NCT04917926

Brief Summary

A randomised control trial of adults with newly diagnosed type 2 diabetes to assess the effectiveness of behavioural economics-based incentives on healthy lifestyle behaviour, using a pragmatic trial approach.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
122

participants targeted

Target at P50-P75 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Jun 2021

Typical duration for not_applicable diabetes-mellitus-type-2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 28, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 8, 2021

Completed
13 days until next milestone

Study Start

First participant enrolled

June 21, 2021

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

May 9, 2024

Status Verified

October 1, 2022

Enrollment Period

2.5 years

First QC Date

April 28, 2021

Last Update Submit

May 8, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Glycaemic control

    The change in HbA1c levels

    Baseline, 6-months, and 9-months

Secondary Outcomes (8)

  • Diabetes control

    Baseline, 6-months, and 9-months

  • Body weight control

    Baseline, 6-months, and 9-months

  • Changes in lipid profile

    Baseline, 6-months, and 9-months

  • Change in blood pressure

    Baseline, 6-months, and 9-months

  • Glycaemic control

    6-months and 9-months

  • +3 more secondary outcomes

Other Outcomes (1)

  • Frequency of health service utilisation

    Baseline, 6-months, and 9-months

Study Arms (3)

Financial and social intervention

EXPERIMENTAL

Participants will receive the usual standard care (same as control group), loss-framed financial incentives, social incentives and weekly feedback on performance for 6 months.

Behavioral: Financial and social incentives

Control

NO INTERVENTION

Participants will receive standard care including patient screening and education on diet, physical activity, and smoking conducted by a multi-disciplinary team. Participants in the control group will neither be told their baseline step count nor receive any feedback messages.

Financial intervention

EXPERIMENTAL

Participants will receive the usual standard care (same as control group), loss-framed financial incentives, and weekly feedback on performance for 6 months.

Behavioral: Financial incentives

Interventions

Participants will be credited with HK$1,000 in their virtual accounts at the beginning of the trial. After baseline step counts are gathered in the second week, they will lose HK$40 for each subsequent week that they do not meet their personal weekly step target. Regarding social incentives, participants will be placed in teams of six, receiving feedback of their physical activity performance, rankings within their groups, and positive messages for encouragement. Nominated supporters will be informed of participants' performance for social support.

Financial and social intervention

Participants will be credited with HK$1,000 in their virtual accounts at the beginning of the trial. After baseline step counts are gathered in the second week, they will lose HK$40 for each subsequent week that they do not meet their personal weekly step target.

Financial intervention

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Chinese adults aged 30-70 years
  • Capable of providing informed consent
  • Resident in Hong Kong
  • Able to communicate in English or Chinese
  • Diagnosed with type 2 diabetes within past year
  • % ≤ HbA1c ≤ 9.0%
  • Willing to take blood tests
  • Access to a phone to track physical activity and receive text messages
  • Physically mobile for duration of the trial

You may not qualify if:

  • Planned surgery in the next 6 months
  • Biological impairment or health condition affecting the ability to walk, such as blindness, physical immobility, and paralysis
  • Pregnant or breastfeeding
  • On insulin for diabetes control

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Public Health, Li Ka Shing Faculty of Medicine, The University of Hong Kong

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Jianchao Quan, MPH, BM BCh

    School of Public Health, The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 28, 2021

First Posted

June 8, 2021

Study Start

June 21, 2021

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

May 9, 2024

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will share

Information will be shared in accordance with the University of Hong Kong Data Management Plan (DMP)

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Data will become available for at least 5 years after the release of publication of this study.
Access Criteria
Only data without personal information will be shared. The data will be shared for academic use only.
More information

Locations