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

NCT06623006 | Active Not Recruiting DMC

• 1 other identifier: UHuddersfieldProtV000001
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

type 2 diabetes, mhealth, self-management, Nepal

Outcome Measures

Primary Outcomes (1)

• Change in HbA1c level

  change in mean HbA1c between intervention and control group from baseline to follow up (6 months after the intervention)

  six months

Study Arms (2)

Control group

NO INTERVENTION

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.

Intervention

EXPERIMENTAL

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)

Interventions

mobile health (mhealth) BEHAVIORAL

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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Huddersfield: lead

Study Sites (1)

Dhulikhel Hospital

Dhulikhel, Bagmati, Nepal

Location

Related Publications (18)

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  PMID: 32149712 BACKGROUND

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  PMID: 25164529 BACKGROUND

• American Association of Diabetes Educators. An Effective Model of Diabetes Care and Education: Revising the AADE7 Self-Care Behaviors(R). Diabetes Educ. 2020 Apr;46(2):139-160. doi: 10.1177/0145721719894903. Epub 2020 Jan 12.

  PMID: 31928334 BACKGROUND

• Powers MA, Bardsley J, Cypress M, Duker P, Funnell MM, Fischl AH, Maryniuk MD, Siminerio L, Vivian E. Diabetes Self-Management Education and Support in Type 2 Diabetes: A Joint Position Statement of the American Diabetes Association, the American Association of Diabetes Educators, and the Academy of Nutrition and Dietetics. J Acad Nutr Diet. 2015 Aug;115(8):1323-34. doi: 10.1016/j.jand.2015.05.012. Epub 2015 Jun 5. No abstract available.

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• Shrestha N, Simkhada P, Kurmi O, Gautam S, Karmacharya B, Shrestha A, Tamrakar R, Poudel AN. Self-management of type 2 diabetes using a co-designed text based mobile health (mHealth) intervention in Nepal: A study protocol for randomised controlled trial. PLoS One. 2025 Nov 4;20(11):e0335333. doi: 10.1371/journal.pone.0335333. eCollection 2025.

  PMID: 41187147 DERIVED

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MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Telemedicine

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Delivery of Health Care; Patient Care Management; Health Services Administration

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD student-full time

Study Record Dates

• First Submitted: September 30, 2024
• First Posted: October 2, 2024
• Study Start: September 16, 2025
• Primary Completion: December 1, 2025
• Study Completion (Estimated): September 30, 2026
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

NE (1)