Clinical trial NCT03881540: 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
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Obesity
Lead sponsor: International Medical University
Sponsor class: OTHER
First posted: 2019-03-19
Enrollment: 230
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled Trial
Primary purpose: PREVENTION

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:

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.

Eligibility criteria: Inclusion Criteria:

1. Diagnosed with type 2 diabetes mellitus, requiring weight loss
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:

1. Patients whom weight loss might not be safe
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.

Primary outcomes:
measure: Change in Weight
timeFrame: 6 months, 12 months
measure: Change in Glycated haemoglobin (A1C)
timeFrame: 6 months, 12 months
Secondary outcomes:
measure: Change in percentage body fat
timeFrame: 6 months
measure: Change in fasting blood glucose
timeFrame: 6 months
measure: Change in total cholesterol, LDL-C and HDL-C
timeFrame: 6 months
measure: Change in High sensitivity C-Reactive Protein (HsCRP)
timeFrame: 6 months
measure: Change in systolic and diastolic blood pressure
timeFrame: 6 months
measure: Change in energy intake and macronutrients
timeFrame: 6 months, 12 months
measure: Change in Weight Efficacy Lifestyle (WEL) scores
timeFrame: 6 months, 12 months
measure: Change in exercise minutes
timeFrame: 6 months, 12 months
Other outcomes:
Locations:
city: Kuala Lumpur
country: Malaysia
facility: International Medical University
Study officials:
affiliation: International Medical University
name: Winnie SS Chee, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.