JMIR Publications

ABSTRACT

Background:

Ethiopia faces a growing burden of preventable noncommunicable disease (NCD) risk factors, including unhealthy diets, physical inactivity, and exposure to air pollution, with women and urban populations particularly affected. Pregnancy and antenatal care (ANC) provide an opportunity to promote healthy behaviors and reduce exposure to NCD risk factors through interventions integrated into routine health services.

Objective:

The “Enabling Environments for Noncommunicable Disease Risk Reduction in Ethiopia (ENABLE)” study aims to evaluate the effectiveness and implementation of integrating NCD risk factor assessment, behavioral counseling, and follow-up support into routine ANC in urban primary health care in Ethiopia.

Methods:

ENABLE is a multisite, 2-arm, parallel-group, pragmatic cluster randomized hybrid type II effectiveness-implementation trial. Seventy-seven public health centers in Addis Ababa, Adama, Harar, and Jimma are allocated approximately 1:1 to the ENABLE intervention or routine ANC. Pregnant women aged ≥18 years attending ANC at ≤20 weeks’ gestation are recruited, with a target of 18 women per health center. Women attending intervention health centers receive routine ANC supplemented by structured assessment and counseling addressing healthy diets, physical activity, and exposure to household air pollution. The intervention is delivered by trained ANC providers at health facilities and supported at the community level by urban health extension professionals. Implementation is supported through provider training, local facilitation, and digital tools integrated into ANC delivery. Women attending control health centers receive routine ANC according to national guidelines. The primary effectiveness outcome is birth weight. Secondary outcomes include maternal behaviors and exposure to NCD risk factors, quality of ANC, and maternal and neonatal health outcomes. Data are collected at enrollment, during the third trimester, and at birth using participant surveys and routine health records. A substudy involving biological sample collection and a more detailed assessment of NCD risk factors is conducted among a subsample of participants. Acceptability, appropriateness, fidelity, and contextual influences on implementation are assessed using quantitative and qualitative methods. A prospective economic evaluation will assess intervention costs, cost-effectiveness, and budget impact.

Results:

The trial was registered at ClinicalTrials.gov (NCT07442318). Recruitment commenced in May 2026 and was completed in September 2026. A total of 76 health centers and 1378 pregnant women were included. Follow-up through the third trimester and birth is expected to be completed approximately in February 2027. As of the time of protocol submission, no comparative analyses of the primary or secondary effectiveness outcomes had been conducted.

Conclusions:

ENABLE will generate evidence on the effectiveness, implementation, and economic implications of integrating NCD risk reduction into routine ANC in urban Ethiopia. The findings will inform decisions concerning further adaptation and potential scale-up of the intervention within primary health care services. Clinical Trial: ClinicalTrials.gov NCT07442318 registered on March 2nd, 2026