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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effects of a Smartphone-based Weight Loss Programme Targeting Chinese Overweight Adults With Pre-diabetes: A Randomized Controlled Trial

Conditions
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Pre-diabetes

Intervention / Treatment
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* Behavioral: Digital diabetes prevention app intervention
* Behavioral: Digital weight loss tracking app intervention
* Behavioral: Wait-list control (usual care)


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: It is a 12-month 3-arm randomised controlled trial, RCT (the digital diabetes prevention app group, the digital weight loss tracking app group, and the wait-list usual care group). The digital diabetes prevention app group will receive these intervention components: web-based diabetes prevention curriculum, virtual social group support, goal setting and self-monitoring via the smartphone app. The digital weight loss tracking group will receive digital tracking of weight loss, diet and physical activity and virtual social support group function (mimicking the publically available weight loss apps), but without the web-based diabetes prevention curriculum. The wait-list usual care group will receive usual care in the form of an annual review and blood test, together with general lifestyle advice at our NGO collaborator's (UCN) community clinics.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Digital diabetes prevention app intervention<br>Participants will receive web-based diabetes prevention curriculum, virtual social group support and digital tracking via the smartphone app. | Behavioral: Digital diabetes prevention app intervention<br>* 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.<br>* Other names: Virtual social support group;|
| Active Comparator: Digital weight loss tracking app intervention<br>Participants will receive the same intervention as the digital diabetes prevention curriculum app group except the web-based diabetes prevention curriculum. | Behavioral: Digital weight loss tracking app intervention<br>* 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.<br>* Other names: Virtual social support group;|
| Other: Wait-list control (usual care)<br>Participants will receive usual care in the form of an annual review and blood test, together with general lifestyle advice. | Behavioral: Wait-list control (usual care)<br>* Participants in the control group will be invited to have an annual review and blood test at baseline, 4 and 12 months and received general lifestyle advices from a registered nurse at a community clinic.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent weight change | % weight change from baseline | % weight change at 4 and 12 months from baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Changes of insulin sensitivity at 12-months from baseline | 
| Fasting insulin | Fasting insulin in mU/L | Changes of fasting insulin to 12-months from baseline | 
| Fasting blood glucose (FG) | Fasting blood glucose in mmol/L > 8 hours of fasting | Changes of FG at 12-months from baseline | 
| Haemoglobin A1C (HbA1C) | HbA1c in % | Changes of HbA1c at 4 and 12-months from baseline | 
| Systolic and diastolic blood pressure (SBP, DBP) | in mmHg measured by automatic BP monitor | 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 | Changesof blood lipid at 12-months from baseline | 
| 2hr post OGTT glucose (2hr PP) | Blood glucose in mmol/L 2 hours after OGTT | Changes of 2hr PP at 12-months from baseline | 
| Physical activity as assessed by IPAQ | 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: 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 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. Low-active/inactive group Individuals who do not meet criteria for high- and moderate-active | Change in levels of physical activity from baseline to 4 and 12-months | 
| Dietary intake as assessed by 24-hour recall | 24-hour food recall | Changes in dietary intake from baseline to 4 and 12-months | 
| Health-related quality of life (HRQOL) as assessed by SF12 | 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. | Changes in HRQOL from baseline to 4 and 12-months | 
| Central obesity | Waist circumference in cm | Changes of waist circumference at 12-months from baseline | 
| Percentage body fat as assessed by BIA | Bioelectrical impedance analysis measuring body fat in % | Changes of body fat at 12-months from baseline | 
| Smartphone apps user engagement | 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. | At 12-months follow-up | 
| User feedback as assessed by an online exit questionnaire | An online exit questionnaire will be administered to participants in the intervention group at 12 months. | At 12-months follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes prevention, Pre-diabetes, Weight loss, Cardio-metabolic risk, Obesity, Lifestyle intervention, Smartphone-based