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:
Norwegian Institute of Public Health
Organization:
Study Overview
Official Title:
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2026-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ENABLE
Brief Summary:
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.
In 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.
The 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.
By 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.
In 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.
The 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.
By 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.
Detailed Description:
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.
The 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.
The 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.
The 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.
Based on previous knowledge and formative work, the intervention is implemented through three tailored implementation strategies:
i) 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.
ii) 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.
iii) 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.
Health 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.
The 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).
Additionally, 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.
The 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.
The 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.
The 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.
Based on previous knowledge and formative work, the intervention is implemented through three tailored implementation strategies:
i) 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.
ii) 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.
iii) 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.
Health 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.
The 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).
Additionally, 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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 101137232 | OTHER_GRANT | EU | View |