Effectiveness of Text Messaging Intervention to Improve Dietary Behaviors Among Patients with Type 2 Diabetes Mellitus in Low Resource Area of Sabah (DTEXT-SBH)

NCT ID: NCT06587581

Last Updated: 2024-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-31

Study Completion Date

2025-07-31

Brief Summary

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The goal of this clinical trial is to learn if sending three (3) text messages per week over a six (6) months period to people with Type 2 Diabetes in areas with lack access to dietitian could help them stick to a healthier diet. The main questions it aims to answer are:

* Does a mobile phone text-message intervention improve dietary adherence among T2DM patients?
* Does a mobile phone text-message intervention improve HbA1c and self-management among T2DM patients? Researchers will compare dietary adherence, HbA1c changes and self-management behaviors between the usual care group and intervention group.

Participants will:

* Be given three (3) text messages per week over a six (6) months period for the intervention group
* Both usual care and intervention group will be given standard medical nutrition therapy at baseline, 3rd and 6th months visits to the clinic

Detailed Description

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Conditions

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Type 2 Diabetes Mellitus(T2DM)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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T2DM Medical Nutrition Therapy

Participants from control groups will receive the usual care, which will be a three-monthly nutrition consultation by a visiting dietitian

Group Type ACTIVE_COMPARATOR

Control Group

Intervention Type OTHER

Participants from the intervention group will receive the usual care over the 6-month intervention period

T2DM Medical Nutrition Therapy and Text Messages

Participants from the intervention group will receive the usual care and an additional three text messages per week via WhatsApp over the 6-month intervention period

Group Type EXPERIMENTAL

Intervention Group

Intervention Type OTHER

Participants from the intervention group will receive the usual care and an additional three text messages per week via WhatsApp over the 6-month intervention period

Interventions

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Control Group

Participants from the intervention group will receive the usual care over the 6-month intervention period

Intervention Type OTHER

Intervention Group

Participants from the intervention group will receive the usual care and an additional three text messages per week via WhatsApp over the 6-month intervention period

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* have type 2 diabetes.
* own a mobile phone.
* able to use WhatsApp.
* able to read and speak Bahasa Malaysia.
* have an HbA1c level above 7.0%.
* have not seen a dietitian in the previous 6 months.

Exclusion Criteria

* individuals with type 1 diabetes mellitus and gestational diabetes mellitus.
* patients with cognitive impairment affecting memory, attention, language, and problem-solving skills.
* those with advanced diabetic complications, such as kidney failure and neuropathy.
* individuals lacking regular access to a mobile phone or with poor network connectivity.
* pregnant individuals or those planning to get pregnant in the next 6 months, as well as those currently nursing.
* individuals with major illnesses like cancer or advanced heart disease.
* those planning major surgery or gastric bypass in the next 6 months.
* institutionalized individuals, such as those in nursing homes, old folks\' homes, or imprisoned.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universiti Malaysia Sabah

OTHER

Sponsor Role lead

Responsible Party

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ESTHER ALIM ALBERT

REGISTERED DIETITIAN

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ranau District Hospital and Klinik Kesihatan Kundasang

Kota Kinabalu, Sabah, Malaysia

Site Status

Countries

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Malaysia

Central Contacts

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Esther Alim Albert

Role: CONTACT

6088320000

Esther Alim Albert

Role: CONTACT

Facility Contacts

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JEWEL BOLLAH Dr, MD,MPH

Role: primary

+6088877353

References

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Arora S, Peters AL, Burner E, Lam CN, Menchine M. Trial to examine text message-based mHealth in emergency department patients with diabetes (TExT-MED): a randomized controlled trial. Ann Emerg Med. 2014 Jun;63(6):745-54.e6. doi: 10.1016/j.annemergmed.2013.10.012. Epub 2013 Nov 11.

Reference Type BACKGROUND
PMID: 24225332 (View on PubMed)

Ramachandran A, Snehalatha C, Ram J, Selvam S, Simon M, Nanditha A, Shetty AS, Godsland IF, Chaturvedi N, Majeed A, Oliver N, Toumazou C, Alberti KG, Johnston DG. Effectiveness of mobile phone messaging in prevention of type 2 diabetes by lifestyle modification in men in India: a prospective, parallel-group, randomised controlled trial. Lancet Diabetes Endocrinol. 2013 Nov;1(3):191-8. doi: 10.1016/S2213-8587(13)70067-6. Epub 2013 Sep 11.

Reference Type BACKGROUND
PMID: 24622367 (View on PubMed)

Other Identifiers

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RSCH ID-24-01119-NHX

Identifier Type: -

Identifier Source: org_study_id

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