NCT04074148

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
291

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 28, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 29, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

October 25, 2019

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2021

Completed
Last Updated

March 16, 2022

Status Verified

March 1, 2022

Enrollment Period

1.9 years

First QC Date

August 28, 2019

Last Update Submit

March 15, 2022

Conditions

Prediabetic State

Keywords

Patient EducationNepalDiabetes prevention

Outcome Measures

Primary Outcomes (1)

  • glycated haemoglobin (HbA1c) percent

    testing capillary blood sugar by point of care HbA1c Analyser

    6 months

Study Arms (2)

Diabetes Prevention Education Program

EXPERIMENTAL

Diabetes Prevention Education Program

Behavioral: Diabetes Prevention Education Program

control

EXPERIMENTAL

Diabetes Prevention Education brochure

Behavioral: Diabetes Prevention Education brochure

Interventions

Diabetes Prevention Education ProgramBEHAVIORAL

An educational lifestyle modification program, offering 4 sessions of 30 minutes theory and 30 minutes practice each, total duration 6 months

Diabetes Prevention Education Program
Diabetes Prevention Education brochureBEHAVIORAL

An educational lifestyle modification brochure

control

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kathmandu University School of Medical Science

Kathmandu, Nepal

Location

Related Publications (3)

  • 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.

    PMID: 38264365DERIVED

  • Shakya 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.

    PMID: 36581426DERIVED

  • 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.

    PMID: 34819277DERIVED

MeSH Terms

Conditions

Prediabetic State

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Bård E Kulseng, phd prof

    Norwegian University of Science and Technology NTNU

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: cluster randomized controlled trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 28, 2019

First Posted

August 29, 2019

Study Start

October 25, 2019

Primary Completion

September 30, 2021

Study Completion

September 30, 2021

Last Updated

March 16, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

NE(1)