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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 : Not yet recruiting
First Posted : August 29, 2019
Last Update Posted : September 18, 2019
Sponsor:
Collaborator:
Kathmandu University School of Medical Sciences
Information provided by (Responsible Party):
Norwegian University of Science and Technology

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 480 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
Estimated Study Start Date : November 2019
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prediabetes

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




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



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
  • Indian Diabetes Risk Score 30 or higher
  • Prediabetes: glycated haemoglobin (HbA1c) 5.7-6.4 %

Exclusion Criteria:

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

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


Contacts
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Contact: Abhijit Sen, phd +4773412950 abhijit.sen@ntnu.no
Contact: Bård E Kulseng, phd prof baard.kulseng@ntnu.no

Locations
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Nepal
Kathmandu University School of Medical Science Not yet recruiting
Kathmandu, Nepal
Contact: Pushpanajali Shakya       shakya.pushpanjali@yahoo.com   
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

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Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT04074148     History of Changes
Other Study ID Numbers: 2019/783
First Posted: August 29, 2019    Key Record Dates
Last Update Posted: September 18, 2019
Last Verified: September 2019
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