Clinical trial NCT04074148: Effectiveness of Diabetes Prevention Education Program on Diabetes Prevention Among Prediabetes Population in Nepal
Official title: Effectiveness of Diabetes Prevention Education Program on Diabetes Prevention Among Prediabetes Population in Nepal: A Cluster Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prediabetic State
Keywords: Patient Education
Nepal
Diabetes prevention
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: Kathmandu University School of Medical Sciences
First posted: 2019-08-29
Enrollment: 291
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: cluster randomized controlled trial
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: glycated haemoglobin (HbA1c) percent
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Kathmandu
country: Nepal
facility: Kathmandu University School of Medical Science
Study officials:
affiliation: Norwegian University of Science and Technology NTNU
name: Bård E Kulseng, phd prof
role: STUDY_DIRECTOR
References:
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.