Prediabetic StateDiPEPNCT04074148
Effectiveness of Diabetes Prevention Education Program on Diabetes Prevention Among Prediabetes Population in Nepal
A study testing Diabetes Prevention Education Program and Diabetes Prevention Education brochure in people with Prediabetic State, run by Norwegian University of Science and Technology at 1 site in Nepal.
Trial summary
Background: The prediabetes population is a high risk group for developing diabetes and is also associated with a higher risk of micro- and macrovascular complications. Prevalence of prediabetes is also increasing in Nepal (10.3%). Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Prediabetic State
- What is being tested?
- Diabetes Prevention Education Program and Diabetes Prevention Education brochure
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 291 participants
- Where
- 1 siteNepal
- Study dates
- 25 Oct 2019to 30 Sep 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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Permanent residents of Dhulikhel municipality or Lalitpur Metropolitan City (Patan)
- Indian Diabetes Risk Score 60 or higher
- Prediabetes: glycated haemoglobin (HbA1c) 5.7-6.4 %
- Random blood sugar ≥ 140 to ≤ 250 mg/dl
Who cannot join
- type 1 diabetes (self-report)
- Type 2 diabetes
- Under medication
- HbA1c criteria (≥ 6.5 %)
- Currently pregnant
- Critically ill patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Diabetes Prevention Education Program on Diabetes Prevention Among Prediabetes Population in Nepal: A Cluster Randomized Controlled Trial
Background: The prediabetes population is a high risk group for developing diabetes and is also associated with a higher risk of micro- and macrovascular complications. Prevalence of prediabetes is also increasing in Nepal (10.3%). Therefore, appropriate strategies should be developed to detect prediabetes and prevent its complications. Early detection of prediabetes offers opportunity for intervention to prevent diabetes either by reverting into normoglycemia or stabilizing blood glucose levels. Even a small shift in weight loss and reduction of glycated haemoglobin (HbA1c) (i.e., a change in HbA1c of 0.5%) can be significant in reducing cardiometabolic risk. Therefore, we propose to develop a culturally tailored Diabetes Prevention Education Program (DiPEP) for Nepal and implement this program among a prediabetes population with the aim to prevent diabetes.
Aims: Primary aim of the research is to test the effectiveness of a Diabetes Prevention Education Program (DiPEP) in lowering glycated haemoglobin (HbA1c %) among a pre-diabetes population in Nepal. Our secondary aims are to test the effectiveness of DiPEP in improving health literacy in diabetes, reducing weight, improving healthy diet and physical activity. We also aim to explore acceptability and usability of DiPEP among a prediabetes population and perception of adoption and sustainability of DiPEP in the health sector of Nepal.
Significance: Prevention of diabetes, especially Type 2 Diabetes Mellitus (T2DM) is proven, possible and powerful. It is more cost effective than spending huge money in treatment and usual care. It requires modification of dietary and exercise behavior, which are efficacious, safe, and cost-effective measures. Therefore, a culturally tailored DiPEP intervention program for Nepal will serve as an additional reference resource for the Non-Communicable Disease division of Ministry of health to develop and implement national diabetes prevention program if they decide such program is important for Nepal. It will be helpful to achieve Non-communicable disease target 3.4 of the Sustainable Development Goal by Nepal government's Ministry of Health. Additionally, it will be beneficial for the prediabetes population who could have developed T2DM in short span of time if they had been undiagnosed and unconsidered. Therefore, the main significance of the study is it will provide knowledge and environment to prevent diabetes at their community level.
- Conditions
- Prediabetic State
- Being tested
- Diabetes Prevention Education Program, Diabetes Prevention Education brochure
- Keywords
- Patient Education, Nepal, Diabetes prevention
- Medical subject headings
- Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diabetes Prevention Education ProgramBehavioural
An educational lifestyle modification program, offering 4 sessions of 30 minutes theory and 30 minutes practice each, total duration 6 months
Diabetes Prevention Education brochureBehavioural
An educational lifestyle modification brochure
| Study group | Role | What they receive |
|---|---|---|
| Diabetes Prevention Education Program | Experimental | Diabetes Prevention Education Program Receives: Behavioral: Diabetes Prevention Education Program |
| control | Experimental | Diabetes Prevention Education brochure Receives: Behavioral: Diabetes Prevention Education brochure |
What is being measured
The primary outcome is the main question the study is designed to answer.
glycated haemoglobin (HbA1c) percent
testing capillary blood sugar by point of care HbA1c Analyser
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2019
- Study start25 Oct 2019
- Primary completion30 Sep 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Prediabetic StateStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe sponsor's other registered studies.
- 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
- cluster randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 291 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Kathmandu University School of Medical Sciences
- Responsible party
- Sponsor
- Investigators
- Bård E Kulseng, phd prof, Study director, Norwegian University of Science and Technology NTNU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04074148
- Sponsor's protocol ID
- 2019/783
- Acronym
- DiPEP
- Status last verified
- Mar 2022
- First submitted
- 28 Aug 2019
- Last updated
- 16 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Shakya P, Shrestha A, Bajracharya M, Shrestha A, Kulseng BE, Karmacharya BM, Shrestha S, Das S, Shrestha IB, Barun K, Shrestha N, Skovlund E, Sen A. Effectiveness of a group-based Diabetes Prevention Education Program (DiPEP) in a population with pre-diabetes: a cluster randomised controlled trial in Nepal. BMJ Nutr Prev Health. 2023 Dec;6(2):253-263. doi: 10.1136/bmjnph-2023-000702. Epub 2023 Nov 7.
PubMed 38264365Shakya P, Shrestha A, Karmacharya BM, Shrestha A, Kulseng BE, Skovlund E, Sen A. Prevalence of prediabetes and associated factors of prediabetic stages: a cross-sectional study among adults in Nepal. BMJ Open. 2022 Dec 29;12(12):e064516. doi: 10.1136/bmjopen-2022-064516.
PubMed 36581426Shakya P, Shrestha A, Karmacharya BM, Shrestha A, Kulseng BE, Skovlund E, Sen A. Diabetes Prevention Education Program in a population with pre-diabetes in Nepal: a study protocol of a cluster randomised controlled trial (DiPEP). BMJ Open. 2021 Nov 24;11(11):e047067. doi: 10.1136/bmjopen-2020-047067.
PubMed 34819277
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Diabetes Prevention Education Program on Diabetes Prevention Among Prediabetes Population in Nepal: A Cluster Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04074148
- Acronym / sponsor ID
- DiPEP / 2019/783
- Conditions
- Prediabetic State
- Keywords
- Patient Education, Nepal, Diabetes prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 291 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- Kathmandu University School of Medical Sciences
- Study start
- 25 Oct 2019 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 29 Aug 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.
Background: The prediabetes population is a high risk group for developing diabetes and is also associated with a higher risk of micro- and macrovascular complications. Prevalence of prediabetes is also increasing in Nepal (10.3%). Therefore, appropriate strategies should be developed to detect prediabetes and prevent its complications. Early detection of prediabetes offers opportunity for intervention to prevent diabetes either by reverting into normoglycemia or stabilizing blood glucose levels. Even a small shift in weight loss and reduction of glycated haemoglobin (HbA1c) (i.e., a change in HbA1c of 0.5%) can be significant in reducing cardiometabolic risk. Therefore, we propose to develop a culturally tailored Diabetes Prevention Education Program (DiPEP) for Nepal and implement this program among a prediabetes population with the aim to prevent diabetes.
Aims: Primary aim of the research is to test the effectiveness of a Diabetes Prevention Education Program (DiPEP) in lowering glycated haemoglobin (HbA1c %) among a pre-diabetes population in Nepal. Our secondary aims are to test the effectiveness of DiPEP in improving health literacy in diabetes, reducing weight, improving healthy diet and physical activity. We also aim to explore acceptability and usability of DiPEP among a prediabetes population and perception of adoption and sustainability of DiPEP in the health sector of Nepal.
Significance: Prevention of diabetes, especially Type 2 Diabetes Mellitus (T2DM) is proven, possible and powerful. It is more cost effective than spending huge money in treatment and usual care. It requires modification of dietary and exercise behavior, which are efficacious, safe, and cost-effective measures. Therefore, a culturally tailored DiPEP intervention program for Nepal will serve as an additional reference resource for the Non-Communicable Disease division of Ministry of health to develop and implement national diabetes prevention program if they decide such program is important for Nepal. It will be helpful to achieve Non-communicable disease target 3.4 of the Sustainable Development Goal by Nepal government's Ministry of Health. Additionally, it will be beneficial for the prediabetes population who could have developed T2DM in short span of time if they had been undiagnosed and unconsidered. Therefore, the main significance of the study is it will provide knowledge and environment to prevent diabetes at their community level.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- cluster randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Diabetes Prevention Education Program | Experimental | Behavioral: Diabetes Prevention Education ProgramDiabetes Prevention Education Program |
| control | Experimental | Behavioral: Diabetes Prevention Education brochureDiabetes Prevention Education brochure |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Permanent residents of Dhulikhel municipality or Lalitpur Metropolitan City (Patan)
- Indian Diabetes Risk Score 60 or higher
- Prediabetes: glycated haemoglobin (HbA1c) 5.7-6.4 %
- Random blood sugar ≥ 140 to ≤ 250 mg/dl
Key exclusion criteria (6 listed)
- type 1 diabetes (self-report)
- Type 2 diabetes
- Under medication
- HbA1c criteria (≥ 6.5 %)
- Currently pregnant
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 |
|---|---|---|
| Diabetes Prevention Education ProgramAn educational lifestyle modification program, offering 4 sessions of 30 minutes theory and 30 minutes practice each, total duration 6 months | Behavioural | Diabetes Prevention Education Program |
| Diabetes Prevention Education brochureAn educational lifestyle modification brochure | Behavioural | control |
Primary outcome
glycated haemoglobin (HbA1c) percent
Time frame: 6 months
testing capillary blood sugar by point of care HbA1c Analyser
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2022.
- Derived from this study: PubMed 38264365Shakya P, Shrestha A, Bajracharya M, Shrestha A, Kulseng BE, Karmacharya BM, Shrestha S, Das S, Shrestha IB, Barun K, Shrestha N, Skovlund E, Sen A. Effectiveness of a group-based Diabetes Prevention Education Program (DiPEP) in a population with pre-diabetes: a cluster randomised controlled trial in Nepal. BMJ Nutr Prev Health. 2023 Dec;6(2):253-263. doi: 10.1136/bmjnph-2023-000702. Epub 2023 Nov 7.
- Derived from this study: PubMed 36581426Shakya P, Shrestha A, Karmacharya BM, Shrestha A, Kulseng BE, Skovlund E, Sen A. Prevalence of prediabetes and associated factors of prediabetic stages: a cross-sectional study among adults in Nepal. BMJ Open. 2022 Dec 29;12(12):e064516. doi: 10.1136/bmjopen-2022-064516.
- Derived from this study: PubMed 34819277Shakya P, Shrestha A, Karmacharya BM, Shrestha A, Kulseng BE, Skovlund E, Sen A. Diabetes Prevention Education Program in a population with pre-diabetes in Nepal: a study protocol of a cluster randomised controlled trial (DiPEP). BMJ Open. 2021 Nov 24;11(11):e047067. doi: 10.1136/bmjopen-2020-047067.
- Individual participant dataSharing planned: No
Related trials for Prediabetic State
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
RecruitingObservational study
Food-i-Sense Analytics: Integrating AI Into Continuous Glucose Monitoring Data Analysis for Precision Nutrition.
Prediabetes (Insulin Resistance, Impaired Glucose Tolerance), Artificial Intelligence Mobile Application
RecruitingPhase 3
A Study of Orforglipron in Participants With Overweight at Risk of Development of Obesity-Related Complications or Progression to Class 1 Obesity
Overweight, Prediabetic State
Enrolling by invitationEarly Phase 1
Truway Diagnostic Tools in Primary Care
Chronic Disease, Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight
Recruiting
CGM-Enhanced DPP to Prevent Type 2 Diabetes in Adults With Prediabetes
PreDiabetes
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.
Bård E Kulseng, phd prof study director
Norwegian University of Science and Technology NTNU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diabetes Prevention Education Program and Diabetes Prevention Education brochure in people with Prediabetic State, run by Norwegian University of Science and Technology 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 4 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: finished, as of the sponsor's last update on 16 Mar 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
glycated haemoglobin (HbA1c) percent (time frame: 6 months). 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 NCT04074148, which also lists 3 linked publications.
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 16 Mar 2022.