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

Norwegian University of Science and Technology

Status: Completed

Conditions: Prediabetic State

Treatments: Behavioral: Diabetes Prevention Education brochure; Behavioral: Diabetes Prevention Education Program

Study type: Interventional

Funder types: Other

Identifiers

NCT04074148

2019/783

Details and patient eligibility

About

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.

Enrollment: 291 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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291 participants in 2 patient groups

Diabetes Prevention Education Program

Experimental group

Description:

Diabetes Prevention Education Program

Treatment:

Behavioral: Diabetes Prevention Education Program

control

Experimental group

Description:

Diabetes Prevention Education brochure

Treatment:

Behavioral: Diabetes Prevention Education brochure