跳至主要内容
临床试验/NCT05427890
NCT05427890已完成不适用

Evaluation of Diabetes Risk Communication Tool to Promote Behaviour Change for Prevention of Type 2 Diabetes

National University of Singapore1 个研究点 分布在 1 个国家目标入组 460 人开始时间: 2022年6月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
460
试验地点
1
主要终点
Differences in reaction to risk communication between arms

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

入排标准

年龄范围
30 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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%)

排除标准

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

结局指标

主要结局

Differences in reaction to risk communication between arms

时间窗: 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

时间窗: 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".

次要结局

  • Empirical evidence of using PMT constructs in developing interventions(1 day)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Huso Yi

Assistant Professor

National University of Singapore

研究点 (1)

Loading locations...

相似试验