Type 2 Diabetes Mellitus(T2DM)DTEXT-SBHNCT06587581
Effectiveness of Text Messaging Intervention to Improve Dietary Behaviors Among Patients with Type 2 Diabetes Mellitus in Low Resource Area of Sabah (DTEXT-SBH)
A study testing Intervention Group in people with Type 2 Diabetes Mellitus(T2DM), run by Universiti Malaysia Sabah at 1 site in Malaysia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Type 2 Diabetes Mellitus(T2DM)
- What is being tested?
- Intervention Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteMalaysia
- Study dates
- Jan 2025to Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Esther Alim Albert contact
Malaysia1 site
Ranau District Hospital and Klinik Kesihatan Kundasang
Kota Kinabalu, Sabah, 89308
JEWEL BOLLAH Dr, MD,MPH, +6088877353, drjewelbollah@gmail.com
About this study
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
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.
Read more
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
- Conditions
- Type 2 Diabetes Mellitus(T2DM)
- Being tested
- Control Group, Intervention Group
- Keywords
- type 2 diabetes mellitus, lack access to dietitian, eHealth, Dietary adherence, low resource area
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control GroupOther
Participants from the intervention group will receive the usual care over the 6-month intervention period
Intervention GroupOther
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
| Study group | Role | What they receive |
|---|---|---|
| T2DM Medical Nutrition Therapy | Active comparator | Participants from control groups will receive the usual care, which will be a three-monthly nutrition consultation by a visiting dietitian Receives: Other: Control Group |
| T2DM Medical Nutrition Therapy and Text Messages | Experimental | 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 Receives: Other: Intervention Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of dietary adherence at 3-month and 6-month between the usual care group and intervention group
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)
Measured: Baseline, 3-month, and 6-month
Secondary outcomes (2)
Comparison of glycated hemoglobin (HbA1c) at 3-month and 6-month between the usual care group and intervention group
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
Measured: 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
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.
Measured: Baseline, 3-month, and 6-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study startJan 2025 (estimated)
- Primary completionJul 2025 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes Mellitus(T2DM)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universiti Malaysia Sabah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ESTHER ALIM ALBERT, Universiti Malaysia Sabah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06587581
- Sponsor's protocol ID
- RSCH ID-24-01119-NHX
- Acronym
- DTEXT-SBH
- Status last verified
- Sep 2024
- First submitted
- 5 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 24225332Ramachandran 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.
PubMed 24622367
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06587581
- Acronym / sponsor ID
- DTEXT-SBH / RSCH ID-24-01119-NHX
- Conditions
- Type 2 Diabetes Mellitus(T2DM)
- Keywords
- type 2 diabetes mellitus, lack access to dietitian, eHealth, Dietary adherence, low resource area
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Universiti Malaysia SabahUniversity, hospital or other
- Study start
- Jan 2025 (estimated)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| T2DM Medical Nutrition Therapy | Active comparator | Other: Control GroupParticipants from control groups will receive the usual care, which will be a three-monthly nutrition consultation by a visiting dietitian |
| T2DM Medical Nutrition Therapy and Text Messages | Experimental | Other: Intervention GroupParticipants 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 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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%.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Control GroupParticipants from the intervention group will receive the usual care over the 6-month intervention period | Other | T2DM Medical Nutrition Therapy |
| Intervention GroupParticipants 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 | Other | T2DM Medical Nutrition Therapy and Text Messages |
Primary outcome
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)
2 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Background: PubMed 24225332Arora 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.
- Background: PubMed 24622367Ramachandran 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Esther Alim Albert contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention Group in people with Type 2 Diabetes Mellitus(T2DM), run by Universiti Malaysia Sabah at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Esther Alim Albert (6088320000, esther_alim_mn22@iluv.ums.edu.my), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06587581, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.