Diabetes Risk Communication Tool Evaluation

NCT ID: NCT05427890

Last Updated: 2023-09-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 460 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-20
• Study Completion Date: 2023-08-07

Brief Summary

Prevention for Type 2 Diabetes (T2D)has been vast but with limited success. While Singaporeans have high knowledge about T2D, its symptoms, and risk factors, healthy practices are still sub-optimal. Upon a qualitative investigation, it was found that there is little to no urgency to engage in T2D preventative behaviour due to to the low perceived threat, and high costs from required lifestyle changes relative to the benefits. Hence, this project targets to communicate the risk of diabetes in a more salient and effective way to improve the intention of preventative behaviour by targeting the constructs of Protection Motivation Theory (PMT) and increasing the threat and coping appraisals. The current available diabetes risk assessment tool's result page provides a binary output: "Higher vs Lower" Risk of being pre-diabetic. This aligns with the usual care practiced in clinics currently; patients are told if they are pre-diabetic or not. It does not provide any personalized or relevant tips on how to reduce risk. Hence, there was a demonstrated need to develop risk assessment tools that increase threat appraisal and communicate T2D risk in a more salient way to motivate the intention of behaviour change. The investigators developed two tools: Relative Risk, and Metabolic Age. The Relative Risk prototype demonstrates the user's relative risk on a scale of 1 to 10, in comparison to someone of the same age and sex. The number 1-10 represents their position in the percentile distribution of their risk scores. The Metabolic Age is identified by matching the risk score's percentile position to percentile of the incidence of T2D. The median age of the people in that percentile is reflected as the metabolic age. The primary objectives of this study is to evaluate which of these risk presentations (Usual care, relative risk, or metabolic age) evoke (i) effective cognitive and emotional responses to risk results and (2) motivation for the intention of behaviour change. The secondary objective is to provide empirical evidence for using PMT constructs in intervention development. The hypothesis is that those who are exposed to the Metabolic Age risk assessment and communication tool will have the most effective cognitive and emotional response, and the highest intention of engaging in behaviour change, followed by those exposed to relative risk, and then standard of care.

Conditions

Type 2 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Usual Care

Group Type: ACTIVE_COMPARATOR

T2D Risk Communication Tool: Traffic Light

Intervention Type: BEHAVIORAL

Risk of T2D is presented as either High (Red) or Low (Green). Generic tips on how to reduce risk of diabetes are included. This imitates the tool that is currently available for residents of Singapore to use to assess their risk of T2D.

Relative Risk

Group Type: EXPERIMENTAL

T2D Risk Communication Tool: Relative Risk

Intervention Type: BEHAVIORAL

Risk of T2D is presented in comparison to the rest of the Singapore population in a scale 1-10. Suggestions on different lifestyle changes and its potential to reduce the individual's relative risk is presented for user to observe impact of preventative behaviours.

Metabolic Age

Group Type: EXPERIMENTAL

T2D Risk Communication Tool: Metabolic Age

Intervention Type: BEHAVIORAL

Risk of T2D is presented as an age, compared to their chronological age as a proxy for their current health status. Suggestions on different lifestyle changes and its potential to reduce the individual's metabolic age is presented for user to observe impact of preventative behaviours.

Interventions

T2D Risk Communication Tool: Relative Risk

Risk of T2D is presented in comparison to the rest of the Singapore population in a scale 1-10. Suggestions on different lifestyle changes and its potential to reduce the individual's relative risk is presented for user to observe impact of preventative behaviours.

Intervention Type: BEHAVIORAL

T2D Risk Communication Tool: Metabolic Age

Risk of T2D is presented as an age, compared to their chronological age as a proxy for their current health status. Suggestions on different lifestyle changes and its potential to reduce the individual's metabolic age is presented for user to observe impact of preventative behaviours.

Intervention Type: BEHAVIORAL

T2D Risk Communication Tool: Traffic Light

Risk of T2D is presented as either High (Red) or Low (Green). Generic tips on how to reduce risk of diabetes are included. This imitates the tool that is currently available for residents of Singapore to use to assess their risk of T2D.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Aged 30-60 years;
• Singapore citizen, or permanent resident
• Able to read and understand English,
• Have had a health screening with blood pressure, triglycerides, and HbA1C done within the last 3 months
• At least one risk factor for Type 2 Diabetes (BMI ≥ 23 kg/m2, blood pressure ≥130/85 mmHg or receiving therapy for hypertension, triglycerides ≥1.7mmol/L or HbA1c ≥5.7%)

Exclusion Criteria

• Diagnosis of any event of cardiovascular disease, kidney issues, or type 2 diabetes

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Medical Research Council (NMRC), Singapore

OTHER_GOV

Sponsor Role: collaborator

National University of Singapore

OTHER

Sponsor Role: lead

Responsible Party

Huso Yi

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Huso Yi, PhD

Role: PRINCIPAL_INVESTIGATOR

National University of Singapore

Locations

National University of Singapore

Singapore, , Singapore

Countries

Singapore

Other Identifiers

NUS-IRB-2021-633

Identifier Type: OTHER

Identifier Source: secondary_id

OF-LCG-RiskComm

Identifier Type: -

Identifier Source: org_study_id