Efficacy of tDNA Care on Weight Loss and Metabolic Outcomes in Patients With Overweight, Obesity and Type 2 Diabetes

Not Applicable

Completed

• Conditions: Obesity; Diabetes
• Interventions: Other: UC group; Other: tDNA-CC group; Other: tDNA-MI group

• Registration Number: NCT03881540
• Lead Sponsor: International Medical University

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.

Study Timeline

• Study Start: 2014-06
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2019-03
• Study First Submitted: 2019-03-12
• Study First Submitted QC: 2019-03-16
• Study First Posted: 2019-03-19
• Last Update Submitted: 2019-03-20
• Last Update Posted: 2019-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 230

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
UC group	UC group	Follow a conventional diet with standard diabetes support and lifestyle education
tDNA-CC group	tDNA-CC group	Follow tDNA intervention and conventional counselling
tDNA-MI group	tDNA-MI group	Follow tDNA intervention and motivational interviewing counselling

Primary Outcome Measures

Name	Time	Method
Change in Glycated haemoglobin (A1C)	6 months, 12 months	Biochemical measure
Change in Weight	6 months, 12 months	Anthropometry

Secondary Outcome Measures

Name	Time	Method
Change in fasting blood glucose	6 months	Biochemical measure
Change in total cholesterol, LDL-C and HDL-C	6 months	Biochemical measure
Change in percentage body fat	6 months	Body composition
Change in exercise minutes	6 months, 12 months	Exercise
Change in energy intake and macronutrients	6 months, 12 months	Dietary intake
Change in systolic and diastolic blood pressure	6 months	Metabolic outcome
Change in Weight Efficacy Lifestyle (WEL) scores	6 months, 12 months	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 High sensitivity C-Reactive Protein (HsCRP)	6 months	Biochemical measure

Trial Locations

Locations (1)

International Medical University; 🇲🇾 Kuala Lumpur, Malaysia