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The aim of this study was to investigate the effectiveness of structured lifestyle intervention following a transcultural diabetes nutrition algorithm (tDNA) care compared to usual diabetes care in patients with overweight, obesity and type 2 diabetes (T2D), receiving either the motivational interviewing counseling or conventional counselling technique in an outpatient clinic setting.
The hypothesis is weight loss and glycated haemoglobin (A1C) level will be improved in patients following the tDNA care compared to usual diabetes care and the improvements will be greater in those receiving motivational interviewing counseling than conventional counselling.
The main objective of this study was to investigate the effectiveness of structured lifestyle intervention following a transcultural diabetes nutrition algorithm (tDNA) care compared to usual diabetes care in patients with overweight, obesity and type 2 diabetes (T2D), receiving either the motivational interviewing counseling or conventional counseling technique in an outpatient clinic setting.
The specific objectives are:
Study Design: This is a prospective open-label randomized clinical trial conducted in patients with overweight, obesity and T2D in an outpatient clinic setting.
Study duration: This study was conducted for a period of 12 months consisting of 6 months of intervention phase followed by subsequent 6 months of follow up phase.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| tDNA-MI group | Active Comparator | Follow tDNA intervention and motivational interviewing counselling |
|
| tDNA-CC group | Active Comparator | Follow tDNA intervention and conventional counselling |
|
| UC group | Other | Follow a conventional diet with standard diabetes support and lifestyle education |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tDNA-MI group | Other | tDNA care with structured low calorie meal plan of 1200-1500 kcal/day with conventional foods + 1-2 serving of diabetes specific meal replacements and motivational interviewing counseling. . |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Weight | Anthropometry | 6 months, 12 months |
| Change in Glycated haemoglobin (A1C) | Biochemical measure | 6 months, 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in percentage body fat | Body composition | 6 months |
| Change in fasting blood glucose | Biochemical measure | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Winnie SS Chee, PhD | IMU University, Malaysia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| International Medical University | Kuala Lumpur | 57000 | Malaysia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33253259 | Derived | Gilcharan Singh HK, Chee WSS, Hamdy O, Mechanick JI, Lee VKM, Barua A, Mohd Ali SZ, Hussein Z. Eating self-efficacy changes in individuals with type 2 diabetes following a structured lifestyle intervention based on the transcultural Diabetes Nutrition Algorithm (tDNA): A secondary analysis of a randomized controlled trial. PLoS One. 2020 Nov 30;15(11):e0242487. doi: 10.1371/journal.pone.0242487. eCollection 2020. |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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Randomized controlled Trial
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| tDNA-CC group | Other | tDNA care with structured low calorie meal plan of 1200-1500 kcal/day with conventional foods + 1-2 serving of diabetes specific meal replacements+ 150 min/week of moderate intensity exercise + and conventional counselling. |
|
| UC group | Other | Meal plan of 1200-1500 kcal/day using conventional foods + 150 min/week of moderate intensity exercise + and conventional counselling |
|
| Change in total cholesterol, LDL-C and HDL-C | Biochemical measure | 6 months |
| Change in High sensitivity C-Reactive Protein (HsCRP) | Biochemical measure | 6 months |
| Change in systolic and diastolic blood pressure | Metabolic outcome | 6 months |
| Change in energy intake and macronutrients | Dietary intake | 6 months, 12 months |
| Change in Weight Efficacy Lifestyle (WEL) scores | Eating self efficacy scores ranging from total scores of 0-180, subscales of 0-36. Total scores is a sum of subscales. Higher scores are better. | 6 months, 12 months |
| Change in exercise minutes | Exercise | 6 months, 12 months |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |