Type 2 DiabetesNCT05427890
Diabetes Risk Communication Tool Evaluation
A study testing T2D Risk Communication Tool: Relative Risk, T2D Risk Communication Tool: Metabolic Age and T2D Risk Communication Tool: Traffic Light in people with Type 2 Diabetes, run by National University of Singapore at 1 site in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- T2D Risk Communication Tool: Relative Risk, T2D Risk Communication Tool: Metabolic Age and T2D Risk Communication Tool: Traffic Light
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 460 participants
- Where
- 1 siteSingapore
- Study dates
- 20 Jun 2022to 7 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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%)
Who cannot join
- Diagnosis of any event of cardiovascular disease, kidney issues, or type 2 diabetes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Diabetes Risk Communication Tool to Promote Behaviour Change for Prevention of Type 2 Diabetes
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
- Being tested
- T2D Risk Communication Tool: Relative Risk, T2D Risk Communication Tool: Metabolic Age, T2D Risk Communication Tool: Traffic Light
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
T2D Risk Communication Tool: Relative RiskBehavioural
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.
T2D Risk Communication Tool: Metabolic AgeBehavioural
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.
T2D Risk Communication Tool: Traffic LightBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | Active comparator | Not described Receives: Behavioral: T2D Risk Communication Tool: Traffic Light |
| Relative Risk | Experimental | Not described Receives: Behavioral: T2D Risk Communication Tool: Relative Risk |
| Metabolic Age | Experimental | Not described Receives: Behavioral: T2D Risk Communication Tool: Metabolic Age |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.'
Measured: 1 day
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".
Measured: 1 day
Secondary outcomes (1)
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.'
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2022
- Study start20 Jun 2022
- Primary completion7 Aug 2023
- Study completion7 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 460 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University of Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- National Medical Research Council (NMRC), Singapore
- Responsible party
- Principal investigator, Huso Yi, National University of Singapore
- Investigators
- Huso Yi, PhD, Principal investigator, National University of Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05427890
- Sponsor's protocol ID
- OF-LCG-RiskComm
- Other IDs
- NUS-IRB-2021-633
- Status last verified
- Sep 2023
- First submitted
- 10 Jun 2022
- Last updated
- 21 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Diabetes Risk Communication Tool to Promote Behaviour Change for Prevention of Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT05427890
- Acronym / sponsor ID
- OF-LCG-RiskComm
- Conditions
- Type 2 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 460 participants (actual)
- Lead sponsor
- National University of SingaporeUniversity, hospital or other
- Collaborators
- National Medical Research Council (NMRC), Singapore
- Study start
- 20 Jun 2022 (actual)
- Primary completion
- 7 Aug 2023 (actual)
- Study completion
- 7 Aug 2023 (actual)
- First posted
- 22 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Usual Care | Active comparator | Behavioral: T2D Risk Communication Tool: Traffic Light |
| Relative Risk | Experimental | Behavioral: T2D Risk Communication Tool: Relative Risk |
| Metabolic Age | Experimental | Behavioral: T2D Risk Communication Tool: Metabolic Age |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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%)
Key exclusion criteria (1 listed)
- Diagnosis of any event of cardiovascular disease, kidney issues, or type 2 diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| T2D Risk Communication Tool: Relative RiskRisk 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. | Behavioural | Relative Risk |
| T2D Risk Communication Tool: Metabolic AgeRisk 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. | Behavioural | Metabolic Age |
| T2D Risk Communication Tool: Traffic LightRisk 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. | Behavioural | Usual Care |
Primary outcome
Differences in reaction to risk communication between arms
Time frame: 1 day
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
Time frame: 1 day
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".
1 secondary outcome
Empirical evidence of using PMT constructs in developing interventions
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Huso Yi, PhD principal investigator
National University of Singapore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing T2D Risk Communication Tool: Relative Risk, T2D Risk Communication Tool: Metabolic Age and T2D Risk Communication Tool: Traffic Light in people with Type 2 Diabetes, run by National University of Singapore at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences in reaction to risk communication between arms (time frame: 1 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2023.