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

Primary Purpose

Prediabetic State

Status
Completed
Phase
Not Applicable
Locations
Nepal
Study Type
Interventional
Intervention
Diabetes Prevention Education Program
Diabetes Prevention Education brochure
Sponsored by
Norwegian University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Prediabetic State focused on measuring Patient Education, Nepal, Diabetes prevention

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kathmandu University School of Medical Science

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Diabetes Prevention Education Program

control

Arm Description

Diabetes Prevention Education Program

Diabetes Prevention Education brochure

Outcomes

Primary Outcome Measures

glycated haemoglobin (HbA1c) percent
testing capillary blood sugar by point of care HbA1c Analyser

Secondary Outcome Measures

Full Information

First Posted
August 28, 2019
Last Updated
March 15, 2022
Sponsor
Norwegian University of Science and Technology
Collaborators
Kathmandu University School of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT04074148
Brief Title
Effectiveness of Diabetes Prevention Education Program on Diabetes Prevention Among Prediabetes Population in Nepal
Acronym
DiPEP
Official Title
Effectiveness of Diabetes Prevention Education Program on Diabetes Prevention Among Prediabetes Population in Nepal: A Cluster Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
October 25, 2019 (Actual)
Primary Completion Date
September 30, 2021 (Actual)
Study Completion Date
September 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology
Collaborators
Kathmandu University School of Medical Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prediabetic State
Keywords
Patient Education, Nepal, Diabetes prevention

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
cluster randomized controlled trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
291 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Diabetes Prevention Education Program
Arm Type
Experimental
Arm Description
Diabetes Prevention Education Program
Arm Title
control
Arm Type
Experimental
Arm Description
Diabetes Prevention Education brochure
Intervention Type
Behavioral
Intervention Name(s)
Diabetes Prevention Education Program
Intervention Description
An educational lifestyle modification program, offering 4 sessions of 30 minutes theory and 30 minutes practice each, total duration 6 months
Intervention Type
Behavioral
Intervention Name(s)
Diabetes Prevention Education brochure
Intervention Description
An educational lifestyle modification brochure
Primary Outcome Measure Information:
Title
glycated haemoglobin (HbA1c) percent
Description
testing capillary blood sugar by point of care HbA1c Analyser
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bård E Kulseng, phd prof
Organizational Affiliation
Norwegian University of Science and Technology NTNU
Official's Role
Study Director
Facility Information:
Facility Name
Kathmandu University School of Medical Science
City
Kathmandu
Country
Nepal

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34819277
Citation
Shakya 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.
Results Reference
derived

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

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