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Trial registered on ANZCTR


Registration number
ACTRN12623000016639
Ethics application status
Approved
Date submitted
4/11/2022
Date registered
10/01/2023
Date last updated
16/01/2024
Date data sharing statement initially provided
10/01/2023
Date results information initially provided
10/01/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effectiveness of problem solving-based lifestyle education on diabetes risk score, and random blood glucose among diabetes high-risk group in Kelantan
Scientific title
Development of problem solving-based lifestyle education and its effectiveness on diabetes risk score, random blood glucose and perception in practicing healthy lifestyle among diabetes high-risk group in Kelantan
Secondary ID [1] 308349 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 diabetes mellitus 328140 0
Prediabetes 328141 0
Condition category
Condition code
Metabolic and Endocrine 325195 325195 0 0
Diabetes
Public Health 325314 325314 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All participants in the intervention group will receive lifestyle educational sessions based on the newly developed module. There were three topics to be covered namely, prediabetes, healthy eating, and being active. The content validation by expert was done and had high content validity index. Similar with high face validation among targeted population. In addition all the topics will be given according to IDEAL model to guide them create their goal to be achieved and options of actions.
I: Identification Problem: After knowledge delivery via lecture, the participants need to identify unhealthy lifestyle as problem that needs to be changed. They will reflect their time of taking the three main meal (breakfast, lunch and dinner) and their weekend/holiday and weekdays physical activity
D: Describe Options: The most relevant and achievable activities will be selected. Small changes every day were encouraged.
Explore Option: The feasibility and barrier of each option were discussed with expert to choose the best options suitable for their daily routine.
A: Act: Participants will practise “Suku Suku Separuh” using the provided Malaysian Healthy Plate to facilitate right portion of foods in every meal and practise continuous walking for 30 minutes duration daily. Step counts will be recorded using the provided smartwatch.
L: Look & Learnt: During following session, the participants will reflect their action, challenges and achievement and share with other participants. New action plans will be discussed with experts to overcome the identified barrier as part of problem-solving skills

The participants must attend at least four sessions on different days within the 8-week program. It will be conducted fortnightly with maximum of five sessions. The sessions will be arranged to accommodate the convenience of group members.

It will be conducted face-to-face session by main researcher and recorded video for refreshment after each session.

Each participant will be given a plate based on the Malaysian Healthy Plate concept. It illustrates a balanced single meal by showing the portion of food that should be consumed daily. It consists of a quarter plate of either carbohydrate such as rice, noodles or bread, quarter plate of protein either fish, poultry, or meat, and half plate of fruits and vegetables. Additionally, plain water is recommended to replace the consumption of sugary drinks. It is also referred to as "Suku-Suku-Separuh" (translated as "Quarter-Quarter-Half"). Each participant will practise right measurement based on Quarter-Quarter-Half concepts by directly measuring the recommended food portion for every mealtime.

Each session will take about 60 – 90 minutes. Then the daily activity will be based on their daily routine, in which practice Quarter Quarter Half approach in three main mealtimes (breakfast, lunch and dinner) and 30 minutes for physical activities, preferable brisk walking.

Each participant will be given a smartwatch that helped them to monitor their daily steps as well as steps in 30 minutes daily as planned

There will be attendance and will be taken in every session. If they missed any session they will be provide a recorded sessions/ hand out or if possible another session will be conducted in a group. Besides that, each participant will be given two checklists for healthy eating and physical activity, known as “Weekly Challenge Form”. Furthermore, they will be encouraged to monitor and practice healthy lifestyle. At the end of the study, the forms will be collected.

This study is a quasi-experimental with control group. Allocation will be done by health clinics in which those attending at Gunong Primary Health Clinic will be allocated to the intervention while participants attending at Pengkalan Kubor Health Clinic will be allocated to the control group. Eligible participants of the community health screening list will be reviewed to identify diabetes high risk individual. All participants who fulfil the operation definition of diabetes high risk individual will be invited.
Intervention code [1] 324798 0
Behaviour
Intervention code [2] 324799 0
Lifestyle
Intervention code [3] 325020 0
Prevention
Comparator / control treatment
The control group follows the standard usual care by the health clinic. This will be done individually upon appointment. Health education will be given individually once for 30 minutes by attending team based on their health status within the period of 8-week as outlined by the standard management of unknown diabetes. The information consists of general health education on managing their health that freely available in website Ministry of Health. The list of consented participants were created.

After completion of outcome data collection at 8 weeks post-enrolment, the participant will be lectures on prediabetes, healthy eating and physical activity of this module.
Control group
Active

Outcomes
Primary outcome [1] 333027 0
Random capillary blood glucose using finger prick glucometer by trained healthcare providers. The blood glucose level was expressed in mmol/L.

The pulp of the index finger is cleaned with cotton soaked in 70% alcohol. A disposable sterile needle is used to puncture the skin and obtain a drop of blood with slight finger pressure. The blood is collected on a glucose test strip (CONTOUR RPlus, Ascensia Diabetes Care UK Limited, England and Wales, EN ISO 15197:2015), which is inserted in the respective glucometer. The blood glucose level is expressed in mmol/L..
Timepoint [1] 333027 0
Baseline, and at 8 weeks post-intervention
Primary outcome [2] 333028 0
The Finnish Diabetes Risk Score (FINDRISC) diabetes risk score
Timepoint [2] 333028 0
The diabetes risk score will be measure using Finnish Diabetes Risk Score (FINDRISC). The data will be taken at pre- (baseline) and post- 8 week intervention, filled up by the researcher.
Primary outcome [3] 333029 0
Perception in practising lifestyle based on MySelf Transformation and Reflection (MySTAR) that consists of five tasks related to healthy lifestyle:
1. Use Malaysian Healthy Plate three times per day
2. Not taking sweet food/drinks
3. Eat fruits and vegetables per daily recommendation
4. Do 150 minutes of moderate intensity exercise a week
5. Do exercise or physical activity regularly at least three times a week.

This inventory was designed specifically for this study.
Timepoint [3] 333029 0
Pre- (baseline) and post- 8 week intervention
Secondary outcome [1] 415577 0
To describe the satisfaction score of problem-solving based lifestyle education among intervention participants. It was designed specifically for this study
Timepoint [1] 415577 0
the data will be collected at post- 8 week intervention.
Secondary outcome [2] 416588 0
Waist circumference measured to the nearest 0.1 cm at midway between the lowest rib and the iliac crest using measuring tape
Timepoint [2] 416588 0
Pre- (Baseline) and post- 8 week intervention
Secondary outcome [3] 416589 0
Blood pressure measured using in sitting position using (Omron HEM-757) after a 10-minute rest. Two measurements of systolic and diastolic blood pressure were taken in a 5-minute interval. The mean of the readings were taken as blood pressure readings.
Timepoint [3] 416589 0
Pre- (Baseline) and post- 8 week intervention
Secondary outcome [4] 416974 0
Height measured to the nearest cm, using a portable SECA Stadiometer 213 with the subject standing erect in light clothing without shoes and socks
Timepoint [4] 416974 0
Pre- (Baseline) and post- 8 week intervention

Eligibility
Key inclusion criteria
1. 18-years or older and Malaysian citizens.
2. Diabetes high-risk adult detected at community health screening.

Diabetes high-risk group is an individual who fulfils at least one of the criteria:
1. Capillary blood glucose (CBG) of greater than 6.5 mmol and less than 7.8 mmol/L during community health screening
2. Confirm not diabetes.
Those who were found to have CBG of > 7.8 mmol/L during community health screening were referred for confirmation of diabetes by venous glucose plasma and MOGTT. Confirmation as not diabetes when:
• Random venous plasma glucose or 2-hour FPG of < 11.1 mmol/L or
• Fasting Plasma Glucose of < 7.0 mmol/L

3. CBG of less than 6.5 mmol/L but FINDRISC diabetes risk score (11 points or higher)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Pregnant
2. Diagnosed by a medical professional with type 2 diabetes mellitus (T2DM) or mental disease

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
23/07/2022
Date of last participant enrolment
Anticipated
Actual
29/10/2022
Date of last data collection
Anticipated
14/01/2023
Actual
12/01/2023
Sample size
Target
80
Accrual to date
Final
80
Recruitment outside Australia
Country [1] 25105 0
Malaysia
State/province [1] 25105 0
Kelantan

Funding & Sponsors
Funding source category [1] 312592 0
Hospital
Name [1] 312592 0
Hospital Universiti Sains Malaysia
Country [1] 312592 0
Malaysia
Primary sponsor type
Individual
Name
Munira binti Hj Mahmud
Address
Department of Community Medicine,
School of Medical Sciences,
Universiti Sains Malaysia Health Campus,
16150 Kubang Kerian, Kelantan
Country
Malaysia
Secondary sponsor category [1] 314205 0
Individual
Name [1] 314205 0
Associate Professor Dr Nor Azwany binti Yaacob
Address [1] 314205 0
Department of Community Medicine
School of Medical Sciences,
Universiti Sains Malaysia Health Campus,
16150 Kubang Kerian, Kelantan
Country [1] 314205 0
Malaysia
Secondary sponsor category [2] 314206 0
Individual
Name [2] 314206 0
Associate Professor Dr Rohana binti Abdul Jalil
Address [2] 314206 0
Department of Community Medicine
School of Medical Sciences,
Universiti Sains Malaysia Health Campus,
16150 Kubang Kerian, Kelantan
Country [2] 314206 0
Malaysia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311918 0
Ministry of Health of Malaysia (Kementerian Kesihatan Malaysia) Medical Research & Ethics Committee
Ethics committee address [1] 311918 0
KEMENTERIAN KESIHATAN MALAYSIA
d/a Kompleks Institut Kesihatan Negara
Blok A, No 1, Jalan Setia Murni U13/52,
Seksyen U13, Bandar Setia Alam,
40170 Shah Alam, Selangor.
Ethics committee country [1] 311918 0
Malaysia
Date submitted for ethics approval [1] 311918 0
01/04/2021
Approval date [1] 311918 0
25/04/2021
Ethics approval number [1] 311918 0
NMRR-21-487-58020 (IIR)
Ethics committee name [2] 311919 0
Human Research Ethics Committee USM (HREC)
Ethics committee address [2] 311919 0
Universiti Sains Malaysia
Kampus Kesihatan
16150 Kubang Kerian, Kelantan, Malaysia.
Ethics committee country [2] 311919 0
Malaysia
Date submitted for ethics approval [2] 311919 0
01/04/2021
Approval date [2] 311919 0
25/04/2021
Ethics approval number [2] 311919 0
USM/JEPeM/21020187

Summary
Brief summary
This is an interventional study for diabetes prevention. Diabetes high risk occurs when blood glucose levels are higher than normal but not high enough to be called diabetes. However, the individuals are more likely to get type 2 diabetes soon or years later and may get heart disease and stroke. Lifestyle modifications are proven to be effective in preventing and delaying the progression of diabetes. Therefore, every individual should receive health education and appropriate techniques for behaviour change, depending on their needs.

The assessment will involve measurement of blood glucose level, diabetes risk assessment, and a self-perception of adopting a healthy lifestyle. A total of 80 diabetes high risk individuals from the districts of Bachok and Tumpat will participate in this study. Both the intervention and control groups will undergo a standard community health screening involving diabetes risk assessment using FINDRISC, blood sugar, and antropometric measurement. The MySelf Transformation and Reflection (MySTAR) perception form pertains to healthy lifestyle practises in terms of nutrition and physical activity. The researchers will review the results of health screening and identify eligible participants.

The study will be conducted for 8-weeks. Those in the intervention group will receive guidance to prevent them from progressing to diabetes. The control group will be introduced to the module after the research is completed. However, the control group will still benefit from standard care during the research period. In addition, they are also provided with pamphlets about various health topics such as general health recommendations during the global pandemic, the standard operating procedures for every clinic visit will be followed. The research team may stop the study or participation at any time. The information that will be gathered from this study will be used to further improve the service provided by government health clinics, especially during community screening.

All the information obtained in this study will be kept and handled in a confidential manner, in accordance with applicable laws and/or regulations. When publishing or presenting the study results, your identity will not be revealed without your express consent. Individuals involved in this study and in your medical care, qualified monitors, and auditors, and governmental or regulatory authorities may inspect and copy your medical records, where appropriate and necessary.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 122834 0
Dr Munira binti Hj Mahmud
Address 122834 0
Department of Community Medicine
School of Medical Sciences, Universiti Sains Malaysia Health Campus, 16150 Kubang Kerian, Kelantan
Country 122834 0
Malaysia
Phone 122834 0
+60133709237
Fax 122834 0
Email 122834 0
muniramahmud@student.usm.my
Contact person for public queries
Name 122835 0
Dr Munira binti Hj Mahmud
Address 122835 0
Department of Community Medicine
School of Medical Sciences, Universiti Sains Malaysia Health Campus, 16150 Kubang Kerian, Kelantan
Country 122835 0
Malaysia
Phone 122835 0
+60133709237
Fax 122835 0
Email 122835 0
muniramahmud@student.usm.my
Contact person for scientific queries
Name 122836 0
Dr Munira binti Hj Mahmud
Address 122836 0
Department of Community Medicine
School of Medical Sciences, Universiti Sains Malaysia Health Campus, 16150 Kubang Kerian, Kelantan
Country 122836 0
Malaysia
Phone 122836 0
+60133709237
Fax 122836 0
Email 122836 0
muniramahmud@student.usm.my

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.