An interventional study of tDNA-MI group and tDNA-CC group in Diabetes and Obesity, sponsored by International Medical University. Completed at 1 site in Malaysia. Open to participants aged 30 Years to 65 Years. Per ClinicalTrials.gov, last updated 2019-03-22.
Sponsored by International Medical University · Not applicable, Interventional, and Prevention
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.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 230 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →International Medical University is the lead sponsor of 11 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Follow tDNA intervention and motivational interviewing counselling
Other: tDNA-MI group
Follow tDNA intervention and conventional counselling
Other: tDNA-CC group
Follow a conventional diet with standard diabetes support and lifestyle education
Other: UC group
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. .
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.
Meal plan of 1200-1500 kcal/day using conventional foods + 150 min/week of moderate intensity exercise + and conventional counselling
Change in Weight
Anthropometry
Time frame: 6 months, 12 months
Change in Glycated haemoglobin (A1C)
Biochemical measure
Time frame: 6 months, 12 months
Change in percentage body fat
Body composition
Time frame: 6 months
Change in fasting blood glucose
Biochemical measure
Time frame: 6 months
Change in total cholesterol, LDL-C and HDL-C
Biochemical measure
Time frame: 6 months
Change in High sensitivity C-Reactive Protein (HsCRP)
Biochemical measure
Time frame: 6 months
Change in systolic and diastolic blood pressure
Metabolic outcome
Time frame: 6 months
Change in energy intake and macronutrients
Dietary intake
Time frame: 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.
Time frame: 6 months, 12 months
Change in exercise minutes
Exercise
Time frame: 6 months, 12 months
Plan to share: No
This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
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International Medical University