutcomes': [{'measure': 'Dietary Behavior', 'timeFrame': 'Baseline (enrollment) and third trimester of pregnancy (≥28 weeks of gestation)', 'description': 'Dietary behaviors are assessed using diet quality indicators, including dietary diversity score, minimum dietary diversity for women (MDD-W), Global Dietary Recommendation (GDR) score, NCD risk scores measured by the Diet Quality Questionnaire. In a subsample of participants selected for biomarker collection, multiple-pass 24-hour dietary recalls will be conducted to derive Global Diet Quality Score, adherence to the Ethiopian Food-Based Dietary Guidelines, and mean probability of adequacy of micronutrients based on dietary intake. In the same subsample, maternal biological samples will be collected and analyzed for selected biochemical markers of micronutrient deficiencies.'}, {'measure': 'Physical activity', 'timeFrame': 'Baseline (enrollment) and third trimester of pregnancy (≥28 weeks of gestation)', 'description': 'Physical activity is assessed using self-reported measures of frequency, duration and intensity of activities (both physical activity and sedentary activities) during pregnancy, using the Pregnancy Physical Activity Questionnaire. In a sub-sample physical activity is additionally assessed using wearable activity monitors to record movement and sedentary time.'}, {'measure': 'Air pollution exposure-related behaviors', 'timeFrame': 'Baseline (enrollment) and third trimester of pregnancy (≥28 weeks of gestation)', 'description': 'Behaviors related to air pollution exposure are assessed using a composite index capturing the adoption of recommended practices to reduce household and environmental air pollution during pregnancy. In a subsample of participants, household air quality is objectively assessed using air pollution monitoring devices to estimate indoor air pollutant levels.'}, {'measure': 'Quality of NCD counseling during ANC', 'timeFrame': 'Three occasions, i.e., baseline, and at 12 and 18 months after facilitation has commenced. The last measurement includes a 6-month follow-up after completing the facilitation component.', 'description': 'Fidelity to the delivery of the counseling on NCD risk factors during ANC and its perceived quality is assessed through structured surveys with pregnant women attending ANC services in both intervention and control facilities. Measures capture the content, frequency, and perceived quality of counseling related to diet, physical activity, and air pollution during pregnancy.'}, {'measure': 'Quality of ANC related to NCDs', 'timeFrame': 'Baseline, and at 12 months after implementation has commenced', 'description': 'Quality of ANC assessed using routine service delivery indicators reflecting appropriate screening and management of pregnancy-related conditions associated with NCD. Indicators include the proportion of pregnant women appropriately screened and managed for anemia, gestational diabetes, gestational hypertension, and maternal malnutrition, assessed using mid-upper arm circumference (MUAC) and body mass index (BMI). Data are derived from routinely collected ANC records in both intervention and control facilities.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Antenatal care', 'Pregnancy', 'Primary Health Care', 'Behavioral Counseling', 'Digital Health', 'Chronic Disease Risk Factors', 'Health Promotion', 'Dietary Behavior', 'Physical Activity', 'Air Pollution', 'Health Services Research', 'Clinical Decision Support Systems'], 'conditions': ['Non-communicable Diseases (NCD)']}, 'descriptionModule': {'briefSummary': "The ENABLE study focuses on pregnant women attending routine antenatal care (ANC) in urban primary health care facilities in four Ethiopian cities. Many women in this setting face increased health risks due to unhealthy diets, low physical activity, and exposure to air pollution which can affect both maternal and newborn health and increase the risk of non-communicable diseases (NCDs) later in life.\n\nIn this study, pregnant women in intervention health centers receive structured, tailored counseling as part of their regular ANC visits. This counseling supports healthier eating, physical activity and reduced exposure to air pollution. Health care providers, including health workers in health centers and Urban Health Extension Professionals (UHEPs), are trained to deliver this counseling supported by a digital ANC eRegistry for clinical decision-making, which enhances adherence to national guidelines, and strengthens the quality of care. Facilitators further strengthen the intervention's implementation by ensuring fidelity to counseling protocols and by adapting content to the Ethiopian urban health system context.\n\nThe study hypothesis is that integrating lifestyle counseling into routine ANC will improve maternal health behaviors and pregnancy outcomes, and reduce NCD risk among pregnant women, compared with standard routine ANC alone.\n\nBy embedding NCD prevention within routine maternal health services, the ENABLE study aims to strengthen the role of ANC as a platform for early prevention and long-term health benefits for women and their children.", 'detailedDescription': 'The ENABLE study is a two-arm, parallel-group, cluster-randomized controlled trial (cRCT) designed to address the rising burden of NCDs in Ethiopia by integrating NCD risk reduction counseling into routine ANC.\n\nThe investigators will evaluate the effectiveness and implementation of an integrated ANC-based intervention for reducing NCD risk factors during pregnancy in urban Ethiopia. The trial follows a Hybrid Type II effectiveness-implementation design, simultaneously assessing effectiveness on improving birth outcomes, specifically birth weight, and evaluating implementation processes under routine primary health care conditions.\n\nThe study will be conducted in 77 public urban health centers in four Ethiopian cities: Addis Ababa, Adama, Harar, and Jimma. Health centers and their catchment areas constitute the unit of randomization (clusters)," and are allocated in a 1:1 ratio to the intervention or control arm using covariate-constrained randomization to ensure balance by facility size and baseline ANC caseload. The trial will enroll 1,268 pregnant women (approximately 19 per cluster) who are attending their first routine ANC visit at ≤20 weeks of gestation. The women will be followed up through delivery.\n\nThe ENABLE intervention integrates structured counselling on three modifiable NCD risk factors, namely unhealthy diet, physical inactivity, and exposure to air pollution, into routine ANC services. The intervention is designed to be delivered within existing health care delivery systems by health workers and UHEPs within routine service workflows. Counseling follows the WHO 5As behavior change model (Ask, Advise, Assess, Assist, Arrange) which is based on WHO\'s brief intervention ("BRIEF project"), national ANC guidelines, and other relevant national recommendations and has been adapted to the local context.\n\nBased on previous knowledge and formative work, the intervention is implemented through three tailored implementation strategies:\n\ni) Facilitation: Trained facilitators provide ongoing support and collaborative problem-solving around intervention delivery to health workers and UHEPs to strengthen counseling skills and ensure fidelity to the intervention.\n\nii) Digital ANC eRegistry: A digital tool, adapted from the WHO Digital Adaptation Kit, supports standardized screening, clinical decision support, documentation, automates SMS reminders for patients, and routine monitoring of service quality and outcomes at the point of care.\n\niii) Training: Health workers in intervention facilities receive targeted training on NCD risk screening, counseling delivery, and use of the digital ANC eRegistry to promote sustainable integration of NCD prevention within routine maternal health services.\n\nHealth centers randomized to the control arm continue to provide standard routine ANC according to national guidelines, without access to ENABLE training, facilitation or the digital ANC eRegistry.\n\nThe primary effectiveness outcome is newborn birth weight. Other outcomes include maternal dietary quality, physical activity, behaviors related to indoor air pollution exposure, and quality of ANC service delivery and NCD-related screening and counseling practices. Implementation outcomes include feasibility, acceptability, appropriateness, fidelity, and contextual determinants of implementation. Data are collected using structured surveys, routine digital records, and qualitative methods (focus group discussions and interviews).\n\nAdditionally, a biomarker sub-study will examine early-life biological pathways associated with early NCD risks by analyzing maternal and newborn blood and urine samples from a subset of participants.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnant women aged 18 years or older\n* Gestational age ≤20 weeks at the time of enrollment\n* Residing in one of the four study cities (Addis Ababa, Adama, Harar, or Jimma)\n* Attending their first antenatal care visit at one of the participating public health facilities\n* Willing and able to provide informed consent\n\nExclusion Criteria:\n\n* Pregnant women identified as high risk at enrollment, including those with pre-existing medical conditions, or other conditions requiring specialized care and who cannot continue receiving standard routine ANC.'}, 'identificationModule': {'nctId': 'NCT07442318', 'acronym': 'ENABLE', 'briefTitle': 'Enabling Environments for Non-communicable Disease Risk Reduction in Ethiopia', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Norwegian Institute of Public Health'}, 'officialTitle': 'Enhancing Non-Communicable Disease Prevention Among Pregnant Women Through Healthy Lifestyle Promotion in Four Urban Sites in Ethiopia: A Cluster Randomized Controlled Trial in Primary Health Care Facilities', 'orgStudyIdInfo': {'id': 'EPHI-IRB-607-2025'}, 'secondaryIdInfos': [{'id': '101137232', 'type': 'OTHER_GRANT', 'domain': 'EU'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ENABLE Intervention arm', 'description': 'Pregnant women in the intervention arm receive antenatal care (ANC) at health centers implementing the ENABLE intervention. In addition to routine ANC, health workers in health centers allocated to this arm integrate structured counseling on three modifiable non-communicable disease (NCD) risk factors during pregnancy, supported by implementation strategies. Participants are followed from enrollment through delivery, with outcome data collected during routine care and scheduled study assessments.', 'interventionNames': ['Behavioral: Structured lifestyle counseling integrated into ANC']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control arm', 'description': 'Pregnant women in the control arm receive standard routine antenatal care (ANC) according to the Ethiopian national guidelines at health centers assigned to the control group. Unlike the intervention group, the control group does not receive the ENABLE multicomponent package, therefore health workers at these health centers are not provided with ENABLE facilitator-supported counseling, training or digital tools. Participants are followed from enrollment through delivery, with outcome data collected during standard routine care and scheduled study assessments.', 'interventionNames': ['Behavioral: Standard routine ANC']}], 'interventions': [{'name': 'Structured lifestyle counseling integrated into ANC', 'type': 'BEHAVIORAL', 'description': 'The intervention is delivered throughout pregnancy beginning at enrollment. The intervention is implemented through three context tailored strategies: health worker training, facilitation, and a digital ANC eRegistry.\n\nThe ENABLE intervention integrates structured counseling on three modifiable non-communicable disease (NCD) risk factors into routine antenatal care (ANC), to promote healthy dietary behaviors, physical activity, and behaviors related to exposure to air pollution during pregnancy, aiming to improve maternal and newborn outcomes.\n\nFacility and community-based health workers counsel pregnant women during scheduled ANC visits and through community outreach contacts by Urban Health Extention Proffesionals (UHEPs).', 'armGroupLabels': ['ENABLE Intervention arm']}, {'name': 'Standard routine ANC', 'type': 'BEHAVIORAL', 'description': 'Standard routine antenatal care (ANC) as defined by the Ethiopian national ANC guidelines. This includes standard clinical assessments, counseling and follow-up provided during pregnancy.', 'armGroupLabels': ['Control arm']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Masresha Tessema, PhD', 'role': 'CONTACT', 'email': 'dr.masresha.tessema@gmail.com', 'phone': '+251919782082'}, {'name': 'Jerusalem Belay, MSc', 'role': 'CONTACT', 'email': 'jerusalembelay1207@gmail.com', 'phone': '+251909647171'}], 'overallOfficials': [{'name': 'Masresha Tessema, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ethiopian Public Health Institute'}, {'name': 'Eleni Papadopoulou, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Norwegian Institute of Public Health'}]}, 'ipdSharingStatementModule': {'timeFrame': 'The anonymised IPD will be made available after completion of the primary analyses and publication of all trial results.', 'ipdSharing': 'YES', 'description': 'Fully anonymised individual participant data generated in the ENABLE trial will be made available to other researchers. Data will be de-identified prior to sharing, with all direct and indirect identifiers removed. Access to the data will be managed through the institutional data repository of the Ethiopian Public Health Institute (EPHI) following a formal application and approval process.', 'accessCriteria': "Access will be granted to qualified researchers upon request, subject to approval by EPHI and the ENABLE consortium, and in accordance with ethical approvals, data protection regulations, and the study's informed consent."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Norwegian Institute of Public Health', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Ethiopian Public Health Institute', 'class': 'OTHER_GOV'}, {'name': 'Addis Continental Institute of Public Health', 'class': 'OTHER'}, {'name': 'Jimma University', 'class': 'OTHER'}, {'name': 'Haramaya Unversity', 'class': 'OTHER'}, {'name': 'Lund University', 'class': 'OTHER'}, {'name': 'University of Oslo', 'class': 'OTHER'}, {'name': 'Uppsala University', 'class': 'OTHER'}, {'name': 'Vital Strategies', 'class': 'OTHER'}, {'name': 'Aveiro University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}