Pre DiabetesNCT03997656
A Digital Therapy for Diabetes Prevention Among Overweight Adults in Terengganu, Malaysia
A study testing MyDiPP (Malaysia Diabetes Prevention Program) in people with Pre Diabetes and Overweight and Obesity, run by Universiti Sultan Zainal Abidin at 1 site in Malaysia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pre Diabetes, Overweight and Obesity
- What is being tested?
- MyDiPP (Malaysia Diabetes Prevention Program)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Sep 2019to 1 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 12Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
Malaysia1 site, 1 recruiting
- Recruiting
University Sultan Zainal Abidin
Kuala Terengganu, Terengganu, 20050
Sharifah Wajihah Wafa Syed Saadun Tarek Wafa, PhD, 126911510, wajihahwafa@yahoo.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Pre Diabetes, Overweight and Obesity
- Being tested
- MyDiPP (Malaysia Diabetes Prevention Program), usual care
- Medical subject headings
- Glucose Intolerance, Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MyDiPP (Malaysia Diabetes Prevention Program)Behavioural
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.
usual careOther
standard health education from primary care providers in the clinic
| Study group | Role | What they receive |
|---|---|---|
| MyDipp | Experimental | 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. Receives: Behavioral: MyDiPP (Malaysia Diabetes Prevention Program) |
| Control | Other | 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. Receives: Other: usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
body weight
change of the initial body weight by 5% to 7%
Measured: 6-months and 12-months
Secondary outcomes (4)
HbA1c level
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.
Measured: 6-months and 12-months
physical activity level
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.
Measured: 6-months and 12-months
dietary intake
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.
Measured: 6-months and 12-months
health-related quality of life
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).
Measured: 6-months and 12-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2019
- Study start1 Sep 2019 (estimated)
- Primary completion1 May 2020 (estimated)
- Study completion1 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Control group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universiti Sultan Zainal Abidin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sharifah Wajihah Wafa T Syed Saadun Tarek Wafa, PhD, Principal investigator, Universiti Sultan Zainal Abidin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03997656
- Sponsor's protocol ID
- 2018/77
- Status last verified
- Jul 2019
- First submitted
- 21 Jun 2019
- Last updated
- 15 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial of a Digital Therapy for Diabetes Prevention
- ClinicalTrials.gov ID
- NCT03997656
- Acronym / sponsor ID
- 2018/77
- Conditions
- Pre Diabetes, Overweight and Obesity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Universiti Sultan Zainal AbidinUniversity, hospital or other
- Study start
- 1 Sep 2019 (estimated)
- Primary completion
- 1 May 2020 (estimated)
- Study completion
- 1 Jul 2021 (estimated)
- First posted
- 25 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Control group
| Arm | Type | Receives |
|---|---|---|
| MyDipp | Experimental | 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. 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. |
| Control | Other | Other: usual careParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | MyDipp |
| usual carestandard health education from primary care providers in the clinic | Other | Control |
Primary outcome
body weight
Time frame: 6-months and 12-months
change of the initial body weight by 5% to 7%
4 secondary outcomes
HbA1c level
Time frame: 6-months and 12-months
physical activity level
Time frame: 6-months and 12-months
dietary intake
Time frame: 6-months and 12-months
health-related quality of life
Time frame: 6-months and 12-months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sharifah Wajihah Wafa T Syed Saadun Tarek Wafa, PhD principal investigator
Universiti Sultan Zainal Abidin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MyDiPP (Malaysia Diabetes Prevention Program) in people with Pre Diabetes and Overweight and Obesity, run by Universiti Sultan Zainal Abidin at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sharifah Wajihah Wafa Syed Saadun Tarek Wafa, PhD (+60126911510, wajihahwafa@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
body weight (time frame: 6-months and 12-months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2019.