Pre-diabetes
Conditions
Keywords
Diabetes prevention, Pre-diabetes, Weight loss, Cardio-metabolic risk, Obesity, Lifestyle intervention, Smartphone-based
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.
Interventions
BEHAVIORALDigital diabetes prevention app intervention
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.
BEHAVIORALDigital weight loss tracking app intervention
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.
BEHAVIORALWait-list control (usual care)
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.
Sponsors
The University of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
All outcome assessors will be blinded to group allocation
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
40 Years to 60 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent weight change | % weight change at 4 and 12 months from baseline | % weight change from baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Fasting blood glucose (FG) | Changes of FG at 12-months from baseline | Fasting blood glucose in mmol/L \> 8 hours of fasting |
| 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 |
| 2hr post OGTT glucose (2hr PP) | Changes of 2hr PP at 12-months from baseline | Blood glucose in mmol/L 2 hours after OGTT |
| Dietary intake as assessed by 24-hour recall | Changes in dietary intake from baseline to 4 and 12-months | 24-hour food recall |
| 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. |
| Central obesity | Changes of waist circumference at 12-months from baseline | Waist circumference in cm |
| Percentage body fat as assessed by BIA | Changes of body fat at 12-months from baseline | Bioelectrical impedance analysis measuring body fat in % |
| 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. |
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Diabetes incidence | At 12-months follow-up | 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 |
Countries
Hong Kong
Contacts
Primary ContactDr Mandy Ho
Outcome results
None listed