search
Back to results

Diabetes Risk Communication Tool Evaluation

Primary Purpose

Type 2 Diabetes

Status
Completed
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
T2D Risk Communication Tool: Relative Risk
T2D Risk Communication Tool: Metabolic Age
T2D Risk Communication Tool: Traffic Light
Sponsored by
National University of Singapore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Type 2 Diabetes

Eligibility Criteria

30 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • National University of Singapore

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Usual Care

Relative Risk

Metabolic Age

Arm Description

Outcomes

Primary Outcome Measures

Differences in reaction to risk communication between arms
Participants' emotional responses to their risk results are assessed using 6 items like "I found the results worrying" and "I am reassured by these results". 3 additional items are used to assess their reaction to the process and confidence towards the tool by asking about their understanding of the results and if they will encourage others to use the tool. Participants will answer these on a 5-point scale, ranging from 'strongly disagree' to 'strongly agree.' Participants' cognitive reactions to their risk results are assessed using 3 items to evaluate their risk perception in five years, ten years, and in relation to others. Participants will answer these on a 5-point scale, ranging from 'very unlikely' to 'very likely.'
Differences in behaviour intention between arms
Assessed using 10 items to understand the intention to improve their health-promoting behaviours after they have gone through one of the risk assessment tools. Items ask questions like "After seeing my results, I intend to have fewer sugary drinks (soda, fruit juice, bubble tea) in a week" and "After seeing my results, I intend to do more moderate to vigorous exercise (ie brisk walking, jogging, weight lifting, etc) in a week" Responses are evaluated on a 5-point scale, from "Extremely Unlikely to Extremely Likely".

Secondary Outcome Measures

Empirical evidence of using PMT constructs in developing interventions
We measure the different PMT constructs (perceived severity, perceived vulnerability, response efficacy, self-efficacy, and response costs). This will allow us to observe how the different tools differ and if these constructs are associated with the primary outcome measures. Responses are evaluated on a 7-point scale, ranging from 'definitely disagree' to 'definitely agree.'

Full Information

First Posted
June 10, 2022
Last Updated
September 19, 2023
Sponsor
National University of Singapore
Collaborators
National Medical Research Council (NMRC), Singapore
search

1. Study Identification

Unique Protocol Identification Number
NCT05427890
Brief Title
Diabetes Risk Communication Tool Evaluation
Official Title
Evaluation of Diabetes Risk Communication Tool to Promote Behaviour Change for Prevention of Type 2 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
June 20, 2022 (Actual)
Primary Completion Date
August 7, 2023 (Actual)
Study Completion Date
August 7, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National University of Singapore
Collaborators
National Medical Research Council (NMRC), Singapore

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
460 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual Care
Arm Type
Active Comparator
Arm Title
Relative Risk
Arm Type
Experimental
Arm Title
Metabolic Age
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
T2D Risk Communication Tool: Relative Risk
Intervention Description
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
Intervention Name(s)
T2D Risk Communication Tool: Metabolic Age
Intervention Description
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
Intervention Name(s)
T2D Risk Communication Tool: Traffic Light
Intervention Description
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.
Primary Outcome Measure Information:
Title
Differences in reaction to risk communication between arms
Description
Participants' emotional responses to their risk results are assessed using 6 items like "I found the results worrying" and "I am reassured by these results". 3 additional items are used to assess their reaction to the process and confidence towards the tool by asking about their understanding of the results and if they will encourage others to use the tool. Participants will answer these on a 5-point scale, ranging from 'strongly disagree' to 'strongly agree.' Participants' cognitive reactions to their risk results are assessed using 3 items to evaluate their risk perception in five years, ten years, and in relation to others. Participants will answer these on a 5-point scale, ranging from 'very unlikely' to 'very likely.'
Time Frame
1 day
Title
Differences in behaviour intention between arms
Description
Assessed using 10 items to understand the intention to improve their health-promoting behaviours after they have gone through one of the risk assessment tools. Items ask questions like "After seeing my results, I intend to have fewer sugary drinks (soda, fruit juice, bubble tea) in a week" and "After seeing my results, I intend to do more moderate to vigorous exercise (ie brisk walking, jogging, weight lifting, etc) in a week" Responses are evaluated on a 5-point scale, from "Extremely Unlikely to Extremely Likely".
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Empirical evidence of using PMT constructs in developing interventions
Description
We measure the different PMT constructs (perceived severity, perceived vulnerability, response efficacy, self-efficacy, and response costs). This will allow us to observe how the different tools differ and if these constructs are associated with the primary outcome measures. Responses are evaluated on a 7-point scale, ranging from 'definitely disagree' to 'definitely agree.'
Time Frame
1 day
Other Pre-specified Outcome Measures:
Title
Objective Risk Score
Description
We collect the health screening data the participants are using to engage with the risk assessment tools to compute their objective risk scores. This will allow us to observe any associations between the different risk groups (ie low, moderate, or high) and the primary and secondary outcome measures. Data used in the risk model to calculate the objective risk score: age, sex, height, weight, systolic and diastolic blood pressure, use of blood pressure medication, triglycerides, HbA1C, parental history of T2D, and average exercise minutes per week.
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Huso Yi, PhD
Organizational Affiliation
National University of Singapore
Official's Role
Principal Investigator
Facility Information:
Facility Name
National University of Singapore
City
Singapore
Country
Singapore

12. IPD Sharing Statement

Learn more about this trial

Diabetes Risk Communication Tool Evaluation

We'll reach out to this number within 24 hrs