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Work-Site Intervention Study to Prevent Diabetes in Nepal (WSS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04161937
Recruitment Status : Active, not recruiting
First Posted : November 13, 2019
Last Update Posted : November 18, 2019
Sponsor:
Information provided by (Responsible Party):
Dr. Prajjwal Pyakurel, B.P. Koirala Institute of Health Sciences

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.


Condition or disease Intervention/treatment Phase
Diabetes Behavioral: Behavioural Intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 163 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: We have intervention and control arm and at the same time parellel
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Work-site Intervention Study to Prevent Diabetes in Nepal
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : September 1, 2020
Estimated Study Completion Date : February 28, 2021

Arm Intervention/treatment
Experimental: Behavioural Intervention
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
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.

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




Primary Outcome Measures :
  1. HbA1C [ Time Frame: 24months ]
    The primary outcome is absolute change in HbA1c



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Diabetic - HbA1c (>=6.5%) and FBS > 126mg/dl
  2. HbA1c <5.7% and FBS <100mg/dl
  3. Taking hypertension,diabetes medication
  4. Pregnancy
  5. Temporary workers
  6. Age <18 years

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04161937


Locations
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Nepal
Hulas Wire industry Private Limited and Pragati Textile Industry Private Limited
Biratnagar, Provinve 1, Nepal, 56700
Sponsors and Collaborators
B.P. Koirala Institute of Health Sciences
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dr. Prajjwal Pyakurel, Assistant Professor, B.P. Koirala Institute of Health Sciences
ClinicalTrials.gov Identifier: NCT04161937    
Other Study ID Numbers: 35/2017
BLSCHP-1603 ( Other Grant/Funding Number: Bernard Lown Scholar for Cardiovascular Health Program )
5DP1ES02545903 ( Other Grant/Funding Number: NIH Director's Pioneer Award )
First Posted: November 13, 2019    Key Record Dates
Last Update Posted: November 18, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: We will decide later on

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. Prajjwal Pyakurel, B.P. Koirala Institute of Health Sciences:
Work-site
Diabetes
Nepal
Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases