A Digital Therapy for Diabetes Prevention Among Overweight Adults in Terengganu, Malaysia
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|ClinicalTrials.gov Identifier: NCT03997656|
Recruitment Status : Recruiting
First Posted : June 25, 2019
Last Update Posted : July 15, 2019
|Condition or disease||Intervention/treatment||Phase|
|Pre Diabetes Overweight and Obesity||Behavioral: MyDiPP (Malaysia Diabetes Prevention Program) Other: usual care||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Control group|
|Masking Description:||Single-blinded approach|
|Official Title:||A Randomised Controlled Trial of a Digital Therapy for Diabetes Prevention|
|Estimated Study Start Date :||September 1, 2019|
|Estimated Primary Completion Date :||May 1, 2020|
|Estimated Study Completion Date :||July 1, 2021|
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.
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
- body weight [ Time Frame: 6-months and 12-months ]change of the initial body weight by 5% to 7%
- 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.
- 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.
- 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.
- 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).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03997656
|Contact: Sharifah Wajihah Wafa Syed Saadun Tarek Wafa, PhDfirstname.lastname@example.org|
|University Sultan Zainal Abidin||Recruiting|
|Kuala Terengganu, Terengganu, Malaysia, 20050|
|Contact: Sharifah Wajihah Wafa Syed Saadun Tarek Wafa, PhD 126911510 email@example.com|
|Principal Investigator:||Sharifah Wajihah Wafa T Syed Saadun Tarek Wafa, PhD||Universiti Sultan Zainal Abidin|