Enabling Environments for Non-communicable Disease Risk Reduction in Ethiopia

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorNorwegian Institute of Public Health

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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).

  • 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.

Treatment groups

1,268 Participants
are divided into 2 treatment groups
Group A: ENABLE Intervention armExperimental treatment 1 intervention
Group B: Control armActive comparator 1 intervention

Trial outcomes

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.

Time frame
At delivery (within 24 hours)

Secondary outcomes

1

Dietary Behavior

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.

Time frame
Baseline (enrollment) and third trimester of pregnancy (≥28 weeks of gestation)
2

Physical activity

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.

Time frame
Baseline (enrollment) and third trimester of pregnancy (≥28 weeks of gestation)
3

Air pollution exposure-related behaviors

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.

Time frame
Baseline (enrollment) and third trimester of pregnancy (≥28 weeks of gestation)
4

Quality of NCD counseling during ANC

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.

Time frame
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.

Other outcomes

1

Implementation outcomes of the ENABLE Intervention

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.

Time frame
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
2

Use of digital ANC tool

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.

Time frame
At 3 months and at 9 months

Sponsors and contacts

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Norwegian Institute of Public Health

Lead sponsor

Ethiopian Public Health Institute

Collaborator

Addis Continental Institute of Public Health

Collaborator

Jimma University

Collaborator

Haramaya Unversity

Collaborator

Lund University

Collaborator

University of Oslo

Collaborator

Uppsala University

Collaborator

Vital Strategies

Collaborator

Aveiro University

Collaborator