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

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

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

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.

Diabetes prevention, Pre-diabetes, Weight loss, Cardio-metabolic risk, Obesity, Lifestyle intervention, Smartphone-based

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.

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

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

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

Web-based diabetes prevention curriculum, Goal setting and self-monitoring, Virtual social support group

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.

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.

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.

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

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

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.

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.

An online exit questionnaire will be administered to participants in the intervention group at 12 months.

Oral glucose tolerance test (OGTT) in mmol/L measured 2 hours after 75g oral glucose intake post overnight fast. Diabetes is defined as FG≥7.0mmol/L or 2hr post OGTT ≥ 11.1mmol/L

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)

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