Diabetes Prevention and Prediabetes Management in Adult

NCT05214209 | Completed

• 1 other identifier: PRIME (pilot)
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Conditions

PreDiabetes

Keywords

Digital Health; Mobile Health; Lifestyle Program; Prediabetes

Outcome Measures

Primary Outcomes (2)

• Feasibility of mobile app assessed by the engagement rate with the mobile app

  Engagement rate with the mobile app will be measured via time spend on using the app functions, measured in hours.

  1 month

• Acceptability of mobile app assessed by a semi-structured interview

  Semi-structured interview focusing on users experience will be conducted post-intervention.

  1 month

Secondary Outcomes (9)

• Change in health related quality of life as accessed by EuroQol (EQ-5D-5L)

  Baseline, 1 month

• Change in dietary practice

  Baseline, 1 month

• Change in physical activity

  Baseline, 1 month

• Change in blood pressure

  Baseline, 1 month

• Change in lipid profile

  Baseline, 1 month

Study Arms (2)

Intervention arm

EXPERIMENTAL

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.

Behavioral: Digital health supported

Usual care arm

ACTIVE COMPARATOR

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.

Behavioral: Usual care

Interventions

Digital health supported BEHAVIORAL

Participants will be issued a fitness tracker, a Bluetooth enabled glucometer, and a custom developed app which they can communicate digitally to the study investigators either as a group or individually. In the beginning of the study, participants will be taught on how to use the program, how to interact with their coach, and the importance of maintaining motivation throughout the program. Participants will have access to a pharmacist-participant messaging, group messaging, daily challenges for behavior change, education articles (weekly bite-sized content over 4 weeks), food logging, steps and exercise logging, and feedback. They will be asked to log their weight, meals, and physical activity within the program on a weekly basis. Pharmacist will monitor participant progress through a web-based dashboard. Community pharmacist will be assisting users in setting specific, measurable, attainable, realistic, and time-based goals on a weekly basis.

Intervention arm

Usual care BEHAVIORAL

Participants will be issued a fitness tracker and Bluetooth enabled glucometer but these functions will not be enabled or linked to any app. All participants will be given physical tracking sheets to log in their food intake, blood glucose levels and food diary but will not have access to a personal coaching. Participants are free to seek any assistance for their medical care during the study period.

Usual care arm

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Monash University: lead
• Caring Pharmacy: collaborator
• Bionime Corporation: collaborator

Study Sites (1)

School of Pharmacy

Subang Jaya, Selangor, 47500, Malaysia

Location

MeSH Terms

Conditions

Prediabetic State

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Shaun Lee, PhD

  Monash University Malaysia

  PRINCIPAL INVESTIGATOR

• Chun Wie Chong, PhD

  Monash University Malaysia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Cluster randomisation with blinding of statisticians
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 15, 2021
• First Posted: January 28, 2022
• Study Start: March 1, 2022
• Primary Completion: November 30, 2024
• Study Completion: December 31, 2024
• Last Updated: May 8, 2025

Record last verified: 2025-05

Locations

MY (1)