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

NCT06623006 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 154

Last updated 2026-05-04

No results posted yet for this study

Summary

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.

Conditions

  • Type 2 Diabetes Mellitus (T2DM)

Interventions

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.

Sponsors & Collaborators

  • University of Huddersfield

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-16
Primary Completion
2025-12-01
Completion
2026-09-30

Countries

  • Nepal

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06623006 on ClinicalTrials.gov