Efficacy of tDNA Care on Weight Loss and Metabolic Outcomes in Patients With Overweight, Obesity and Type 2 Diabetes
NCT ID: NCT03881540
Last Updated: 2019-03-22
Study Results
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Basic Information
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COMPLETED
NA
230 participants
INTERVENTIONAL
2014-06-30
2015-12-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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tDNA-MI group
Follow tDNA intervention and motivational interviewing counselling
tDNA-MI 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-CC group
Follow tDNA intervention and conventional counselling
tDNA-CC 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+ 150 min/week of moderate intensity exercise + and conventional counselling.
UC group
Follow a conventional diet with standard diabetes support and lifestyle education
UC group
Meal plan of 1200-1500 kcal/day using conventional foods + 150 min/week of moderate intensity exercise + and conventional counselling
Interventions
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tDNA-MI 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-CC 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+ 150 min/week of moderate intensity exercise + and conventional counselling.
UC group
Meal plan of 1200-1500 kcal/day using conventional foods + 150 min/week of moderate intensity exercise + and conventional counselling
Eligibility Criteria
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Inclusion Criteria
2. Treated with oral hypoglycaemic medications and/or lifestyle modifications
3. Medications have been optimised with no changes in pharmacotherapy in the past three months
4. Aged between 30 to 65 years
5. BMI of \>23 kg/m²
6. A1C between 7% to 9%
7. Failed to achieve HbA1c reduction in the past three months even after seeing a dietitian
8. Willing to comply with study procedures.
Exclusion Criteria
2. Patients diagnosed with type 1 diabetes mellitus and type 2 diabetes mellitus with basal or multiple insulin injections
3. Patients with weight loss exceeding 5 kg in the past three months
4. Patients with current use of medications/meal replacements for weight loss
5. Patients with cancer requiring treatment for the past five years, except of non-melanoma skin cancers or cancers that have been clearly cured
6. Patients with history of bariatric surgery, small bowel resection, or extensive bowel resection
7. 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)
8. Patients receiving chronic treatment with systemic corticosteroids. Use of hormone replacement therapy or oral contraceptives will not lead to exclusion.
9. Patients with renal disease with eGFR \<60 ml/min (based on MDRD) or currently receiving dialysis
10. Patients with chronic alcoholism
11. Patients who are currently pregnant or nursing
12. Patients who plan to relocate where it does not permit full participation in the study.
30 Years
65 Years
ALL
No
Sponsors
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IMU University, Malaysia
OTHER
Responsible Party
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Winnie Chee
Principal Investigator
Principal Investigators
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Winnie SS Chee, PhD
Role: PRINCIPAL_INVESTIGATOR
IMU University, Malaysia
Locations
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International Medical University
Kuala Lumpur, , Malaysia
Countries
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References
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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.
Other Identifiers
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IMU R 134/2014
Identifier Type: -
Identifier Source: org_study_id
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