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Effectiveness of Diabetes Prevention Education Program on Diabetes Prevention Among Prediabetes Population in Nepal (DiPEP)

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ClinicalTrials.gov Identifier: NCT04074148
Recruitment Status : Completed
First Posted : August 29, 2019
Last Update Posted : October 11, 2021
Sponsor:
Collaborator:
Kathmandu University School of Medical Sciences
Information provided by (Responsible Party):
Norwegian University of Science and Technology

Study Description
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Brief 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%). 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.


Condition or disease Intervention/treatment Phase
Prediabetic State Behavioral: Diabetes Prevention Education Program Behavioral: Diabetes Prevention Education brochure Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: cluster randomized controlled trial
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effectiveness of Diabetes Prevention Education Program on Diabetes Prevention Among Prediabetes Population in Nepal: A Cluster Randomized Controlled Trial
Actual Study Start Date : October 25, 2019
Actual Primary Completion Date : September 30, 2021
Actual Study Completion Date : September 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prediabetes

Arms and Interventions
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Arm Intervention/treatment
Experimental: Diabetes Prevention Education Program
Diabetes Prevention Education Program
 Behavioral: Diabetes Prevention Education Program
An educational lifestyle modification program, offering 4 sessions of 30 minutes theory and 30 minutes practice each, total duration 6 months
Experimental: control
Diabetes Prevention Education brochure
 Behavioral: Diabetes Prevention Education brochure
An educational lifestyle modification brochure


Outcome Measures
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Primary Outcome Measures :
  1. glycated haemoglobin (HbA1c) percent [ Time Frame: 6 months ]
    testing capillary blood sugar by point of care HbA1c Analyser


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • type 1 diabetes (self-report)
  • Type 2 diabetes
  • Under medication
  • HbA1c criteria (≥ 6.5 %)
  • Currently pregnant
  • Critically ill patients
Contacts and Locations
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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): NCT04074148


Locations
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Nepal
Kathmandu University School of Medical Science
Kathmandu, Nepal
Sponsors and Collaborators
Norwegian University of Science and Technology
Kathmandu University School of Medical Sciences
Investigators
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Study Director: Bård E Kulseng, phd prof Norwegian University of Science and Technology NTNU
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT04074148    
Other Study ID Numbers: 2019/783
First Posted: August 29, 2019    Key Record Dates
Last Update Posted: October 11, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 Norwegian University of Science and Technology:
Patient Education
Nepal
Diabetes prevention
Additional relevant MeSH terms:
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Prediabetic State
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases