A Smartphone-based Intervention for Diabetes Prevention in Overweight Chinese Adults With Pre-diabetes

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

Effects of a Smartphone-based Weight Loss Programme Targeting 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, 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

282

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 Contact

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Recruiting
        • The University of Hong Kong
        • Contact:
        • Principal Investigator:
          • Mandy Ho, PhD
        • Sub-Investigator:
          • Pui Hing Chau, PhD
        • Sub-Investigator:
          • Esther Yee Tak Yu
        • Sub-Investigator:
          • Ming Fai Siu, PhD
        • Sub-Investigator:
          • Michael Tin Cheung Ying, PhD

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

36 years to 56 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

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 Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Digital diabetes prevention app intervention
Participants will receive web-based diabetes prevention curriculum, virtual social group support and digital tracking via the smartphone app.
Behavioral: Digital 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.

Other Names:
  • Web-based diabetes prevention curriculum
  • Goal setting and self-monitoring
  • Virtual social support group
Active Comparator: Digital weight loss tracking app intervention
Participants will receive the same intervention as the digital diabetes prevention curriculum app group except the web-based diabetes prevention curriculum.
Behavioral: Digital 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.

Other Names:
  • Goal setting and self-monitoring
  • Virtual social support group
Other: Wait-list control (usual care)
Participants will receive usual care in the form of an annual review and blood test, together with general lifestyle advice.
Behavioral: Wait-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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent weight change
Time Frame: % weight change at 4 and 12 months from baseline
% weight change from baseline
% weight change at 4 and 12 months from baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
Time Frame: 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
Changes of insulin sensitivity at 12-months from baseline
Fasting insulin
Time Frame: Changes of fasting insulin to 12-months from baseline
Fasting insulin in mU/L
Changes of fasting insulin to 12-months from baseline
Fasting blood glucose (FG)
Time Frame: Changes of FG at 12-months from baseline
Fasting blood glucose in mmol/L > 8 hours of fasting
Changes of FG at 12-months from baseline
Haemoglobin A1C (HbA1C)
Time Frame: Changes of HbA1c at 4 and 12-months from baseline
HbA1c in %
Changes of HbA1c at 4 and 12-months from baseline
Systolic and diastolic blood pressure (SBP, DBP)
Time Frame: Changes of SBP and DBP to 4 and 12-months from baseline
in mmHg measured by automatic BP monitor
Changes of SBP and DBP to 4 and 12-months from baseline
Blood lipid profile
Time Frame: Changesof blood lipid at 12-months from baseline
fasting blood for total cholesterol, HDL, LDL and triglycerides, all in mmol/L
Changesof blood lipid at 12-months from baseline
2hr post OGTT glucose (2hr PP)
Time Frame: Changes of 2hr PP at 12-months from baseline
Blood glucose in mmol/L 2 hours after OGTT
Changes of 2hr PP at 12-months from baseline
Physical activity as assessed by IPAQ
Time Frame: 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
Change in levels of physical activity from baseline to 4 and 12-months
Dietary intake as assessed by 24-hour recall
Time Frame: Changes in dietary intake from baseline to 4 and 12-months
24-hour food recall
Changes in dietary intake from baseline to 4 and 12-months
Health-related quality of life (HRQOL) as assessed by SF12
Time Frame: 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.
Changes in HRQOL from baseline to 4 and 12-months
Central obesity
Time Frame: Changes of waist circumference at 12-months from baseline
Waist circumference in cm
Changes of waist circumference at 12-months from baseline
Percentage body fat as assessed by BIA
Time Frame: Changes of body fat at 12-months from baseline
Bioelectrical impedance analysis measuring body fat in %
Changes of body fat at 12-months from baseline
Smartphone apps user engagement
Time Frame: 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.
At 12-months follow-up
User feedback as assessed by an online exit questionnaire
Time Frame: At 12-months follow-up
An online exit questionnaire will be administered to participants in the intervention group at 12 months.
At 12-months follow-up

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diabetes incidence
Time Frame: 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
At 12-months follow-up

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, 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)

June 1, 2021

Primary Completion (Anticipated)

May 31, 2024

Study Completion (Anticipated)

May 31, 2024

Study Registration Dates

First Submitted

May 1, 2021

First Submitted That Met QC Criteria

May 1, 2021

First Posted (Actual)

May 6, 2021

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

  • HMRF03180248

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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