Efficacy of tDNA Care on Weight Loss and Metabolic Outcomes in Patients With Overweight, Obesity and Type 2 Diabetes
Primary Purpose
Diabetes, Obesity
Status
Completed
Phase
Not Applicable
Locations
Malaysia
Study Type
Interventional
Intervention
tDNA-MI group
tDNA-CC group
UC group
Sponsored by
About this trial
This is an interventional prevention trial for Diabetes
Eligibility Criteria
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.
Sites / Locations
- International Medical University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Other
Arm Label
tDNA-MI group
tDNA-CC group
UC group
Arm Description
Follow tDNA intervention and motivational interviewing counselling
Follow tDNA intervention and conventional counselling
Follow a conventional diet with standard diabetes support and lifestyle education
Outcomes
Primary Outcome Measures
Change in Weight
Anthropometry
Change in Glycated haemoglobin (A1C)
Biochemical measure
Secondary Outcome Measures
Change in percentage body fat
Body composition
Change in fasting blood glucose
Biochemical measure
Change in total cholesterol, LDL-C and HDL-C
Biochemical measure
Change in High sensitivity C-Reactive Protein (HsCRP)
Biochemical measure
Change in systolic and diastolic blood pressure
Metabolic outcome
Change in energy intake and macronutrients
Dietary intake
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.
Change in exercise minutes
Exercise
Full Information
NCT ID
NCT03881540
First Posted
March 12, 2019
Last Updated
March 20, 2019
Sponsor
International Medical University
1. Study Identification
Unique Protocol Identification Number
NCT03881540
Brief Title
Efficacy of tDNA Care on Weight Loss and Metabolic Outcomes in Patients With Overweight, Obesity and Type 2 Diabetes
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
June 2014 (Actual)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
International Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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:
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Obesity
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled Trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
230 (Actual)
8. Arms, Groups, and Interventions
Arm Title
tDNA-MI group
Arm Type
Active Comparator
Arm Description
Follow tDNA intervention and motivational interviewing counselling
Arm Title
tDNA-CC group
Arm Type
Active Comparator
Arm Description
Follow tDNA intervention and conventional counselling
Arm Title
UC group
Arm Type
Other
Arm Description
Follow a conventional diet with standard diabetes support and lifestyle education
Intervention Type
Other
Intervention Name(s)
tDNA-MI group
Intervention Description
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. .
Intervention Type
Other
Intervention Name(s)
tDNA-CC group
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
UC group
Intervention Description
Meal plan of 1200-1500 kcal/day using conventional foods + 150 min/week of moderate intensity exercise + and conventional counselling
Primary Outcome Measure Information:
Title
Change in Weight
Description
Anthropometry
Time Frame
6 months, 12 months
Title
Change in Glycated haemoglobin (A1C)
Description
Biochemical measure
Time Frame
6 months, 12 months
Secondary Outcome Measure Information:
Title
Change in percentage body fat
Description
Body composition
Time Frame
6 months
Title
Change in fasting blood glucose
Description
Biochemical measure
Time Frame
6 months
Title
Change in total cholesterol, LDL-C and HDL-C
Description
Biochemical measure
Time Frame
6 months
Title
Change in High sensitivity C-Reactive Protein (HsCRP)
Description
Biochemical measure
Time Frame
6 months
Title
Change in systolic and diastolic blood pressure
Description
Metabolic outcome
Time Frame
6 months
Title
Change in energy intake and macronutrients
Description
Dietary intake
Time Frame
6 months, 12 months
Title
Change in Weight Efficacy Lifestyle (WEL) scores
Description
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
Title
Change in exercise minutes
Description
Exercise
Time Frame
6 months, 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Winnie SS Chee, PhD
Organizational Affiliation
International Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
International Medical University
City
Kuala Lumpur
ZIP/Postal Code
57000
Country
Malaysia
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33253259
Citation
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.
Results Reference
derived
Learn more about this trial
Efficacy of tDNA Care on Weight Loss and Metabolic Outcomes in Patients With Overweight, Obesity and Type 2 Diabetes
We'll reach out to this number within 24 hrs