Work-Site Intervention Study to Prevent Diabetes in Nepal

Summary

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.

Conditions

• Diabetes

Interventions

BEHAVIORAL

Behavioural Intervention

Behavior intervention will comprise of combination of intensive education session, group counseling, goal setting and monitoring based on the Diabetes Prevention Program (DPP).The curriculum includes 24 sessions: 16 core sessions weekly during the first four months of the program followed by a monthly maintenance sessions.

Sponsors & Collaborators

• B.P. Koirala Institute of Health Sciences

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

100 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2018-01-01

Primary Completion

2020-09-01

Completion

2021-02-28

Countries

• Nepal

Study Locations