The effectiveness, feasibility, and acceptability of an education intervention promoting healthy lifestyle to reduce risk factors for metabolic syndrome, among office workers in Ethiopia: A protocol for a randomized control trial study

Background: Nowadays, metabolic syndrome has become a major health threat, and affects over one billion people globally. It also plays a great role in the growth of diseases like type 2 diabetes, coronary diseases, stroke, and other chronicity. It increases the risk of cardiovascular disorder and stroke by three to ten times and diabetic mellitus by ten times. The prevalence of metabolic syndrome is increasing globally as a result of epidemiological shift. Low and middle-income countries are facing an increasing burden of metabolic syndrome. There is a need for concerted efforts to modify behavioral risk factors that significantly contribute to the prevalence of the syndrome. This can be done by developing and implementing appropriate interventions that can bring behavior change after testing for effectiveness, feasibility, and acceptability. Thus, this study aims to develop and test the effectiveness, feasibility and acceptability of an education intervention promoting healthy lifestyle to reduce risk factors for metabolic syndrome, among office workers in Ethiopia. 

Methods and analysis: This randomized controlled trial will be implemented with 226 bank employees (age ≥18 years) with metabolic syndrome from government and private banks in Bahir Dar City, Ethiopia. Participants will be randomized to intervention (education) and control (general health advice) groups. The intervention group will be given one-on -one base education about healthy diets, physical exercise, stress management, avoidance of harmful alcohol consumption and smoking cessation by experts on health promotion. Text messages will be sent every two weeks and reading materials will also be provided. Additionally, a review meeting will be held at the 3^rd and 6^th month of the intervention. The primary outcomes of interest will be change in metabolic parameters (obesity levels, blood pressure, fasting blood glucose, total cholesterol, high density lipoprotein, low density lipoprotein, and triglycerides). Secondary outcomes will be knowledge, attitudes and practice of the participants towards lifestyle and cardiovascular risk factors, feasibility, acceptability, implementation fidelity, and cost-effectiveness of the intervention. Data will be collected at three time points: at baseline, at the 6^th month of the intervention and at the end of the intervention (9 months). Generalized linear mixed models will be utilized to compare the desired outcome between the trial arms, after accounting for baseline variations. Cost-benefit analysis and a qualitative process evaluation of the intervention will also be conducted. 

Discussion: This randomized control trial study will provide information on the effectiveness, feasibility, and acceptability of an education intervention promoting healthy lifestyle to reduce risk factors for metabolic syndrome, among office workers in Ethiopia, where the burden of metabolic syndrome is high among office workers. 

Clinical trial registration: This trial has been prospectively registered at the Australian New Zealand Clinical Trials Registry: ACTRN12623000409673p.