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Not yet recruiting 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)

No phase Interventional Type 2 Diabetes Mellitus(T2DM)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Control Group, Intervention Group.
Who it may be relevant to
Registry conditions: Type 2 Diabetes Mellitus(T2DM). Basic parameters: 18 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Malaysia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official 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

Overview

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

Interventions

  • Other Control Group
    Participants from the intervention group will receive the usual care over the 6-month intervention period
  • 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

Primary outcome measures

  • 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]
Secondary outcome measures (2)
  • 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]
  • 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Health services research

Study locations

Malaysia · 1 center
  • Ranau District Hospital and Klinik Kesihatan Kundasang — Kota Kinabalu

Publications

  • 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. PMID 24225332
  • 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 PMID 24622367

Identifiers

NCT: NCT06587581 · RSCH ID-24-01119-NHX

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗