A Digital Therapy for Diabetes Prevention Among Overweight Adults in Terengganu, Malaysia

July 11, 2019 updated by: Universiti Sultan Zainal Abidin

A Randomised Controlled Trial of a Digital Therapy for Diabetes Prevention

The modern world revolves around technology; unsurprisingly companies are leveraging the expertise of the digital tech industry to aid in the prevention of chronic diseases. Among one of the most common chronic diseases in Malaysia is diabetes. Prevalence of diabetes in Malaysia has increased by more than two folds over the past two decades. Despite a growing number of tech products developments on diabetes prevention, a recent meta-analysis has found almost no evidence on digital therapy outside the developed world. Therefore, this study is needed to demonstrate the potential of digital therapy in preventing diabetes in Malaysia. The study design is a randomized controlled trial study conducted in Kuala Terengganu, Malaysia. The study will be conducted in two phases. The first phase will involve preparation of intervention modules and development of intervention mobile app. The second phase will involve validation and utilization of the digital therapy. We hope that this digital therapy program can make a significant difference in health outcomes, especially for diabetes. By giving precise regimes and daily monitoring, digital therapeutics can offer mountains of data that can potentially provide doctors unprecedented insights into patient behavior and create feedback or optimization loops for individual patients. Enabling patients to take greater control over managing their chronic illnesses and preventing disease progression could save billions of ringgits throughout the entire Malaysia healthcare system. By that, we hope this approach can be considered as a scalable solution to address national diabetes prevention efforts to target of improvement on diabetes prevalence to not more than 15% by 2025 and serve as a model for applying such services to other chronic diseases.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Digital therapy is a new field that has emerged as the evidence-based treatments from the field of behavioural medicine that are delivered online. It is considered as a scalable method to reach a large number of at-risk population, convenient and accessible. Furthermore, it frees participants from the requirement of travelling to a specific location and more flexible with the time to participate. The aim of this study therefore to determine the feasibility and efficacy of a lifestyle intervention for type 2 diabetes prevention in adults at risk of developing diabetes, an assessor-blinded, parallel-group, randomised controlled trial using the MyDiPP (Malaysia Diabetes Prevention Programme) app. Eligible participants were stratified (age, BMI) and then randomised in a 1:1 ratio to either the 12-month MyDiPP intervention or receive standard health education from primary care providers in the clinic. The study will be conducted in two phases. The first phase will involve preparation of intervention modules, development of intervention mobile app, training and recruitment of participants. The second phase of the study will involve implementation of the intervention, data collection, follow up and data analyses. The study will be conducted in individuals aged 18- to 65-years old, living, working or studying in Kuala Terengganu who is at risk developing diabetes but currently does not have diabetes recruited through online advertisement. The target population is adult residents that lived, worked or studied in Kuala Terengganu who is identified as being at high risk of type 2 diabetes. One hundred participants will be recruited for this study. They will be identified by a two-stage screening process. In the first stage, patients at high risk of type 2 diabetes will be identified via the CDC Diabetes Risk Test that will be distributed via Google Form. The researcher will invite those who scored ≥5 for second stage screening test via the HbA1c test. In the second stage, patients attending a screening for eligibility who have a current HbA1c in the range 38-44 mmol/mol or 5.6-6.2% will be invited to volunteer.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Sharifah Wajihah Wafa Syed Saadun Tarek Wafa, PhD
  • Phone Number: +60126911510
  • Email: wajihahwafa@yahoo.com

Study Locations

  • Malaysia
    • Terengganu
      • Kuala Terengganu, Terengganu, Malaysia, 20050
        • Recruiting
        • University Sultan Zainal Abidin
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • aged 18-65 years old
  • body mass index (BMI) of ≥23 kg/m2,
  • high risk for diabetes (diabetes risk test score ≥5 [22] or HbA1c of 38-44 mmol/mol or 5.6-6.2%
  • ownership of a smartphone (Android only) for communication defined as logging on at least once/day to the internet
  • being fluent in Malay or English languages and
  • had no contradictions to participate in weight management program or physical activity.

Exclusion Criteria:

  • clinical history of diabetes or newly diagnosed diabetes at the time of screening where HbA1c level ≥45 mmol/mol or ≥6.3%
  • taking oral anti-diabetic agents
  • participating in a concurrent weight management program or interventional research protocol
  • on a prescribed medical diet, anti-obesity or diabetes therapy within the preceding 4 months
  • had clinical history of cardiovascular diseases occurred within the past 6 months
  • any form of cancers that require treatment
  • dementia or probable Alzheimer's disease
  • advanced arthritis
  • pregnant or within 6 weeks of having given birth or planning to become pregnant in the next 12 months
  • existing liver and renal disease and having hyperthyroidism
  • any mental health condition including eating disorder or alcohol/substance use
  • other causes which could interfere with participation (for examples physically disabled)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: MyDipp
The participants will go through 16-weekly core lessons that need to be completed within the first 24 weeks after randomisation focusing on changing dietary habits, increase physical activity and relapse prevention and 6-monthly post-core lessons focusing on maintenance of lifestyle habits and weight loss achieved during the core program. Each lesson will take 30 to 60 minutes to complete. The lesson will be considered complete if the participants clicked through all of the pages and answered multiple choice questions to indicate engagement and understanding.
Behavioral: MyDiPP (Malaysia Diabetes Prevention Program)
The participants will go through 16-weekly core lessons that need to be completed within the first 24 weeks after randomisation focusing on changing dietary habits, increase physical activity and relapse prevention and 6-monthly post-core lessons focusing on maintenance of lifestyle habits and weight loss achieved during the core program.
Other: Control
Participants in the control group (usual care) will receive standard health education from primary care providers in the clinic. In addition, they also will be provided with pamphlets and booklets about various health topics. They will be given a diary to record their weights, diet, physical activities and blood test result.
Other: usual care
standard health education from primary care providers in the clinic

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
body weight
Time Frame: 6-months and 12-months
change of the initial body weight by 5% to 7%
6-months and 12-months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
HbA1c level
Time Frame: 6-months and 12-months
HbA1c level will be tested using A1CNow+ test kit from a finger-stick blood samples collected in a capillary tube according to the manufacturer's procedure guidelines. To measure HbA1c with A1cNow+ test kit, the finger will be cleaned with alcohol swab, allowed to dry and then lanced with sterile lancet to obtain a drop of blood. A 5µl capillary blood sample will be collected and added to the sample dilution buffer. The diluted sample will be mixed and added to the monitoring using transfer pipette. Once the sample was applied, the monitor will begin the analyses. Digital results will be displayed in the display window after 5 minutes. The test result will be recorded for each participant.
6-months and 12-months
physical activity level
Time Frame: 6-months and 12-months
Physical activity (PA) will be assessed using translated and validated version of short-form International Physical Activity Questionnaire (IPAQ short form). It comprises of seven items that identify frequency and time spent on three specific types of physical activity (walking, moderate intensity activity, and vigorous intensity activity) during the past seven days. The Metabolic Equivalent (MET) values will be measured. The subjects' total physical activity (MET-minutes/week) will be calculated by summing up the walking, moderate and vigorous intensity activity scores. Subjects will be categorised as "active" if they achieved ≥600 MET-minutes/week, "moderately active" if they achieved ≥150 MET-minutes/week and "inactive" if they achieved <150 MET-minutes/week.
6-months and 12-months
dietary intake
Time Frame: 6-months and 12-months
The dietary intake status of the participants will be assessed from their food diary record from the app and the diary for intervention and control participants respectively. Participants will be asked to record their dietary intake for three days (two weekdays and one weekend) and the average measurement will be taken. A dietary analysis software, Nutritionist Pro Inc. will be used for energy and nutrient analysis.
6-months and 12-months
health-related quality of life
Time Frame: 6-months and 12-months
HRQoL will be assessed using translated and validated version of SF-36 health survey questionnaire. It comprises of 36 items which measure eight health domains which are physical functioning (PF), role-physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role-emotion (RE) and mental health (MH). The eight domains will be scored from 0 to 100 indicating worst to best possible health. All the scores will be further summarised into the Physical Component Summary score (PCS) and the Mental Component Summary score (MCS).
6-months and 12-months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universiti Sultan Zainal Abidin

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sharifah Wajihah Wafa T Syed Saadun Tarek Wafa, PhD, Universiti Sultan Zainal Abidin

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2019

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 21, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 24, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 25, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 15, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 11, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2018/77

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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