Behavioural Economics-based Incentives in Adults With Type 2 Diabetes Pilot Study

NCT04443842 | Completed

• 1 other identifier: BET2-v2-202005
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

A feasibility pilot study of a randomised control trial of adults newly diagnosed with type 2 diabetes to compare the effectiveness of financial and social incentives on healthy lifestyle behaviour.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Glycemic control

  Change in HbA1c levels

  Baseline, 6 and 9 months

Secondary Outcomes (4)

• Change in physical activity (step count)

  Baseline, 6 and 9 months

• Change in body weight

  Baseline, 6 and 9 months

• Changes in lipid profile

  Baseline, 6 and 9 months

• Change in physical activity level

  Baseline, 6 and 9 months

Other Outcomes (1)

• Change in health service utilisation

  Baseline, 6 and 9 months

Study Arms (2)

Intervention

EXPERIMENTAL

Participants will receive the usual standard care (same as control group), loss-framed financial incentive, 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.

Interventions

Financial and social incentives BEHAVIORAL

Participants will be credited with HK$1000 in their virtual accounts at the beginning of the trial. After baseline step counts are gathered in the second week, participants will lose HK$40 for each subsequent week that they do not meet their personal weekly step target. The social incentives are peer comparison and social support. Participants receive feedback of their physical activity performance by assessing whether they met or exceeded their step count target, followed by positive messages for encouragement. Nominated supporters will be informed of participants' performance for social support.

Intervention

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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
• Newly diagnosed with type 2 diabetes within a year according to World Health Organization guidelines: HbA1c ≥ 48 mmol/mol (≥ 6.5%); fasting plasma glucose ≥ 7.0 mmol/l (≥ 126 mg/dl); oral glucose tolerance test (OGTT) ≥ 11.1 mmol/l (200 mg/dl) with symptoms, or on two separate occasions if asymptomatic
• HbA1c ≤ 7.5%
• Not taking any medication for glycaemic control
• Willing to take blood tests
• Access to a smart phone to track physical activity
• Physically mobile for duration of the trial

You may not qualify if:

• Already participating in another intervention study
• Any health condition prohibiting them from completing the 9-month trial, such as history of eating disorder, cancer, serious illness, breastfeeding
• Medical conditions that can affect HbA1c measurements including anaemia, haemoglobinopathies, haemodialysis, iron/B12 deficiency or supplements, chronic liver diseases, splenectomy, rheumatoid arthritis, use of anti-retroviral drugs, ribavirin, or aspirin
• Intend to receive medication for glycaemic control in the next 6 months
• Intend to seek private medical treatment for diabetes in the next 6 months

Sponsors & Collaborators

• The University of Hong Kong: lead
• University Grants Committee, Hong Kong: collaborator

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 Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine 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: June 17, 2020
• First Posted: June 23, 2020
• Study Start: November 1, 2020
• Primary Completion: September 6, 2021
• Study Completion: December 7, 2021
• Last Updated: May 18, 2022

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

HK (1)