Effect of community-based lifestyle education intervention to reduce cardiovascular diseases risk factors among vulnerable population in Dodoma city, Tanzania: a cluster randomized controlled trial study protocol

Tanzania is experiencing the rise of cardiovascular diseases (CVDs) and associated risk factors including hypertension, obesity and diabetes mellitus. Health education and healthy lifestyle promotion is an effective approach toward primary prevention of the risk factors and can be achieved through community-based intervention. The objective of this protocol is to test the effectiveness of community-based lifestyle education intervention in reducing CVDs risk factors among vulnerable population in Dodoma City. This protocol is designed as a cluster-randomized controlled trial with a quantitative approach in which participants aged from 31 years will be assigned randomly to a control or intervention group. A total of 800 participants will be recruited in the study. The study will consist of six stages (baseline, first to fourth follow-up, and end-line surveys) in 6 months for both the intervention and the control group. The intervention will be implemented twice-monthly for the first 3 months, then monthly for the last 3 months. In each stage, participants from all groups will be measured for biological and behavioral CVDs risk factors. Health education and a healthy lifestyle promotion for prevention of CVDs risk factors will be provided to the intervention group only during each stage. The main outcome measures will be changes in body weight, blood pressure, blood glucose, dietary habits, and physical exercise in the intervention compared with the control group. Independent and paired t-tests will be employed to make comparisons between and within groups. P-values of less than 0.05 will be considered statistically significant.