Obesity Clinical Trial
Official title:
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
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:
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.
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