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

• Sponsor: Norwegian University of Science and Technology (Other)
• Overall Status: Completed
• CT.gov ID: NCT04074148
• Collaborator: Kathmandu University School of Medical Sciences (Other)
• Enrollment: 291
• Location: 1
• Arms: 2
• Actual Duration (Months): 23.2
• Patients Per Site Per Month: 12.5

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Prediabetic State	Behavioral: Diabetes Prevention Education Program; Behavioral: Diabetes Prevention Education brochure	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 291 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: cluster randomized controlled trialcluster 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: Oct 25, 2019
• Actual Primary Completion Date: Sep 30, 2021
• Actual Study Completion Date: Sep 30, 2021

Arms and Interventions

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

Primary Outcome Measures

1. glycated haemoglobin (HbA1c) percent [6 months]

   testing capillary blood sugar by point of care HbA1c Analyser

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 64 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Kathmandu University School of Medical Science	Kathmandu		Nepal

Sponsors and Collaborators

• Norwegian University of Science and Technology
• Kathmandu University School of Medical Sciences

Investigators

• Study Director: Bård E Kulseng, phd prof, Norwegian University of Science and Technology NTNU

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Norwegian University of Science and Technology
• ClinicalTrials.gov Identifier: NCT04074148
• Other Study ID Numbers: 2019/783
• First Posted: Aug 29, 2019
• Last Update Posted: Mar 16, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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: Prediabetic State

Study Results

No Results Posted as of Mar 16, 2022