Enabling Environments for Non-communicable Disease Risk Reduction in Ethiopia

NCT07442318 | Recruiting DMC

• 2 other identifiers: EPHI-IRB-607-2025101137232
• Study Type: interventional
• Target: 1,268
• Locations: 1 country
• Sites: 4

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.

Conditions

Non-communicable Diseases (NCD)

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

Outcome Measures

Primary Outcomes (1)

• Birth weight

  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.

  At delivery (within 24 hours)

Secondary Outcomes (5)

• Dietary Behavior

  Baseline (enrollment) and third trimester of pregnancy (≥28 weeks of gestation)

• Physical activity

  Baseline (enrollment) and third trimester of pregnancy (≥28 weeks of gestation)

• Air pollution exposure-related behaviors

  Baseline (enrollment) and third trimester of pregnancy (≥28 weeks of gestation)

• Quality of NCD counseling during ANC

  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.

• Quality of ANC related to NCDs

  Baseline, and at 12 months after implementation has commenced

Other Outcomes (2)

• Implementation outcomes of the ENABLE Intervention

  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

• Use of digital ANC tool

  At 3 months and at 9 months

Study Arms (2)

ENABLE Intervention arm

EXPERIMENTAL

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.

Behavioral: Structured lifestyle counseling integrated into ANC

Control arm

ACTIVE COMPARATOR

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.

Behavioral: Standard routine ANC

Interventions

Structured lifestyle counseling integrated into ANC BEHAVIORAL

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).

ENABLE Intervention arm

Standard routine ANC BEHAVIORAL

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.

Control arm

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pregnant women aged 18 years or older
• Gestational age ≤20 weeks at the time of enrollment
• Residing in one of the four study cities (Addis Ababa, Adama, Harar, or Jimma)
• Attending their first antenatal care visit at one of the participating public health facilities
• Willing and able to provide informed consent

You may not qualify if:

• 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.

Sponsors & Collaborators

• Norwegian Institute of Public Health: lead
• Addis Continental Institute of Public Health: collaborator
• University of Oslo: collaborator
• Uppsala University: collaborator
• Aveiro University: collaborator
• Ethiopian Public Health Institute: collaborator
• Jimma University: collaborator
• Haramaya Unversity: collaborator
• Lund University: collaborator
• Vital Strategies: collaborator

Study Sites (4)

Addis Ababa

Addis Ababa, Addis Ababa, Ethiopia

RECRUITING

Harar

Harar, Harare, Ethiopia

RECRUITING

Adama

Ādama, Oromiya, Ethiopia

RECRUITING

Jimma

Jimma, Oromiya, Ethiopia

RECRUITING

MeSH Terms

Conditions

Noncommunicable Diseases; Motor Activity

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Masresha Tessema, PhD

  Ethiopian Public Health Institute

  PRINCIPAL INVESTIGATOR

• Eleni Papadopoulou, PhD

  Norwegian Institute of Public Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Masresha Tessema, PhD

CONTACT

+251919782082; dr.masresha.tessema@gmail.com

Jerusalem Belay, MSc

CONTACT

+251909647171; jerusalembelay1207@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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. Outcome 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 27, 2026
• First Posted: March 2, 2026
• Study Start: May 11, 2026
• Primary Completion (Estimated): April 10, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: May 28, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Time Frame: The anonymised IPD will be made available after completion of the primary analyses and publication of all trial results.
• Access Criteria: 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.

Locations

ET (4)