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

NCT03881540 | Completed

• 1 other identifier: IMU R 134/2014
• Study Type: interventional
• Target: 230
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes; Obesity

Outcome Measures

Primary Outcomes (2)

• Change in Weight

  Anthropometry

  6 months, 12 months

• Change in Glycated haemoglobin (A1C)

  Biochemical measure

  6 months, 12 months

Secondary Outcomes (8)

• Change in percentage body fat

  6 months

• Change in fasting blood glucose

  6 months

• Change in total cholesterol, LDL-C and HDL-C

  6 months

• Change in High sensitivity C-Reactive Protein (HsCRP)

  6 months

• Change in systolic and diastolic blood pressure

  6 months

Study Arms (3)

tDNA-MI group

ACTIVE COMPARATOR

Follow tDNA intervention and motivational interviewing counselling

Other: tDNA-MI group

tDNA-CC group

ACTIVE COMPARATOR

Follow tDNA intervention and conventional counselling

Other: tDNA-CC group

UC group

OTHER

Follow a conventional diet with standard diabetes support and lifestyle education

Other: UC group

Interventions

tDNA-MI group OTHER

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-MI group

tDNA-CC group OTHER

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.

tDNA-CC group

UC group OTHER

Meal plan of 1200-1500 kcal/day using conventional foods + 150 min/week of moderate intensity exercise + and conventional counselling

UC group

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 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.

Sponsors & Collaborators

• IMU University, Malaysia: lead

Study Sites (1)

International Medical University

Kuala Lumpur, 57000, Malaysia

Location

Related Publications (1)

• 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.

  PMID: 33253259 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus; Obesity

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Winnie SS Chee, PhD

  IMU University, Malaysia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized controlled Trial

Study Record Dates

• First Submitted: March 12, 2019
• First Posted: March 19, 2019
• Study Start: June 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: March 22, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)