DiabetesWSSNCT04161937
Work-Site Intervention Study to Prevent Diabetes in Nepal
A study testing Behavioural Intervention in people with Diabetes, run by B.P. Koirala Institute of Health Sciences at 1 site in Nepal.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes
- What is being tested?
- Behavioural Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 163 participants
- Where
- 1 siteNepal
- Study dates
- 1 Jan 2018to 28 Feb 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1) Pre-diabetic participants (HbA1c 5.7-6.4%) and FBS (>=100 to 125mg/dl)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Nepal1 site
Hulas Wire industry Private Limited and Pragati Textile Industry Private Limited
Biratnagar, Provinve 1, 56700
About this study
Official title: Work-site Intervention Study to Prevent Diabetes in Nepal
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.
Read more
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.
Read the detailed description
Diabetes is the fifth leading cause of death in the most high-income countries and there is substantial evidence that it is epidemic in many low- and middle-income countries. Complications from diabetes, such as coronary artery and peripheral vascular disease, stroke, diabetic neuropathy, amputations, renal failure and blindness results in disability, reduced life expectancy and enormous health costs.The global age standardized prevalence of diabetes has nearly doubled since 1980, rising from 4.7% to 8.5% in the adult population.In Nepal, there is a lack of reliable and representative data on the prevalence of type 2 diabetes.Various small studies from different parts of the country have shown prevalence rates ranging from 6.3% to 8.5%.The burden of diabetes in terms of disability adjusted life years has increased almost 100% from 1990 to 2010. A pilot study in an industrial setting showed a prevalence of 4% diabetes and 31% pre-diabetes among adult employees.The prevention of type 2 diabetes through lifestyle intervention has been established by several clinical trials.These studies had a strong focus on increased physical activity and dietary modification as well as weight reduction among overweight participants. The US Diabetes Prevention Program clinical trial demonstrated that structured lifestyle interventions-such as training people with pre-diabetes to achieve modest weight loss through diet and physical activity-reduced three-year diabetes incidence by 58 percent. Studies have shown that simple modifications to the physical environment can be important in increasing physical activity and altering dietary habits. However, the translation of the knowledge to the real world setting is a challenge. Strategies to translate the preventive measures by innovative and culturally specific environmental and individual level intervention are lacking.
Work-site could be an effective platform to translate this knowledge into action as employed adults spend most of their workday waking hours at workplaces.Workplaces have additional advantages because of convenience to reach people; social support; existing formal and informal communication networks; and possible corporate behavior network.Studies have shown positive impact of diabetes prevention at work-site and other settings.Additionally,environmental changes to the work-sites can achieve modest improvement in employees' health risks, including weight and body mass index ( BMI) measures, in one year and reduced glycated hemoglobin(HbA1c) among pre-diabetic adult employee. In 2013, investigators conducted a survey of cardiovascular disease risk factors among employees of a wire industry in the eastern Nepal. The study showed that about a third of the employees were pre-diabetic and 4% had diabetes. Investigators established an ongoing work-site screening and preventive cardiovascular disease care program in the wire industry in January 2016. Furthermore, investigators conducted a qualitative study to understand willingness, facilitators and barriers to promote healthy diet in the industry cafeteria (unpublished). Building on these ground works, investigators propose implementing and evaluating the effectiveness of a work-site based lifestyle modification - an environmental modification in cafeterias and a lifestyle change education package.Investigators propose a pre-post trial with a control period to assess the effectiveness of the individual level lifestyle intervention on diabetes risk reduction among pre-diabetic (HbA1c of 5.7 to 6.4%) employees of two industries in Nepal.Investigators will provide lifestyle education to half of the randomly selected participants after 6 to 14 months of control period. Additionally, cafeteria intervention will be provided to all the pre-diabetic participants. The study aims to:
Aim 1: To measure the effectiveness of an environmental-level cafeteria intervention on diabetes risk.
Aim 2: To measure the effectiveness of an individual-level lifestyle education on the risk of diabetes prevention.
If the program is shown to be effective at these work-sites, the results of this study will be used to recommend and disseminate a sustainable environment and lifestyle interventions at work-sites to improve the health of workers, other Nepali work-sites, and to Nepal's national program for prevention and control of non- communicable disease. Furthermore, lessons from this study can be used to make recommendations or plan studies of similar work-site programs in the U.S. and other settings outside of Nepal.
- Conditions
- Diabetes
- Being tested
- Behavioural Intervention
- Keywords
- Work-site, Diabetes, Nepal
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioural InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Behavioural Intervention |
| Control | Experimental | Half of the participants will act as a control and will not receive any form of behavioural intervention. Receives: Behavioral: Behavioural Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1C
The primary outcome is absolute change in HbA1c
Measured: 24months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2019
- Study start1 Jan 2018
- Primary completion1 Sep 2020 (estimated)
- Study completion28 Feb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- We have intervention and control arm and at the same time parellel
- Masking
- None (open label)
- Enrolment
- 163 participants (actual)
Sponsor and investigators
- Lead sponsor
- B.P. Koirala Institute of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Prajjwal Pyakurel, B.P. Koirala Institute of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04161937
- Sponsor's protocol ID
- 35/2017
- Other IDs
- BLSCHP-1603, 5DP1ES02545903
- Acronym
- WSS
- Status last verified
- Nov 2019
- First submitted
- 10 Nov 2019
- Last updated
- 18 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We will decide later on
Publications
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.
PubMed 32847993
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Work-site Intervention Study to Prevent Diabetes in Nepal
- ClinicalTrials.gov ID
- NCT04161937
- Acronym / sponsor ID
- WSS / 35/2017
- Conditions
- Diabetes
- Keywords
- Work-site, Diabetes, Nepal
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 163 participants (actual)
- Lead sponsor
- B.P. Koirala Institute of Health SciencesUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Sep 2020 (estimated)
- Study completion
- 28 Feb 2021 (estimated)
- First posted
- 13 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Diabetes is the fifth leading cause of death in the most high-income countries and there is substantial evidence that it is epidemic in many low- and middle-income countries. Complications from diabetes, such as coronary artery and peripheral vascular disease, stroke, diabetic neuropathy, amputations, renal failure and blindness results in disability, reduced life expectancy and enormous health costs.The global age standardized prevalence of diabetes has nearly doubled since 1980, rising from 4.7% to 8.5% in the adult population.In Nepal, there is a lack of reliable and representative data on the prevalence of type 2 diabetes.Various small studies from different parts of the country have shown prevalence rates ranging from 6.3% to 8.5%.The burden of diabetes in terms of disability adjusted life years has increased almost 100% from 1990 to 2010. A pilot study in an industrial setting showed a prevalence of 4% diabetes and 31% pre-diabetes among adult employees.The prevention of type 2 diabetes through lifestyle intervention has been established by several clinical trials.These studies had a strong focus on increased physical activity and dietary modification as well as weight reduction among overweight participants. The US Diabetes Prevention Program clinical trial demonstrated that structured lifestyle interventions-such as training people with pre-diabetes to achieve modest weight loss through diet and physical activity-reduced three-year diabetes incidence by 58 percent. Studies have shown that simple modifications to the physical environment can be important in increasing physical activity and altering dietary habits. However, the translation of the knowledge to the real world setting is a challenge. Strategies to translate the preventive measures by innovative and culturally specific environmental and individual level intervention are lacking.
Work-site could be an effective platform to translate this knowledge into action as employed adults spend most of their workday waking hours at workplaces.Workplaces have additional advantages because of convenience to reach people; social support; existing formal and informal communication networks; and possible corporate behavior network.Studies have shown positive impact of diabetes prevention at work-site and other settings.Additionally,environmental changes to the work-sites can achieve modest improvement in employees' health risks, including weight and body mass index ( BMI) measures, in one year and reduced glycated hemoglobin(HbA1c) among pre-diabetic adult employee. In 2013, investigators conducted a survey of cardiovascular disease risk factors among employees of a wire industry in the eastern Nepal. The study showed that about a third of the employees were pre-diabetic and 4% had diabetes. Investigators established an ongoing work-site screening and preventive cardiovascular disease care program in the wire industry in January 2016. Furthermore, investigators conducted a qualitative study to understand willingness, facilitators and barriers to promote healthy diet in the industry cafeteria (unpublished). Building on these ground works, investigators propose implementing and evaluating the effectiveness of a work-site based lifestyle modification - an environmental modification in cafeterias and a lifestyle change education package.Investigators propose a pre-post trial with a control period to assess the effectiveness of the individual level lifestyle intervention on diabetes risk reduction among pre-diabetic (HbA1c of 5.7 to 6.4%) employees of two industries in Nepal.Investigators will provide lifestyle education to half of the randomly selected participants after 6 to 14 months of control period. Additionally, cafeteria intervention will be provided to all the pre-diabetic participants. The study aims to:
Aim 1: To measure the effectiveness of an environmental-level cafeteria intervention on diabetes risk.
Aim 2: To measure the effectiveness of an individual-level lifestyle education on the risk of diabetes prevention.
If the program is shown to be effective at these work-sites, the results of this study will be used to recommend and disseminate a sustainable environment and lifestyle interventions at work-sites to improve the health of workers, other Nepali work-sites, and to Nepal's national program for prevention and control of non- communicable disease. Furthermore, lessons from this study can be used to make recommendations or plan studies of similar work-site programs in the U.S. and other settings outside of Nepal.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- We have intervention and control arm and at the same time parellel
| Arm | Type | Receives |
|---|---|---|
| Behavioural Intervention | Experimental | Behavioral: Behavioural InterventionHalf 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. |
| Control | Experimental | Behavioral: Behavioural InterventionHalf of the participants will act as a control and will not receive any form of behavioural intervention. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1) Pre-diabetic participants (HbA1c 5.7-6.4%) and FBS (>=100 to 125mg/dl)
Key exclusion criteria (6 listed)
- Diabetic - HbA1c (>=6.5%) and FBS > 126mg/dl
- HbA1c <5.7% and FBS <100mg/dl
- Taking hypertension,diabetes medication
- Pregnancy
- Temporary workers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behavioural InterventionBehavior 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 | Behavioural Intervention, Control |
Primary outcome
HbA1C
Time frame: 24months
The primary outcome is absolute change in HbA1c
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2019.
- Derived from this study: PubMed 32847993Pyakurel 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.
- Individual participant dataSharing planned: Undecided. We will decide later on
Related trials for Diabetes
Recruiting
C-Carbs: A CGM-guided Approach to Teaching Carb Awareness
Type 1 Diabetes
Not yet recruiting
Negative Pressure Wound Therapy Devices in Total Knee Arthroplasty
Wound Surgical, Diabetes
Not yet recruiting
A Nurse-Led Digital Coaching Program to Improve Blood Sugar Control in Adults With Type 2 Diabetes
Type 2 Diabetes Mellitus
RecruitingPhase 3
A Study of Baricitinib (LY3009104) for the Delay of Stage 3 Type 1 Diabetes in At-Risk Children and Adults
Diabetes Mellitus, Type 1
Recruiting
Clinical Decision Support for SGLT2i After AKI in Type 2 Diabetes
Type 2 Diabetes Mellitus, Acute Kidney Injury
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioural Intervention in people with Diabetes, run by B.P. Koirala Institute of Health Sciences at 1 site in Nepal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Nepal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1C (time frame: 24months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04161937, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2019.