Abstract
Globally, non-communicable diseases (NCDs) are a major public health concern, and in Sri Lanka they account for 84% of all deaths, highlighting their critical impact on population health. Despite the availability of Healthy Lifestyle Centers (HLCs) for NCD screening and education, uptake remains at 2.9% nationally and 6.8% in the Bellana Primary Medical Care Unit (PMCU) area, which is far below the national target of 40%. Therefore, there is an urgent need for effective, deployable, community-driven strategies to increase screening participation to early detection of NCDs.
This randomized controlled trial (RCT) aims to assess the effectiveness of educational interventions in enhancing NCD-related knowledge, modifying health beliefs and increasing screening uptake among adults aged 35–65 years residing in the Bellana PMCU catchment area of the Kalutara District, Sri Lanka. The study will be conducted from August 2025 to February 2026. A total of 450 participants will be enrolled and randomized equally into three groups (n=150 per group). The primary outcome is NCD screening uptake; secondary outcomes include changes in knowledge and health beliefs. Intervention Group 1 (T1, n=150) will receive a structured awareness session on NCD risk factors, symptoms, prevention, and services of HLC, followed by a group discussion and an educational leaflet. Intervention Group 2 (T2, n=150) will receive the same awareness session and a group discussion. The control group will participate in a placebo session on awareness of child abuse and a group discussion (n = 150). The self-administered questionnaire will include demographic information, NCD knowledge (10 items), and health beliefs based on the Health Belief Model (HBM) (24 items). The Content Validity Index (CVI) will be assessed by four experts, each with over ten years of experience in NCD control, with a target value above 0.90. Internal consistency will be assessed in a pilot study with 30 participants, with reliability coefficients expected to exceed 0.7.
Data will be collected immediately before and after the intervention using the validated questionnaire, with follow-up assessments will be conducted at two and three months after interventions to confirm increased NCD screening uptake by reviewing the Participants’ Register at PMCU Bellana. Data will be cleaned and analyzed using R (version 4.5.1) software. Analyses will follow the intention-to-treat principle, with per-protocol analyses conducted for sensitivity. Baseline characteristics will be summarized using descriptive statistics, and group differences will be evaluated using Chi-square tests for categorical variables and t-tests or Analysis of Variance (ANOVA) for continuous variables, depending on data distribution. Changes in knowledge and health belief scores will be analyzed using paired t-tests, ANOVA, and post-hoc comparisons, while screening uptake will be compared using Chi-square tests and risk ratios. To examine the underlying mechanisms, causal mediation analysis will be performed using logistic regression-based models. Missing data will be examined through sensitivity analyses, with statistical significance set at p < 0.05.
To date, no RCT in Sri Lanka has evaluated community-based educational interventions, such as awareness sessions, group discussions, and educational leaflets, within an HBM-based framework. Ethics approval will be obtained from the Ethics Review Committee of the National Institute of Health Sciences, Kalutara and Hiroshima University, prior to implementation. Written informed consent will be obtained from all eligible participants, and confidentiality will be strictly maintained. The interventions are designed to be non-invasive and culturally appropriate, with the potential to inform optimization of HLCs, support Sustainable Development Goal (SDG) target 3.4 on reducing premature mortality from NCDs, and provide a replicable model for other low- and middle-income countries (LMICs).