Clinical trial NCT03609697: A Community-based Weight Loss Programme for Chinese Overweight 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pre-diabetes
Keywords: Diabetes prevention
Pre-diabetes
Weight loss
Cardio-metabolic risks
Obesity
Lifestyle intervention
Community-based
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2018-08-01
Enrollment: 180
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

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.

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)

Primary outcomes:
measure: Percent weight change
timeFrame: % weight change from baseline at 6-month and 12-months
Secondary outcomes:
measure: Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
timeFrame: Changes from baseline insulin sensitivity at 6-month and 12-months
measure: Fasting insulin
timeFrame: Changes from baseline fasting insulin at 6-month and 12-months
measure: Fasting blood glucose (FG)
timeFrame: Changes from baseline FG at 6-month and 12-months
measure: Haemoglobin A1C (HbA1C)
timeFrame: Changes from baseline HbA1Cat 6-month and 12-months
measure: Systolic and diastolic blood pressure (SBP, DBP)
timeFrame: Changes from baseline SBP and DBP at 6-month and 12-months
measure: Blood lipid profile
timeFrame: Changes from baseline blood lipid to 6-month and 12-months
measure: Diabetes status
timeFrame: 6-month and 12-months follow-up
measure: Physical activity
timeFrame: Change in levels of physical activity from baseline to 6-month and 12-months
measure: Dietary intake
timeFrame: Changes in dietary intake from baseline to 6-month and 12-months
measure: Health-related quality of life (HRQOL)
timeFrame: Changes in HRQOL from baseline to 6-month and 12-months
measure: Carotid artery intima-media thickness (cIMT)
timeFrame: Change in cIMT from baseline to 6-month and 12-months
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The University of Hong Kong
Study officials:
affiliation: The University of Hong Kong
name: Dr Mandy Ho
role: PRINCIPAL_INVESTIGATOR
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