- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03997656
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
Unknown
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Anticipated)
100
Phase
- 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
- Name: Sharifah Wajihah Wafa Syed Saadun Tarek Wafa, PhD
- Phone Number: +60126911510
- Email: wajihahwafa@yahoo.com
Study Locations
-
-
Terengganu
-
Kuala Terengganu, Terengganu, Malaysia, 20050
- Recruiting
- University Sultan Zainal Abidin
-
Contact:
- Sharifah Wajihah Wafa Syed Saadun Tarek Wafa, PhD
- Phone Number: 126911510
- Email: wajihahwafa@yahoo.com
-
-
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
Ages Eligible for Study
16 years to 63 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 |
Intervention / Treatment |
---|---|
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.
|
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.
|
standard health education from primary care providers in the clinic
|
What is the study measuring?
Primary Outcome Measures
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
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
Investigators
- 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)
September 1, 2019
Primary Completion (Anticipated)
May 1, 2020
Study Completion (Anticipated)
July 1, 2021
Study Registration Dates
First Submitted
June 21, 2019
First Submitted That Met QC Criteria
June 24, 2019
First Posted (Actual)
June 25, 2019
Study Record Updates
Last Update Posted (Actual)
July 15, 2019
Last Update Submitted That Met QC Criteria
July 11, 2019
Last Verified
July 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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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