Abstract
BackgroundTo increase cardiovascular disease prevention efforts, worksite interventions can promote healthy food choices, facilitate health education, increase physical activity and provide social support. This pioneer study will measure the effectiveness of a cafeteria and a behavioral intervention on cardio-metabolic risk in a worksite in Nepal.MethodsThe Nepal Pioneer Worksite Intervention Study is a two-step intervention study conducted in Dhulikhel Hospital in eastern Nepal. In the first step, we will assess the effectiveness of a 6-month cafeteria intervention on cardio-metabolic risk using a pre-post design. In the second step, we will conduct a 6-month, open-masked, two-arm randomized trial by allocating half of the participants to an individual behavioral intervention based on the ‘diabetes prevention program’ for the prevention of cardio-metabolic risk. We will recruit 366 full time employees with elevated blood pressure, fasting blood sugar, or glycosylated haemoglobin (HbA1c). At baseline, we will measure their demographic variables, lifestyle factors, anthropometry, fasting blood sugar, HbA1c,and lipid profiles. We will measure cardio-metabolic outcomes at 6 months, 12 months, and 18 months.At 12 months, we will compare the proportion of participants who have attained two or more cardio-metabolic risk factor reduction goals (HbA1c decrease ≥0.5%; systolic blood pressure decrease ≥5 mmHg; or triglycerides decrease ≥10 mg/dL) during the cafeteria intervention period and the control period using generalized estimating equations. At 18 months, we will compare the proportion from the ‘cafeteria only arm’ to the ‘cafeteria and behavior arm’ for the same outcome using a chi-square test.DiscussionThis pioneer study will estimate the effect of environmental-level changes on lowering cardio-metabolic risks; and added benefit of an individual-level dietary intervention. If the study demonstrates a significant effect, a scaled up approach could produce an important reduction in cardiovascular disease burden through environmental and individual level prevention programs in Nepal and similar worksites worldwide.Trial registrationThe trial was retrospectively registered on clincaltrials.gov (Identification Member: NCT03447340; Date of Registration: February 27, 2018).
Highlights
To increase cardiovascular disease prevention efforts, worksite interventions can promote healthy food choices, facilitate health education, increase physical activity and provide social support
In the secondary analysis, where we will compare the within-participant changes in Glycated Hemoglobin (HbA1c), systolic and diastolic blood pressure, and lipids observed in the cafeteria intervention to those observed in the behavioral intervention
We propose to implement and test a worksite-based lifestyle intervention program focusing on dietary improvement at the environmental and individual level in a hospital in Nepal
Summary
Study design The Nepal Pioneer Worksite Intervention Study is a two stage intervention study. Participants will be scored on the number of improved risk factors (0–3) as defined by decreases in (1) HbA1c ≥0.5%; (2) systolic blood pressure ≥ 5 mmHg; or (3) plasma triglycerides ≥10 mg/dl. Our secondary analysis will compare the change in HbA1c, systolic blood pressure, and lipids during the cafeteria-only intervention to the change during the control period using a paired t-test. Sample size and power The pre-post design, with at least 366 eligible and enrolled participants [28] and 5% loss to follow-up (LTF) after 12 months, will have over 90% of power to detect the primary effectiveness endpoint of this trial, of 31.5% or greater, compared to the 21% change in the control group seem previously in a South Asian population [29]. In the secondary analysis, where we will compare the within-participant changes in HbA1c, systolic and diastolic blood pressure, and lipids observed in the cafeteria intervention to those observed in the behavioral intervention.
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Free) 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
