Self Management of Type 2 Diabetes Using a Text Based Mobile Health (Mhealth) Intervention in Nepal

April 28, 2026 updated by: Namuna Shrestha, University of Huddersfield

Self Management of Type 2 Diabetes Using a Co-designed Mobile Health (Mhealth) Intervention in Nepal: A Randomized Control Trial

Background: The global prevalence of diabetes is increasing particularly in low and middle income countries like Nepal with the number expected to rise in the near future. Advances in technology have led to greater use of mobile health (mhealth) for managing chronic diseases. mhealth offers a cost-effective way to improve health outcomes with evidence supporting feasibility, acceptability and effectiveness in resource-limited settings like Nepal. However, while mhealth has shown promising results in promoting positive health behaviour and improving service utilization for chronic conditions, its potential for self-management of type 2 diabetes in Nepal is yet to be evaluated. This study thus aims to determine the effectiveness and acceptability of a text based mhealth intervention that improve self-management in people with Type 2 Diabetes in Nepal.

Methods: This study is a 6 month, open-label, two-armed parallel group randomized control trial among 154 participants with type 2 diabetes. Participants will be randomly assigned to either intervention or control group on a 1:1 basis. The intervention group will receive a text based mhealth intervention (text messages) in addition to standard care while the control group will receive only standard care. Baseline data will be collected using a structured questionnaire. Follow up will be done 6 months after the intervention. The primary outcome of the study will be a difference in mean in the HbA1c level from baseline to follow up. The secondary outcomes include changes in diabetes self-care activities, self-efficacy, social-support, diabetes related stress, quality of life and acceptability of the intervention. An economic evaluation will be conducted using a patient perspective. Data will be analyzed using Stata version 13.0.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Background and rationale The number of people living with diabetes has increased globally and is on rapid rise among low and middle income countries (LMICs). In 2021, there were 537 million people living with diabetes and this number is expected to rise to 643 million by 2030 and 783 million by 2045. More than three in four adults with diabetes are living in LMICs. Diabetes accounted for 6.6 million deaths in 2021 and is a major cause of blindness, kidney failure, heart attack, stroke and lower limb amputation. Following the global trend, the prevalence of diabetes has been increasing in Nepal. The International Diabetes Federation (IDF) estimated a prevalence of 8.7% among Nepalese population and the proportion is to rise to 9.4% by 2045.

The burgeoning burden of disease may place serious challenges on the resource constrained national health system due to complications resulting from the disease, coupled with issues around service availability; readiness and limited awareness among the people living with diabetes.

Access to care is of utmost importance for people with diabetes in the course of their disease however, the availability and utilisation of diabetes care services vary across socio-economic and geographical distribution indicating challenges in accessing the diabetes care services. WHO STEPS survey Nepal 2019 reported about three-fourth (73.5%) of the people were not aware of their raised blood sugar. Despite being aware of their condition, about 6% were not on treatment. Similarly, only 70% of adults with raised blood sugar reported compliance to medications to control their blood sugar. In addition, public health facilities in Nepal are not ready to deal with the increasing burden of NCDs including diabetes in terms of qualified health staff, training, availability of equipment and medicines as well as availability of diabetes services in general.

Early diagnosis, treatment and self-management are essential for the prevention and control of the disease. Self-management refers to the activities and behaviour undertaken by the individuals to control and treat their conditions to improve their health outcomes with support from family members, friends and relatives and in consultation with health service providers. The American Association of Diabetes Educators (AADE) has identified seven self-care behaviours for successful and effective self-management of diabetes as healthy coping, healthy eating, being active, taking medication, monitoring, reducing risks and problem solving. Self-management has been proved to be cost effective through reduction in hospital admissions and health care costs. Besides, it is shown to improve HbA1c level and has a positive effect on other clinical, psychosocial, and behavioural aspects of diabetes along with improvement in quality of life by reducing onset and/or advancement of diabetes complications.

With the development of technology, the application of mobile health (mhealth) is becoming increasingly popular in the self-care of chronic diseases. mhealth interventions have been proved to be a therapeutic strategy that could improve the diabetes management despite their economic status. According to the National Population and Housing Census report 2021, about three-fourth (73%) of the households have at least some form of smartphone penetration and 37.9% household with internet access in Nepal.

In the resource limited countries like Nepal, mhealth technology can be a cost-effective approach to deliver care and improve the health outcomes. There are studies demonstrating the feasibility, acceptability and even effectiveness of mhealth in improving the health outcomes for hypertension in Nepal. There is also existing evidence of mhealth as an effective means to communicate health related information and supporting positive behaviour change in a short period of time. Despite availability of body of evidence on acceptability of mhealth in improving service utilization and health outcomes for chronic conditions, the application of behaviour change interventions through mhealth for self-management of diabetes is yet to be evaluated.

Objectives This study aims to determine the effectiveness and acceptability of a text based mhealth intervention that improve self-management in people with Type 2 Diabetes using a co-designed approach in Nepal.

Objective 1: To determine effectiveness and cost effectiveness of text based mhealth intervention in improving self-management (HbA1c level, self-efficacy, perceived support, diabetes related stress, health related quality of life and self-care behaviors) Objective 2: To determine acceptability of a text based mhealth intervention in improving self-management among people with type 2 diabetes

Study Type

Interventional

Enrollment (Estimated)

154

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Nepal
    • Bagmati
      • Dhulikhel, Bagmati, Nepal
        • Dhulikhel Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • adults aged 18 years and above
  • clinical diagnosis of type 2 diabetes
  • participant who have a mobile phone and is able to read the message on their own or with the help of family members.

Exclusion Criteria:

  • not physically or mentally able, not able to provide consent
  • pregnant in case of female

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
The control group will be receive usual care they have been getting. At the end of the intervention, they will be provided with a leaflet that contains messages that was included in the mhealth intervention.
Experimental: Intervention
The intervention group will receive a text-based mhealth (text messages) in addition to standard care which they are used to receiving.
Behavioral: mobile health (mhealth)
The intervention will include a text-based mhealth component, designed using a behaviour change framework (Behaviour Change Wheel). The development process will be further informed by a formative research exploring perspectives of both health service providers and users on use of text based mhealth for supporting self-management in people with type 2 diabetes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in HbA1c level
Time Frame: six months
change in mean HbA1c between intervention and control group from baseline to follow up (6 months after the intervention)
six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Huddersfield

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 16, 2025

Primary Completion (Actual)

December 1, 2025

Study Completion (Estimated)

September 30, 2026

Study Registration Dates

First Submitted

September 30, 2024

First Submitted That Met QC Criteria

September 30, 2024

First Posted (Actual)

October 2, 2024

Study Record Updates

Last Update Posted (Actual)

May 4, 2026

Last Update Submitted That Met QC Criteria

April 28, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UHuddersfieldProtV000001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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