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

NCT03881540 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 230

Last updated 2019-03-22

No results posted yet for this study

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

Interventions

OTHER

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. .

OTHER

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.

OTHER

UC group

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

Sponsors & Collaborators

  • IMU University, Malaysia

    lead OTHER

Principal Investigators

  • Winnie SS Chee, PhD · IMU University, Malaysia

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-06-30
Primary Completion
2015-12-31
Completion
2015-12-31

Countries

  • Malaysia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03881540 on ClinicalTrials.gov