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NCT Number: NCT06587581

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

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

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Key information

Conditions

Type 2 Diabetes Mellitus(T2DM) Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ranau District Hospital and Klinik Kesihatan Kundasang

Kota Kinabalu, Sabah, 89308, Malaysia

Location contact

JEWEL BOLLAH Dr, MD,MPH

CONTACT

[email protected]

+6088877353

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Control Group

Other

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

Intervention group

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

Primary outcomes

  1. Comparison of dietary adherence at 3-month and 6-month between the usual care group and intervention group

    Time frame: Baseline, 3-month, and 6-month

    Dietary adherence to diabetic diet will be evaluated against a modified healthy eating index (HEI). A 3-day dietary record methodology (2 weekdays and 1 weekend) will be used and analyzed based on Malaysian and Singapore Food Composition Databases. The modified version of HEI used in this study consists of 14 components. Sum scores of each component yields and overall score of diet quality which will be converted into scale of zero to 100. A higher the HEI score indicates a greater adherence. The overall dietary adherence will be classified as low (below 51%), needing improvement (51-80%), or high (more than 80 points)

Secondary outcomes

  1. Comparison of glycated hemoglobin (HbA1c) at 3-month and 6-month between the usual care group and intervention group

    Time frame: Baseline, 3-month, and 6-month

    Change in HbA1c will be determined by blood test at baseline, 3 and 6 months. The HbA1c result will be retrieved from the participants' routine blood result at health clinic or hospital, which will be analyzed following a standardized analytic protocol of Ministry of Health, Malaysia

  2. Comparison of self-management behavior at 3-month and 6-month between the usual care group and intervention group

    Time frame: Baseline, 3-month, and 6-month

    The Malay version of the Summary of Diabetes Self-Care Activities (SDSCA) will be used to measure diabetes self-management activities. The SDSCA will be used to examine the participants' compliance in performing five main self-care activities. The degree of compliance or frequency with which the person engages in each self-care behavior is considered when interpreting the SDSCA scores. Higher ratings across the board typically suggest better adherence and more active diabetes self-management.

Study contacts

Contact information is provided by the study sponsor or research team.

Esther Alim Albert

CONTACT

[email protected]

6088320000

Esther Alim Albert

CONTACT

Sponsors and collaborators

Lead sponsor

Universiti Malaysia Sabah

Other

Registry information

Official study title

Effectiveness of Text Messaging Intervention to Improve Dietary Behaviors Among Patients with Type 2 Diabetes Mellitus in Low Resource Area of Sabah: a Randomized, Open-Label, Controlled Trial

Acronym: DTEXT-SBH

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Sep 19, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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