DiabetesNCT03881540

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

A study testing tDNA-MI group, tDNA-CC group and UC group in people with Diabetes and Obesity, run by IMU University, Malaysia at 1 site in Malaysia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 30 to 65 years
Conditions the study is for: Diabetes, Obesity
What is being tested?: tDNA-MI group, tDNA-CC group and UC group
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 230 participants
Where: 1 siteMalaysia
Study dates: Jun 2014to Dec 2015
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 30 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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

Show all 12Show fewer

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.

Trial locations and contacts

1 site in 1 country.

Malaysia1 site

International Medical University
Kuala Lumpur, 57000

Other trials in Malaysia

About this study

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

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.

Read the 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.

Conditions: Diabetes, Obesity
Being tested: tDNA-MI group, tDNA-CC group, UC group
Medical subject headings: Diabetes Mellitus, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

tDNA-MI groupOther
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-CC groupOther
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.
UC groupOther
Meal plan of 1200-1500 kcal/day using conventional foods + 150 min/week of moderate intensity exercise + and conventional counselling

Study groups in NCT03881540
Study group	Role	What they receive
tDNA-MI group	Active comparator	Follow tDNA intervention and motivational interviewing counselling Receives: Other: tDNA-MI group
tDNA-CC group	Active comparator	Follow tDNA intervention and conventional counselling Receives: Other: tDNA-CC group
UC group	Other	Follow a conventional diet with standard diabetes support and lifestyle education Receives: Other: UC group

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Weight
Anthropometry
Measured: 6 months, 12 months
Change in Glycated haemoglobin (A1C)
Biochemical measure
Measured: 6 months, 12 months

Secondary outcomes (8)

Change in percentage body fat
Body composition
Measured: 6 months
Change in fasting blood glucose
Biochemical measure
Measured: 6 months
Change in total cholesterol, LDL-C and HDL-C
Biochemical measure
Measured: 6 months
Change in High sensitivity C-Reactive Protein (HsCRP)
Biochemical measure
Measured: 6 months
Change in systolic and diastolic blood pressure
Metabolic outcome
Measured: 6 months
Change in energy intake and macronutrients
Dietary intake
Measured: 6 months, 12 months
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.
Measured: 6 months, 12 months
Change in exercise minutes
Exercise
Measured: 6 months, 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2014Dec 2015

First posted19 Mar 2019
Study startJun 2014
Primary completionDec 2015
Study completionDec 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for DiabetesStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Model description: Randomized controlled Trial
Masking: None (open label)
Enrolment: 230 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03881540
Sponsor's protocol ID: IMU R 134/2014
Status last verified: Mar 2019
First submitted: 12 Mar 2019
Last updated: 22 Mar 2019
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 33253259

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Diabetes trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT03881540
Acronym / sponsor ID: IMU R 134/2014
Conditions: Diabetes, Obesity
Study type: Interventional
Recruitment status: Completed
Enrolment: 230 participants (actual)
Lead sponsor: IMU University, MalaysiaUniversity, hospital or other
Study start: Jun 2014 (actual)
Primary completion: Dec 2015 (actual)
Study completion: Dec 2015 (actual)
First posted: 19 Mar 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3
Model description: Randomized controlled Trial

Arm	Type	Receives
tDNA-MI group	Active comparator	Other: tDNA-MI groupFollow tDNA intervention and motivational interviewing counselling
tDNA-CC group	Active comparator	Other: tDNA-CC groupFollow tDNA intervention and conventional counselling
UC group	Other	Other: UC groupFollow a conventional diet with standard diabetes support and lifestyle education

Who may qualify

Ages: 30 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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

Key exclusion criteria (12 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
tDNA-MI grouptDNA 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-MI group
tDNA-CC grouptDNA 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	tDNA-CC group
UC groupMeal plan of 1200-1500 kcal/day using conventional foods + 150 min/week of moderate intensity exercise + and conventional counselling	Other	UC group

Primary outcome

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

8 secondary outcomes

Change in percentage body fat
Time frame: 6 months
Change in fasting blood glucose
Time frame: 6 months
Change in total cholesterol, LDL-C and HDL-C
Time frame: 6 months
Change in High sensitivity C-Reactive Protein (HsCRP)
Time frame: 6 months
Change in systolic and diastolic blood pressure
Time frame: 6 months
Change in energy intake and macronutrients
Time frame: 6 months, 12 months
Change in Weight Efficacy Lifestyle (WEL) scores
Time frame: 6 months, 12 months
Change in exercise minutes
Time frame: 6 months, 12 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2019.
Derived from this study: PubMed 33253259Gilcharan 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.
Individual participant dataSharing planned: No

Related trials for Diabetes

Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
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Recruiting
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Recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Winnie SS Chee, PhD principal investigator

IMU University, Malaysia

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing tDNA-MI group, tDNA-CC group and UC group in people with Diabetes and Obesity, run by IMU University, Malaysia at 1 site in Malaysia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Weight (time frame: 6 months, 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03881540, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2019.