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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:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Control Group | Other | Participants from the intervention group will receive the usual care over the 6-month intervention period |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Baseline, 3-month, and 6-month |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Esther Alim Albert | Contact | 6088320000 | esther_alim_mn22@iluv.ums.edu.my | |
| Esther Alim Albert | Contact |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ranau District Hospital and Klinik Kesihatan Kundasang | Kota Kinabalu | Sabah | 89308 | Malaysia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24225332 | Background | 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. | |
| 24622367 | Background | 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. |
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| 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 |
|
| 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. | Baseline, 3-month, and 6-month |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
| D008722 | Methods |
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