NCT04161937: WSS

Work-Site Intervention Study to Prevent Diabetes in Nepal

Status unknown NA Last updated 18 November 2019

What this trial tests

NA trial testing Behavioural Intervention in Diabetes in 163 participants. Status unknown.

Timeline

1 January 2018

Primary endpoint
1 September 2020

28 February 2021

Quick facts

Lead sponsor	B.P. Koirala Institute of Health Sciences
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	163
Start date	1 January 2018
Primary completion	1 September 2020
Estimated completion	28 February 2021
Sites	1 location across Nepal

Drugs / interventions tested

• Behavioural Intervention

Conditions studied

• Diabetes — all drugs for Diabetes →

Sponsor

B.P. Koirala Institute of Health Sciences

Who can join

Adults 18 to 100, any sex, with Diabetes. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The burden of non-communicable disease is on the rise in low- and middle- income countries.Cardiovascular disease is the leading cause of morbidity, mortality, and disability in South Asian regions. Diabetes mellitus is among the top five risk factors for cardiovascular deaths in the world.

Despite the evidence supporting the use of lifestyle interventions to prevent diabetes and improve glucose tolerance, their translation in real world has been challenging. Work-site-based health programs have shown positive impacts on employee health, and have shown significant improvements in blood glucose levels and HbA1C.

The research will be conducted in 1) Hulas wire Industry and 2) Pragati Textile Industry Private limited.

Investigator will conduct before-and-after intervention among pre-diabetic employees.In addition screening will be done to identify the eligible participants.Those who are pregnant,under diabetic and hypertensive medication will be excluded from the study. All of the interested adult employees (≥18 years) will be invited for the first screening. All individuals with HbA1C from 5.7% to 6.4 % will be invited to participate in the study. At baseline, investigators will administer a standardized questionnaire to record the characteristics of the participants.Blood samples will be collected and analyzed for HbA1c, fasting glucose, and lipid profile.

Investigators will have a wait period before implementing any intervention.After completion of control period,half of the participants will be randomized to receive behavioral interventions. Behavior intervention will comprise of combination of intensive education session, group counseling, goal setting and monitoring.Trained nurses will deliver the sessions once every week for two months and then once every month.All the participants will receive canteen intervention after behavioral intervention which will comprise of promotion of healthy foods in the canteen of the study site i.e Improve physical facility ,increase access to healthy food, Information, Education and communication, changes in food price and training of canteen staffs Investigators will conduct follow up at 6 months, 12 months, and 18 months and if funds are available at 24 months. During each follow up, the proportion of unhealthy diet consumption data will be abstracted. In addition, blood samples will be collected and analyzed for HbA1c, fasting glucose, and lipid profile .This period will serve as control group.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Worksite intervention study to prevent diabetes in Nepal: a randomised trial protocol.
   Pyakurel P, Shrestha A, Karmacharya BM, Budhathoki SS, et al · · 2020 · cited 3× · PMID 32847993 · DOI 10.1136/openhrt-2019-001236