Efficacy of tDNA Care on Weight Loss and Metabolic Outcomes in Patients With Overweight, Obesity and Type 2 Diabetes
Condition: Diabetes; Obesity
MeSH terms: Diabetes Mellitus; Obesity; Overweight; Weight Loss
Study type: Interventional

Summary: 
      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: 
      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:

        1. 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.

        2. 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.

        3. 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.
    

Intervention name(s): tDNA-MI group; tDNA-CC group; UC group
Intervention type(s): Other; Other; Other
Intervention description(s): 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
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized controlled Trial
Masking: None (Open Label)
Primary purpose: Prevention