None listed
Conditions
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.
Interventions
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: Id
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.
Sponsors
Munira binti Hj Mahmud
Study design
Allocation
Non-randomised trial
Primary purpose
Educational / counselling / training
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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)
Exclusion criteria
1. Pregnant 2. Diagnosed by a medical professional with type 2 diabetes mellitus (T2DM) or mental disease
Outcome results
None listed