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

Not Applicable

• Conditions: Pre-diabetes
• Interventions: Behavioral: Digital diabetes prevention app intervention; Behavioral: Wait-list control (usual care); Behavioral: Digital weight loss tracking app intervention

• Registration Number: NCT04875780
• Lead Sponsor: The University of Hong Kong

Brief Summary

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.

Detailed 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-05-01
• Study First Submitted QC: 2021-05-01
• Study First Posted: 2021-05-06
• Study Start: 2021-06-01
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-16
• Last Update Posted: 2021-10-25
• Primary Completion: 2024-05-31
• Study Completion: 2024-05-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 282

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.

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Digital diabetes prevention app intervention	Digital diabetes prevention app intervention	Participants will receive web-based diabetes prevention curriculum, virtual social group support and digital tracking via the smartphone app.
Wait-list control (usual care)	Wait-list control (usual care)	Participants will receive usual care in the form of an annual review and blood test, together with general lifestyle advice.
Digital weight loss tracking app intervention	Digital weight loss tracking app intervention	Participants will receive the same intervention as the digital diabetes prevention curriculum app group except the web-based diabetes prevention curriculum.

Primary Outcome Measures

Name	Time	Method
Percent weight change	% weight change at 4 and 12 months from baseline	% weight change from baseline

Secondary Outcome Measures

Name	Time	Method
Haemoglobin A1C (HbA1C)	Changes of HbA1c at 4 and 12-months from baseline	HbA1c in %
Systolic and diastolic blood pressure (SBP, DBP)	Changes of SBP and DBP to 4 and 12-months from baseline	in mmHg measured by automatic BP monitor
Blood lipid profile	Changesof blood lipid at 12-months from baseline	fasting blood for total cholesterol, HDL, LDL and triglycerides, all in mmol/L
Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)	Changes of insulin sensitivity at 12-months from baseline	Estimated from fasting insulin and fasting glucose, \[fasting insulin (uU/mL)\*fasting glucose(mmol/L)\]/22.5
Fasting insulin	Changes of fasting insulin to 12-months from baseline	Fasting insulin in mU/L
2hr post OGTT glucose (2hr PP)	Changes of 2hr PP at 12-months from baseline	Blood glucose in mmol/L 2 hours after OGTT
Fasting blood glucose (FG)	Changes of FG at 12-months from baseline	Fasting blood glucose in mmol/L \> 8 hours of fasting
Health-related quality of life (HRQOL) as assessed by SF12	Changes in HRQOL from baseline to 4 and 12-months	12-item Short Form Survey (SF12 Chinese version). It is a validated scale which provides two summary measures.; Physical and Mental Health Composite Scores (PCS \& MCS) will be computed using the scores of 12 questions and range from 0 to 100. Higher scores represent better health.
Smartphone apps user engagement	At 12-months follow-up	User's overall login frequency and duration to the app and login frequency and duration to each module, as well as the frequency of participation in the group sharing and discussion. Usage data will be obtained from the apps administrative portal.
Dietary intake as assessed by 24-hour recall	Changes in dietary intake from baseline to 4 and 12-months	24-hour food recall
Central obesity	Changes of waist circumference at 12-months from baseline	Waist circumference in cm
User feedback as assessed by an online exit questionnaire	At 12-months follow-up	An online exit questionnaire will be administered to participants in the intervention group at 12 months.
Physical activity as assessed by IPAQ	Change in levels of physical activity from baseline to 4 and 12-months	International physical activity questionnaire short form (IPAQ, Chinese version). A validated 6-item questionnaire to assess the frequency and duration of vigorous intensity activity, moderate intensity activity, and walking. The questionnaire will be scored using established methods (www.ipaq.ki.se). Data will be summarized to report physical activity in categories: 1. High-active group; * Vigorous-intensity activity on ≥ 3 days and accumulating ≥1500 MET-minutes/week OR; * ≥7 days of any combination of walking, moderate-intensity or vigorous intensity activities achieving ≥3000 MET-minutes/week; 2. Moderate-active group; * ≥3 days of vigorous activity of ≥20 minutes/day OR; * ≥5 days of moderate-intensity activity or walking of ≥30 minutes/day OR; * ≥5 days of any combination of walking, moderate-intensity or vigorous intensity activities achieving ≥600 MET-min/week.; 3. Low-active/inactive group Individuals who do not meet criteria for high- and moderate-active
Percentage body fat as assessed by BIA	Changes of body fat at 12-months from baseline	Bioelectrical impedance analysis measuring body fat in %

Trial Locations

Locations (1)

The University of Hong Kong; 🇭🇰 Hong Kong, Hong Kong