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

NCT03997656 | Unknown

• 1 other identifier: 2018/77
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Pre Diabetes; Overweight and Obesity

Outcome Measures

Primary Outcomes (1)

• body weight

  change of the initial body weight by 5% to 7%

  6-months and 12-months

Secondary Outcomes (4)

• HbA1c level

  6-months and 12-months

• physical activity level

  6-months and 12-months

• dietary intake

  6-months and 12-months

• health-related quality of life

  6-months and 12-months

Study Arms (2)

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.

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.

Other: usual care

Interventions

MyDiPP (Malaysia Diabetes Prevention Program) BEHAVIORAL

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.

MyDipp

usual care OTHER

standard health education from primary care providers in the clinic

Control

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Universiti Sultan Zainal Abidin: lead

Study Sites (1)

University Sultan Zainal Abidin

Kuala Terengganu, Terengganu, 20050, Malaysia

RECRUITING

MeSH Terms

Conditions

Glucose Intolerance; Overweight; Obesity

Condition Hierarchy (Ancestors)

Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Sharifah Wajihah Wafa T Syed Saadun Tarek Wafa, PhD

  Universiti Sultan Zainal Abidin

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sharifah Wajihah Wafa Syed Saadun Tarek Wafa, PhD

CONTACT

+60126911510; wajihahwafa@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Single-blinded approach
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Control group

Study Record Dates

• First Submitted: June 21, 2019
• First Posted: June 25, 2019
• Study Start: September 1, 2019
• Primary Completion: May 1, 2020
• Study Completion: July 1, 2021
• Last Updated: July 15, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)