Efficacy of tDNA Care on Weight Loss and Metabolic Outcomes in Patients With Overweight, Obesity and Type 2 Diabetes

Study Overview
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Brief Summary
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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.

Detailed Description
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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: To compare changes in the primary outcomes (weight, body mass index and A1C) in patients receiving structured lifestyle intervention based on tDNA care compared to usual diabetes care in addition to receiving either the motivational interviewing counseling or conventional counselling techniques at baseline, 6 months and 12 months of intervention. To compare changes in the secondary outcomes (waist circumference, percentage body fat, fasting plasma glucose, lipid profile, high sensitivity-C-Reactive Protein and blood pressure) in patients receiving structured lifestyle intervention based on tDNA care compared to usual diabetes care in addition to receiving either the motivational interviewing counseling or conventional counselling techniques at baseline, and 6 months of intervention. To compare the changes in dietary intake, Weight Efficacy Lifestyle, exercise and physical activity in patients receiving structured lifestyle intervention based on tDNA care compared to usual diabetes care in addition to receiving either the motivational interviewing counseling or conventional counselling techniques at baseline, 6 months and 12 months of intervention. 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.

Official Title
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The Efficacy of a Transcultural Diabetes Nutrition Algorithm (tDNA) Care on Weight Loss and Metabolic Outcomes in Patients With Overweight, Obesity and Type 2 Diabetes in an Outpatient Clinic Setting

Conditions
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Diabetes, Obesity

Intervention / Treatment
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* Other: tDNA-MI group
* Other: tDNA-CC group
* Other: UC group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed with type 2 diabetes mellitus, requiring weight loss Treated with oral hypoglycaemic medications and/or lifestyle modifications Medications have been optimised with no changes in pharmacotherapy in the past three months Aged between 30 to 65 years BMI of >23 kg/m² A1C between 7% to 9% Failed to achieve HbA1c reduction in the past three months even after seeing a dietitian Willing to comply with study procedures. Exclusion Criteria: Patients whom weight loss might not be safe Patients diagnosed with type 1 diabetes mellitus and type 2 diabetes mellitus with basal or multiple insulin injections Patients with weight loss exceeding 5 kg in the past three months Patients with current use of medications/meal replacements for weight loss Patients with cancer requiring treatment for the past five years, except of non-melanoma skin cancers or cancers that have been clearly cured Patients with history of bariatric surgery, small bowel resection, or extensive bowel resection Patients with cardiovascular disease (heart attack or procedure within past three months or participation in cardiac rehabilitation program within last three months, stroke or history/treatment for transient ischaemic attacks in the past three months, or documented history of pulmonary embolus for the past six months) Patients receiving chronic treatment with systemic corticosteroids. Use of hormone replacement therapy or oral contraceptives will not lead to exclusion. Patients with renal disease with eGFR <60 ml/min (based on MDRD) or currently receiving dialysis Patients with chronic alcoholism Patients who are currently pregnant or nursing Patients who plan to relocate where it does not permit full participation in the study.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled Trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: tDNA-MI group<br>Follow tDNA intervention and motivational interviewing counselling | Other: tDNA-MI group<br>* 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. .<br>|
| Active Comparator: tDNA-CC group<br>Follow tDNA intervention and conventional counselling | Other: tDNA-CC group<br>* 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.<br>|
| Other: UC group<br>Follow a conventional diet with standard diabetes support and lifestyle education | Other: UC group<br>* Meal plan of 1200-1500 kcal/day using conventional foods + 150 min/week of moderate intensity exercise + and conventional counselling<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Weight | Anthropometry | 6 months, 12 months | 
| Change in Glycated haemoglobin (A1C) | Biochemical measure | 6 months, 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in percentage body fat | Body composition | 6 months | 
| Change in fasting blood glucose | Biochemical measure | 6 months | 
| 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 |