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

The University of Hong Kong282 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

282

Conditions

Pre-diabetes

Interventions

Digital diabetes prevention app interventionBEHAVIORAL

16-week core program consisting of 16 online weekly interactive lessons on diet and physical activity for weight loss. After the completion of the core program, participant can proceed to the 36-week post-core phase. The post-core program provides 8 monthly lessons focusing on maintaining lifestyle habits and weight loss. Participants will be guided to use the smartphone app for goal setting and self-monitoring of diet, physical activity and weight loss. Participants will be demographically matched into online groups of 10-12 persons. Online group discussion board will be set up for participants to discuss goals, share progress and provide supports to each other.

Digital weight loss tracking app interventionBEHAVIORAL

All participants will be provided the same smartphone app as the intervention group for goal setting and self-monitoring of diet, physical activity and weight loss. Participants will be demographically matched into online groups of 10-12 person. Online group discussion board will be set up for participants to discuss goals, share progress and provide supports to each other.

Eligibility

Sex: ALLMin age: 40 YearsMax age: 60 Years

Medical Language ↔ Plain English

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)

Locations (1)

The University of Hong Kong

Hong Kong, Hong Kong

RECRUITING

Outcomes

Primary Outcomes

Percent weight change

% weight change from baseline

Time frame: % weight change at 4 and 12 months from baseline

Secondary Outcomes

Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)

Estimated from fasting insulin and fasting glucose, \[fasting insulin (uU/mL)\*fasting glucose(mmol/L)\]/22.5

Time frame: Changes of insulin sensitivity at 12-months from baseline

Fasting insulin

Fasting insulin in mU/L

Time frame: Changes of fasting insulin to 12-months from baseline

Fasting blood glucose (FG)

Fasting blood glucose in mmol/L \> 8 hours of fasting

Time frame: Changes of FG at 12-months from baseline

Haemoglobin A1C (HbA1C)

HbA1c in %

Time frame: Changes of HbA1c at 4 and 12-months from baseline

Systolic and diastolic blood pressure (SBP, DBP)

in mmHg measured by automatic BP monitor

Time frame: Changes of SBP and DBP to 4 and 12-months from baseline

Blood lipid profile

fasting blood for total cholesterol, HDL, LDL and triglycerides, all in mmol/L

Time frame: Changesof blood lipid at 12-months from baseline

2hr post OGTT glucose (2hr PP)

Blood glucose in mmol/L 2 hours after OGTT

Time frame: Changes of 2hr PP at 12-months from baseline

Central Contacts

Dr Mandy Ho

CONTACT

(+852)39176973 mandyho1@hku.hk

Data from ClinicalTrials.gov

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