Work-Site Intervention Study to Prevent Diabetes in Nepal

NCT04161937 | Unknown DMC

• 3 other identifiers: 35/2017BLSCHP-16035DP1ES02545903
• Study Type: interventional
• Target: 163
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Work-site; Diabetes; Nepal

Outcome Measures

Primary Outcomes (1)

• HbA1C

  The primary outcome is absolute change in HbA1c

  24months

Study Arms (2)

Behavioural Intervention

EXPERIMENTAL

Half of the randomly selected participants will get behavioural intervention based on Diabetes Prevention Program module.The behavioural intervention classed will be administered by trained nurse weekly for 16 weeks.After completion of behavioural intervention both the experimental and control arm will get cafeteria intervention.

Behavioral: Behavioural Intervention

Control

EXPERIMENTAL

Half of the participants will act as a control and will not receive any form of behavioural intervention.

Behavioral: Behavioural Intervention

Interventions

Behavioural Intervention BEHAVIORAL

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.

Behavioural Intervention; Control

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) Pre-diabetic participants (HbA1c 5.7-6.4%) and FBS (\>=100 to 125mg/dl)

You may not qualify if:

• Diabetic - HbA1c (\>=6.5%) and FBS \> 126mg/dl
• HbA1c \<5.7% and FBS \<100mg/dl
• Taking hypertension,diabetes medication
• Pregnancy
• Temporary workers
• Age \<18 years

Sponsors & Collaborators

• B.P. Koirala Institute of Health Sciences: lead

Study Sites (1)

Hulas Wire industry Private Limited and Pragati Textile Industry Private Limited

Biratnagar, Provinve 1, 56700, Nepal

Location

Related Publications (1)

• Pyakurel P, Shrestha A, Karmacharya BM, Budhathoki SS, Chaudhari RK, Tamrakar D, Shrestha A, Karmacharya RM, Shrestha A, Sharma S, Sharma SK, Spiegelman D. Worksite intervention study to prevent diabetes in Nepal: a randomised trial protocol. Open Heart. 2020 Aug;7(2):e001236. doi: 10.1136/openhrt-2019-001236.

  PMID: 32847993 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: We have intervention and control arm and at the same time parellel

Study Record Dates

• First Submitted: November 10, 2019
• First Posted: November 13, 2019
• Study Start: January 1, 2018
• Primary Completion: September 1, 2020
• Study Completion: February 28, 2021
• Last Updated: November 18, 2019

Record last verified: 2019-11

Locations

NE (1)