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

Not Applicable

• Conditions: Pre-diabetes
• Interventions: Behavioral: group-based lifestyle intervention; Behavioral: Minimal intervention (SMS intervention)

• Registration Number: NCT03609697
• Lead Sponsor: The University of Hong Kong

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-07-13
• Study First Submitted QC: 2018-07-24
• Study First Posted: 2018-08-01
• Study Start: 2018-08-10
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-16
• Last Update Posted: 2021-10-25
• Primary Completion: 2022-05-31
• Study Completion: 2024-05-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 180

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.

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Community-based lifestyle intervention	group-based lifestyle intervention	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.
Minimal intervention (SMS intervention)	Minimal intervention (SMS intervention)	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.

Primary Outcome Measures

Name	Time	Method
Percent weight change	% weight change from baseline at 6-month and 12-months	% weight change from baseline

Secondary Outcome Measures

Name	Time	Method
Systolic and diastolic blood pressure (SBP, DBP)	Changes from baseline SBP and DBP at 6-month and 12-months	measured by automatic BP monitor
Haemoglobin A1C (HbA1C)	Changes from baseline HbA1Cat 6-month and 12-months	HbA1C
Diabetes status	6-month and 12-months follow-up	Oral glucose tolerance test
Carotid artery intima-media thickness (cIMT)	Change in cIMT from baseline to 6-month and 12-months	High-resolution B-mode ultrasonography
Fasting insulin	Changes from baseline fasting insulin at 6-month and 12-months	Fasting insulin
Dietary intake	Changes in dietary intake from baseline to 6-month and 12-months	24 hour recalls
Health-related quality of life (HRQOL)	Changes in HRQOL from baseline to 6-month 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.
Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)	Changes from baseline insulin sensitivity at 6-month and 12-months	Estimated from fasting insulin and fasting glucose, \[fasting insulin (uU/mL)\*fasting glucose(mmol/L)\]/22.5
Fasting blood glucose (FG)	Changes from baseline FG at 6-month and 12-months	Fasting blood glucose
Blood lipid profile	Changes from baseline blood lipid to 6-month and 12-months	fasting blood for total cholesterol, HDL, LDL and triglycerides
Physical activity	Change in levels of physical activity from baseline to 6-month 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

Trial Locations

Locations (1)

The University of Hong Kong; 🇭🇰 Hong Kong, Hong Kong