Clinical trial 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)
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Type 2 Diabetes Mellitus(T2DM)
Keywords: type 2 diabetes mellitus
lack access to dietitian
eHealth
Dietary adherence
low resource area
Lead sponsor: Universiti Malaysia Sabah
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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


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\&#39; homes, or imprisoned.

Primary outcomes:
measure: Comparison of dietary adherence at 3-month and 6-month between the usual care group and intervention group
timeFrame: Baseline, 3-month, and 6-month
Secondary outcomes:
measure: Comparison of glycated hemoglobin (HbA1c) at 3-month and 6-month between the usual care group and intervention group
timeFrame: Baseline, 3-month, and 6-month
measure: Comparison of self-management behavior at 3-month and 6-month between the usual care group and intervention group
timeFrame: Baseline, 3-month, and 6-month
Other outcomes:
Locations:
city: Kota Kinabalu
country: Malaysia
facility: Ranau District Hospital and Klinik Kesihatan Kundasang
state: Sabah
Study officials:
References:
citation: 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.
citation: 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.