- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05427890
Diabetes Risk Communication Tool Evaluation
Evaluation of Diabetes Risk Communication Tool to Promote Behaviour Change for Prevention of Type 2 Diabetes
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Huso Yi, PhD
- Phone Number: 6516 4988
- Email: husoyi@nus.edu.sg
Study Locations
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-
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Singapore, Singapore
- National University of Singapore
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Active Comparator: Usual Care
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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.
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Experimental: Relative Risk
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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.
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Experimental: Metabolic Age
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Differences in behaviour intention between arms
Time Frame: 1 day
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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".
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1 day
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Differences in reaction to risk communication between arms
Time Frame: 1 day
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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.' |
1 day
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Empirical evidence of using PMT constructs in developing interventions
Time Frame: 1 day
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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.'
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1 day
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Objective Risk Score
Time Frame: 1 day
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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.
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1 day
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Huso Yi, PhD, National University of Singapore
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- OF-LCG-RiskComm
- NUS-IRB-2021-633 (Other Identifier: National University, Singapore)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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