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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,268
- 试验地点
- 4
- 主要终点
- Birth weight
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
ENABLE Intervention arm
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.
干预措施: Structured lifestyle counseling integrated into ANC (Behavioral)
Control arm
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.
干预措施: Standard routine ANC (Behavioral)
结局指标
主要结局
Birth weight
时间窗: At delivery (within 24 hours)
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.
次要结局
- 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)