Diabetes Prevention and Prediabetes Management in Adult

Not Applicable

Completed

• Conditions: PreDiabetes
• Interventions: Behavioral: Usual care; Behavioral: Digital health supported

• Registration Number: NCT05214209
• Lead Sponsor: Monash University

Brief Summary

Currently, an estimated 3.9 million Malaysians continue to live with diabetes with many more who live with prediabetes. Diabetes was the one of the leading causes of death in the Malaysia and the leading cause for kidney failure, lower-limb amputations, and adult-onset blindness. Heart disease and stroke are two to four times more likely for individuals with diabetes. The use of mHealth or mobile health application can reduce blood sugar among individuals with prediabetes but also prevent a later occurrence of diabetes. In this study, the investigators aim to develop and evaluate the effectiveness of a digital health supported pre-diabetes management program based in an urban community pharmacy setting

Detailed Description

Pre-diabetes is an intermediate state of hyperglycaemia with glycaemic parameters above normal but below the type 2 diabetes mellitus (T2DM) threshold. It was estimated that \>25% of individuals who are pre-diabetic convert to T2DM within 3-5 years and 70% of individuals with pre-diabetes will develop into full-fledge T2DM within their lifetimes. According to the 2017 estimate, the disease burden of pre-diabetes at Western Pacific region was 7.6% (126.7 millions). The situation is more alarming in Malaysia where a national pre-diabetes prevalence of 22.1% was noted. Currently available support and self-care services offered in Public Hospitals such as the Diabetes Mellitus Treatment Adherence Clinics (DMTAC) are managed based on the in-person appointment basis. Most of the clinics are available only in specific locations. The need to travel long distance as well as long waiting hours has deterred the success of the programs. This is particularly true for the urban poor who are less likely to take time off from work than those from the higher income group. It is also noteworthy to state that the management program when available, generally target the diagnosed T2DM patients.

Studies have shown that individuals with pre-diabetes can substantially reduce their risk of progression to T2DM via participation in evidence-based lifestyle change programs. Previous reports have recorded 54-58% reduction in risk for development to T2DM over 1-3 years with the protective benefit persisting up to 10 years following completion of the program. However, there are several considerations when implementing effective lifestyle intervention program among the pre-diabetes populations in Malaysia. The intervention program should easily be accessible and not confined to public primary and secondary healthcare centres which are already suffering from an overcapacity. Furthermore, consultation should be provided by properly trained healthcare professionals while the ease of communication between the patients and the "lifestyle coach" should be made available.

The advancement of information technology coupled with the increasing availability and acceptance of internet and mobile devices provide useful opportunities for application of wireless and mobile technology in order to enhance self-management of chronic conditions. The incorporation of digital technologies can improve patient adherence and facilitate real-time monitoring of vital biological measurements (i.e. via wearable). Additionally, the "mobile health" (mHealth) services are easily scalable, thus providing opportunities to a greater public accessibility and narrow the disparity in access to disease management. In this study, the investigators propose to pilot a digital health supported pre-diabetes management program based in an urban community pharmacy setting

Study Timeline

• Study First Submitted: 2021-12-15
• Study First Submitted QC: 2022-01-14
• Study First Posted: 2022-01-28
• Study Start: 2022-03-01
• Primary Completion: 2024-11-30
• Study Completion: 2024-12-31
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-05
• Last Update Posted: 2025-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Aged 18 years and above
• BMI 23 and above
• HbA1c 5.7 - 6.3%

Exclusion Criteria

• Unable to give informed consent
• Pregnant or lactating
• Established diabetes
• Terminal illness
• Does not own a mobile phone
• Plans to relocate to an area or travel plans that do not permit full participation in the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual care arm	Usual care	The control group will be a "usual care" condition in which participants are free to seek any assistance for their medical care during the study period. Participants will be given physical tracking sheets to record their food intake, weight, steps and exercises.
Intervention arm	Digital health supported	Participants receiving the phone app together with a fitness tracker. All participants will receive the educational curriculum over a period of 4 weeks through the app. The mobile app allows secure patient monitoring through a participant dashboard that the coach can use to increase patient adherence and motivation to achieve goals. The participant can use the app to log their food intake, weight, steps, exercise, in addition to participating in the peer support via the chat function. Participants will also receive regular care and follow up in community pharmacies for support.

Primary Outcome Measures

Name	Time	Method
Acceptability of mobile app assessed by a semi-structured interview	1 month	Semi-structured interview focusing on users experience will be conducted post-intervention.
Feasibility of mobile app assessed by the engagement rate with the mobile app	1 month	Engagement rate with the mobile app will be measured via time spend on using the app functions, measured in hours.

Secondary Outcome Measures

Name	Time	Method
Change in body fat composition	Baseline, 1 month	Body fat composition change measured in % change.
Change in health related quality of life as accessed by EuroQol (EQ-5D-5L)	Baseline, 1 month	The questionnaire assess patient's health state in 5 dimensions- anxiety/depression, mobility, self-care, usual activities, pain/discomfort. Each dimension can be scored from 1 - 5, summing up to a total score of between 5 - 25. A lower score representing a better health state.
Change in weight	Baseline, 1 month	Weight Loss by % of change and total weight change (kg).
Change in physical activity	Baseline, 1 month	Physical Activity Questionnaire (short form) (IPAQ) to obtain internationally comparable data on health-related physical activity. Time spent on physical activities will be measured and converted into metabolic equivalent for task (MET). A lower MET indicates a lower physical activity level.
Change in lipid profile	Baseline, 1 month	HDL, LDL, triglycerides and total cholesterol levels will be collected, unit in mmol/L
Change in dietary practice	Baseline, 1 month	3-Day diet recall to assess changes in food intake
Change in waist-to-hip ratio	Baseline, 1 month	Waist circumference and hip circumference measured in centimetres.
Change in blood pressure	Baseline, 1 month	Systolic and diastolic pressures will be collected during the study period, unit in mmHg
Change in knowledge, attitude and practice towards prediabetes	Baseline, 1 month	Knowledge Attitude Practice-Prediabetes Assessment Questionnaire (KAP-PAQ) questionnaire will be administered pre- and post intervention. The minimum total score is 14 while the maximum total score is 91. A higher score indicating a better knowledge, attitude and practice.

Trial Locations

Locations (1)

School of Pharmacy; 🇲🇾 Subang Jaya, Selangor, Malaysia