A Smartphone-based Intervention for Diabetes Prevention in Overweight Chinese Adults With Pre-diabetes

The University of Hong Kong (HKU)

Status: Enrolling

Conditions: Pre-diabetes

Treatments: Behavioral: Digital weight loss tracking app intervention; Behavioral: Digital diabetes prevention app intervention; Behavioral: Wait-list control (usual care)

Study type: Interventional

Funder types: Other

Identifiers

NCT04875780

HMRF03180248

Details and patient eligibility

About

Type 2 diabetes (T2DM) is a serious chronic condition and one of the world's fastest growing health problems. The onset of T2DM is gradual, with most individuals progressing through a state of pre-diabetes, which provides an important window of opportunity for the prevention of T2DM and its complications. This project aims to translate the evidence-based diabetes prevention strategies into community setting and utilize mobile health technology to reduce diabetes risks in Hong Kong.

Full description

Type 2 diabetes (T2DM) is a major global health issue and the cost to community is high and escalating. The Asia-Pacific region carries a high disease burden, with more than 60% of the global diabetic population living in Asian region. The onset of T2DM is gradual, with most individuals progressing through a state of pre-diabetes. A National Survey conducted in China in 2010 revealed that 50.1% of people aged 18 or older have pre-diabetes. People with pre-diabetes, defined as having impaired fasting glucose (IFG), impaired glucose tolerance (IGT) or elevated glycated haemoglobulin (HbA1C) , are at increased risk of developing T2DM and its associated complications, such as heart diseases and retinopathy, which can develop even in the absence of progression to overt T2DM. Hence, it is essential that people with pre-diabetes are targeted for early intervention to prevent T2DM and related complications.

Obesity is a major risk factor for developing T2DM. International trials demonstrate that lifestyle interventions (which includes diet, physical activity and behavioural modification components) targeting at least 5% weight loss in individuals with pre-diabetes can reduce 3-year diabetes incidence by 58%. Growing evidence suggests that smartphones may be a promising platform for delivery of behavioural lifestyle intervention to achieve weight loss.

This project aims to translate the evidence-based diabetes prevention strategies into community setting and utilize mobile health technology to reduce diabetes risks in Hong Kong.

Enrollment: 282 estimated patients

Sex: All

Ages: 40 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Individuals aged 40 - 60 years old
• Overweight (BMI ≥ 23kg/m2) or obese (BMI ≥ 25 kg/m2)
• With at least one blood test result showing IGT (7.8-11.0 mmol/L after a two-hour glucose tolerance test), IFG (fasting glucose 5.6 - 6.9 mmol/L) or impaired HbA1c 5.7% - 6.4%
• Owns a smartphone
• Able to read Chinese and speak Cantonese.

Exclusion criteria

• With current or clinical history of T2DM, or with co-morbid conditions that may limit participation in the study, such as recent history of an acute cardiovascular event, uncontrolled hypertension, cancer or major psychiatric or cognitive problems
• Already participating in a weight loss programme
• Receiving drug treatment for pre-diabetes or long-term use of medicines known to influence glucose metabolism (e.g. corticosteroids)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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282 participants in 3 patient groups

Digital diabetes prevention app intervention

Experimental group

Description:

Participants will receive web-based diabetes prevention curriculum, virtual social group support and digital tracking via the smartphone app.

Treatment:

Behavioral: Digital diabetes prevention app intervention

Digital weight loss tracking app intervention

Active Comparator group

Description:

Participants will receive the same intervention as the digital diabetes prevention curriculum app group except the web-based diabetes prevention curriculum.

Treatment:

Behavioral: Digital weight loss tracking app intervention

Wait-list control (usual care)

Other group

Description:

Participants will receive usual care in the form of an annual review and blood test, together with general lifestyle advice.

Treatment:

Behavioral: Wait-list control (usual care)