A Community-based Weight Loss Programme for Chinese Overweight Adults With Pre-diabetes

Study Overview
=================
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. Pre-diabetes is a prevalent and potentially reversible condition, 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 a community setting to reduce diabetes risks in Hong Kong Chinese people with pre-diabetes .

Detailed Description
-----------------
Type 2 diabetes (T2DM) is a major non-communicable disease and one of the world's fastest growing health problem. It is associated with significant morbidity, including increased risk of heart disease and stroke, hypertension, retinopathy and blindness, renal failure and leg amputation, which place an enormous burden on individuals, society and the healthcare system. The T2DM trend in Hong Kong mirrors the global trend. It is a major cause of mortality and morbidity with approximately 700,000 people diagnosed with diabetes, representing 10% of Hong Kong's total population. T2DM is a non-reversible, yet a preventable condition. The onset of T2DM is gradual, with most individuals progressing through a state of 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. International clinical trials demonstrated that lifestyle interventions targeting at least 5% weight loss in individuals with pre-diabetes can be cost-effective in preventing T2DM. Lifestyle intervention (which includes diet, physical activity and behavioural modification components) and self-management of pre-diabetes has been listed as an effective means of decreasing the incidence of T2DM in the international guidelines on management of pre-diabetes. The aim of this study is to translate preventive research into effective community-based intervention by setting up a culturally appropriate lifestyle intervention programme for the prevention of T2DM in Hong Kong Chinese adults with pre-diabetes.

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

Conditions
-----------------
Pre-diabetes

Intervention / Treatment
-----------------
* Behavioral: group-based lifestyle intervention
* Behavioral: Minimal intervention (SMS intervention)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: aged 30 to 65 years 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% have a mobile phone 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 (e.g. Metformin) or long-term use of medications known to influence glucose metabolism (e.g. corticosteroids)

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: It is a 12-month 2-arm randomised controlled trial, RCT (the lifestyle intervention group and the SMS intervention group) with a 3 year follow up. The programme will proceed in two phases: the intensive intervention phase (0-6 months) and the maintenance phase (7-12 months). During the intensive intervention phase, participants in the lifestyle intervention group will attend 7 group-based interventions plus two sessions of individual face-to-face dietician consultation. During the maintenance phase, participants will receive monthly phone call from the research team. The SMS intervention group will receive regular SMS during both the intensive intervention and the maintenance phases.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Community-based lifestyle intervention<br>Participants will attend 7 community-based group intervention sessions plus 2 individual face-to-face dietician consultation sessions during the first 6 months, followed by a 6-month maintenance phase which they will receive monthly phone support from the research team. | Behavioral: group-based lifestyle intervention<br>* Involve education about pre-diabetes self-management, weight loss, behavioural modification skills, nutrition and physical activity.<br>* Other names: community-based intervention;|
| Other: Minimal intervention (SMS intervention)<br>Participants will receive one SMS per month during the first 6 months, followed by a 6-month maintenance phase which participants will receive one SMS every 2 months. | Behavioral: Minimal intervention (SMS intervention)<br>* Text message related to general information about T2DM, pre-diabetes, and lifestyle modification.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent weight change | % weight change from baseline | % weight change from baseline at 6-month and 12-months | 

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 from baseline insulin sensitivity at 6-month and 12-months | 
| Fasting insulin | Fasting insulin | Changes from baseline fasting insulin at 6-month and 12-months | 
| Fasting blood glucose (FG) | Fasting blood glucose | Changes from baseline FG at 6-month and 12-months | 
| Haemoglobin A1C (HbA1C) | HbA1C | Changes from baseline HbA1Cat 6-month and 12-months | 
| Systolic and diastolic blood pressure (SBP, DBP) | measured by automatic BP monitor | Changes from baseline SBP and DBP at 6-month and 12-months | 
| Blood lipid profile | fasting blood for total cholesterol, HDL, LDL and triglycerides | Changes from baseline blood lipid to 6-month and 12-months | 
| Diabetes status | Oral glucose tolerance test | 6-month and 12-months follow-up | 
| Physical activity | 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 6-month and 12-months | 
| Dietary intake | 24 hour recalls | Changes in dietary intake from baseline to 6-month and 12-months | 
| Health-related quality of life (HRQOL) | 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 6-month and 12-months | 
| Carotid artery intima-media thickness (cIMT) | High-resolution B-mode ultrasonography | Change in cIMT from baseline to 6-month and 12-months | 

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