Worksite intervention study to prevent diabetes in Nepal: a randomised trial protocol

Abstract

IntroductionIn Nepal, approximately 31% of adult industrial employees have diabetes. While the prevention of type 2 diabetes through behavioural intervention has been disseminated, worksite could be an effective platform for the translation of this knowledge into action as employed adults spend most of their workday waking hours at workplaces.Methods and analysisWe will conduct a randomised controlled trial to assess the effectiveness of a behavioural and a canteen intervention on diabetes risk reduction among those who are prediabetic at two worksites in eastern Nepal. We will recruit 162 adult full-time factory workers with haemoglobin A1c (HbA1c) of 5.7%–6.4% at baseline or fasting blood sugar of 100–125 mg/dL. The 8–14 months’ control period will be followed by the behavioural intervention where half of the participants will be randomised to receive the behavioural intervention and half will act as a control and will not receive any intervention. Then, all participants will receive the canteen intervention. The analysis will be intent-to-treat, comparing the difference in the change in HbA1c% between the behavioural intervention group and the control group using a two-sample t-test. The within-participant changes in HbA1c after 6 or more months on the canteen intervention among those not randomised to the behavioural intervention in the previous period will be assessed using the paired t-test.Ethics and disseminationEthical approval was obtained from the Institutional Review Board at Yale School of Public Health, New Havens, USA and the Nepal Health Research Council.Trial registration numberNCT04161937.

Acceptability, Feasibility, and Effectiveness of a Worksite Intervention to Lower Cardiometabolic Risk in South Africa: Protocol

“…Pre-post measures of the following cardiometabolic risk factors will be assessed: HbA1c, blood pressure, and lipids to determine intervention impact. The South African Worksite Intervention Study is based on a global model with similar research implementation at worksites in Nepal and India [ 16 , 17 , 18 ]. The schedule of enrolment and assessment for the South African Worksite Intervention Study is presented in Table 1 .…”

“…The specific objectives of aim 3 are as follows: To measure the effectiveness of a canteen intervention on a composite score based upon improvement in cardiometabolic risk factors (2–3) with success defined by glycosylated hemoglobin (HbA1c) decrease ≥ 0.5%, a systolic blood pressure decrease ≥ 5 mmHg, and a decrease in plasma triglycerides ≥ 0.1 mmol/L [ 16 , 17 , 18 ]. We will compare the change in the participants’ score from the canteen intervention, from baseline to endline results.…”

“…We will compare the change in the participants' score from the canteen intervention, from baseline to endline results. • To measure the effectiveness of a CB intervention on a composite score based upon improvement in cardiometabolic risk factors (0-3) with success defined by HbA1c decrease ≥ 0.5%, a systolic blood pressure decrease ≥5 mm Hg, and a decrease in plasma triglycerides ≥ 0.1 mmol/L [16][17][18]. We will compare the change in the score from the CB group from baseline to endline results.…”