Cluster randomised controlled trial of behavioural intervention program: a study protocol for control of hypertension...

Control of blood pressure among hypertensives is a major challenge around the world. Interventions for improving hypertension control in India are very limited. This paper describes the protocol for a cluster randomized controlled trial of efficacy of behavioural intervention on control of hypertension among school teachers in Kerala.

A total of 92 schools are randomised to intervention and control group in Kerala. A baseline survey was conducted in all schools to assess the prevalence of hypertension and its risk factors among school teachers in Thiruvananthapuram district of Kerala state, India. Teachers in both sets of schools will receive a leaflet containing details on the importance of controlling hypertension. With the objective of improving control of hypertension, the intervention schools will additionally receive self-management education and behavioural intervention programs delivered by trained intervention managers along with measurement of weight, waist circumference and blood pressure. This intervention program will be developed based on the findings of the baseline survey and selected components of successful models of hypertension control from previous research done in similar settings. The intervention will be given for 3 months after which a post-survey will be conducted among teachers of both control and intervention schools. The primary outcome is change in control of hypertension and secondary outcome is the change in behavioural risk factors of hypertension both in the control and intervention groups.

This is the first comprehensive study looking at the efficacy of behavioural intervention on hypertension control among school teachers in Kerala, India. This study is likely to provide an upper estimate of behavioural intervention on hypertension control since teachers are reported to have one of the highest compliance rates of behavioural intervention.

This trial was prospectively registered with the Clinical Trials Registry of India [CTRI/2018/01/011402] on 18 January 2018.