Enabling Environments for Non-communicable Disease Risk Reduction in Ethiopia

NCT07442318 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1268

Last updated 2026-05-22

No results posted yet for this study

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.

Conditions

  • Non-communicable Diseases (NCD)

Interventions

BEHAVIORAL

Structured lifestyle counseling integrated into ANC

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. The 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. Facility and community-based health workers counsel pregnant women during scheduled ANC visits and through community outreach contacts by Urban Health Extention Proffesionals (UHEPs).

BEHAVIORAL

Standard routine ANC

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.

Sponsors & Collaborators

  • Ethiopian Public Health Institute

    collaborator OTHER_GOV
  • Addis Continental Institute of Public Health

    collaborator OTHER
  • Jimma University

    collaborator OTHER
  • Haramaya Unversity

    collaborator OTHER
  • Lund University

    collaborator OTHER
  • University of Oslo

    collaborator OTHER
  • Uppsala University

    collaborator OTHER
  • Vital Strategies

    collaborator OTHER
  • Aveiro University

    collaborator OTHER
  • Norwegian Institute of Public Health

    lead OTHER_GOV

Principal Investigators

  • Masresha Tessema, PhD · Ethiopian Public Health Institute

  • Eleni Papadopoulou, PhD · Norwegian Institute of Public Health

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-05-11
Primary Completion
2027-04-10
Completion
2027-05-31

Countries

  • Ethiopia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07442318 on ClinicalTrials.gov