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

October 16, 2021 updated by: Dr. Mandy M. Ho, The University of Hong Kong

Effects of a Community-based Weight Loss Programme Targetting 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. 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 .

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • The University of Hong Kong

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Community-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.
Behavioral: group-based lifestyle intervention
Involve education about pre-diabetes self-management, weight loss, behavioural modification skills, nutrition and physical activity.
Other Names:
  • individual dietitian consultation
  • Telephone support
  • community-based intervention
OTHER: 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.
Behavioral: Minimal intervention (SMS intervention)
Text message related to general information about T2DM, pre-diabetes, and lifestyle modification.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Hong Kong

Investigators

  • Principal Investigator: Dr Mandy Ho, The University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 10, 2018

Primary Completion (ANTICIPATED)

May 31, 2022

Study Completion (ANTICIPATED)

May 31, 2024

Study Registration Dates

First Submitted

July 13, 2018

First Submitted That Met QC Criteria

July 24, 2018

First Posted (ACTUAL)

August 1, 2018

Study Record Updates

Last Update Posted (ACTUAL)

October 25, 2021

Last Update Submitted That Met QC Criteria

October 16, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HCPS01170498

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is no plan to make individual participant data available to other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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