Hypertension Prevention Program, Implementation and Scale up- a Hybrid Effectiveness Implementation Study in Schools of Dhulikhel and Banepa

Hypertension is a serious medical condition and can increase the risk of heart, brain, kidney and other diseases. It is a major cause of premature death worldwide, with upwards of 1 in 4 men and 1 in 5 women - over a billion people - having the condition. The burden of hypertension is felt disproportionately in low- and middle-income countries, where two-thirds of cases are found, largely due to increased risk factors in those populations in recent decades Pre-hypertension, defined as systolic blood pressure (BP) of 120-139 mmHg or diastolic BP of 80-89 mmHg, is a precursor to hypertension, and is associated with excess morbidity and deaths from cardiovascular diseases (CVD). Hence, the reduction of BP to optimal levels is a major public health priority. Although clinical trials have shown that pharmacotherapy lowers BP among pre-hypertensives; it has been argued that pharmacotherapy is not reasonable because the absolute risk in patients without other CVD risk factors is low and pharmacotherapy is costly. Lifestyle modifications have proven to reduce BP, and are also useful to prevent other chronic diseases. Major lifestyle modifications shown to lower BP include weight loss; reduced sodium intake; regular aerobic physical activity; moderate alcohol drinking; the Dietary Approach to Stop Hypertension diet - a diet rich in fruits, vegetables, low-fat dairy products, potassium and calcium, and reduced dietary cholesterol, saturated and total fats. Combinations of two or more lifestyle modifications may have even better results. However, most of the studies have focused on one or two lifestyle interventions and are tested in efficacy trials in a clinical setting. Therefore, there is a major gap in the evidence for the effectiveness of a community-based multi-component intervention on BP reduction. In addition, it is not clear how such an intervention would be scaled up to the general population in low-and-middle-income countries, where the burden of hypertension and CVD is the highest.

To address this gap, the investigators propose to conduct an effectiveness-implementation study to assess the effectiveness of a peer-led multi-component lifestyle program that will aim to lower BP among pre-hypertensive individuals in Nepal. The program will aim to encourage weight loss, improve diet (using a DASH diet), lower sodium intake, encourage only moderate alcohol intake among drinkers, and encourage more physical activity through peers. Peer education can be as effective as using health professionals and is a cost-effective and sustainable method for lifestyle modification. The peer-education approach is driven by social learning theory, emphasizing credibility, role modeling, empowerment, and reinforcement which contrasts with the delivery of lifestyle modification advice in the usual clinical setting. While implementing the peer-led multi-component lifestyle intervention, the investigators will collect information on factors affecting the delivery of the program and the potential for scaled-up implementation in a real-world situation. The feasibility and scalability of such programs in a real-life setting have not been studied. Besides, there are three key challenges to manage pre-hypertension and hypertension in low-and middle-income countries (LMICs). First, the pre-hypertensive population is considered non-diseased; hence they are not in contact with the health system. Second, even though the efficacy of lifestyle modifications has been proven, sustainable lifestyle modifications in the general population are difficult to achieve due to the complexity of behavioral change. And third, the health system in LMICs is already worn out due to the double burden of disease, and inadequate financing and human resources. To address this massive challenge in an LMIC such as Nepal, a cost-effective, community-based, sustainable, and scalable intervention is required. The proposed study will establish evidence for a new model to lower BP in a community setting, by determining the effectiveness of the peer-led multi-component program and informing the success of implementation and scalability. This model will provide a valuable resource for making recommendations and dissemination plans to implement and sustain lifestyle interventions for lowering BP at the community level.

As such, the objectives of this study are:

1. To measure the effectiveness of the peer-led online multi-component lifestyle program on reducing BP among the school employees of Dhulikhel and Banepa, Nepal. The investigators will compare the change in systolic BP at twelve months between the peer-led multi-component program group and usual care group using a community-based cluster randomized control trial.
2. To measure the success of implementation and inform the scalability of the peer-led multi-component lifestyle program. The investigators will evaluate (a) program adoption by assessing changes in weight, diet, and physical activity behaviors among lifestyle intervention participants; (b) fidelity to the program design by assessing activities of peer-educators; and (c) acceptability of the program through (i) in-depth, semi-structured interviews with lifestyle intervention program dropouts; and (ii) focus group discussions with lifestyle intervention program participants.
3. To assess the impact of Covid-19 in hypertension management in context to the mental wellbeing of hypertensive patients. The investigators will measure the impact of Covid-19 on the mental health of a participant by measuring their anxiety and depression levels through a questionnaire scale.

After identification of possible participants, the principal investigator and/or the research assistants would make formal phone calls to the principals of the different educational institutes to describe the research project. The principals of the educational institutes are, then, sent information sheets and other informational materials regarding the project via email. Then, after the approval of the principal, all the staff of the educational institutions would be sent an information sheet and other information regarding the project. After everyone is informed, a formal zoom or google meet appointment would be made with all the staff of the educational institute. In this manner, the study participants would be recruited and screened.