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临床试验/NCT06752772
NCT06752772招募中不适用

WeArable teChnology daTa driVen digitAl healTh cOachINg (ACTIVATION)- A Mixed-methods Study

Alexandra Hospital1 个研究点 分布在 1 个国家目标入组 1,700 人开始时间: 2024年8月6日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
1,700
试验地点
1
主要终点
Changes in physical activity level

研究概览

简要总结

Public health priorities have shifted towards disease prevention, emphasising health promotion and lifestyle interventions to reduce disease burden. Despite global efforts, the prevalence of chronic diseases remains high, with lifestyle factors such as alcohol consumption, diet, smoking, obesity, and sedentary behaviour playing significant roles. In Singapore, suboptimal lifestyle behaviours are common, contributing to a high incidence of chronic conditions. Metabolic syndrome (MetS), linked to obesity, poses a growing societal burden due to its association with cardiovascular risks. Disparities exist in the delivery of lifestyle interventions among healthcare providers (HCPs), with many patients receiving inadequate guidance. Digital health coaching, incorporating wearable technology, offers promising solutions to bridge these gaps, providing personalised, real-time support and feedback to improve lifestyle behaviours and prevent disease progression. Challenges such as time constraints, lack of feedback, and limited support can be addressed through remote monitoring and tailored interventions, making scalable population-level interventions feasible.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
21 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 21-75 years old
  • Patients who are at risk of any of the following:
  • Elevated blood pressure
  • Overweight (BMI>=23kg/m2)
  • Pre-diabetes, OR
  • Patients who have one or more of the following (HOLD) conditions:
  • Hypertension
  • Obesity (BMI>=27.5kg/m2)
  • HyperLipidemia
  • Type 2 Diabetes Mellitus
  • Patients who own a smartphone
  • Patients who are willing to wear a smartwatch during the intervention period.

排除标准

  • Patients who have a medical condition that prevented participation in physical activity
  • Patients who have current diagnosis or history of eating disorder, depression
  • Patients who are currently pregnant or planning to become pregnant in the next 6 months
  • Patients who are currently participating in a weight loss programme (commercial, medically supervised, or research study)
  • Patients who are on weight loss medications (over-the-counter or prescription)
  • Patients who are not mentally-, physically- or technologically-capable
  • Patients who is unable to provide informed consent.

结局指标

主要结局

Changes in physical activity level

时间窗: Baseline, 6- and 12-month post study enrolment

Change in physical activity level will be measured using the International Physical Activity Questionnaire Short Form (IPAQ-SF) scale at baseline, 6- and 12-month post study enrolment. Higher score indicates a higher level of physical activity.

次要结局

  • Engagement and sustainability(Baseline, 3- , 6-, 9-, and 12-month post study enrolment)
  • Acceptability of the study(6-, 9- and 12-month post study enrolment)
  • Satisfaction towards the intervention provided(6-month post study enrolment)
  • Lifestyle changes (Diet)(Baseline, 6-, and 12-month post enrolment)
  • Lifestyle changes (Smoking Cessation)(Baseline, 6-, and 12-month post enrolment)
  • Lifestyle changes (Alcohol Cessation)(Baseline, 6-, and 12-month post enrolment)
  • Self-efficacy(Baseline, 6-, and 12-month post enrolment)
  • Quality of Life(Baseline, 6-, and 12-month post enrolment)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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