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临床试验/NCT06725511
NCT06725511招募中不适用

Wellness Program Outreach and Effectiveness: A Randomized Controlled Trial

Massachusetts Institute of Technology2 个研究点 分布在 1 个国家目标入组 2,000 人开始时间: 2024年10月2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
2,000
试验地点
2
主要终点
Probability of Engagement initiation

研究概览

简要总结

The investigators will conduct a randomized controlled trial to evaluate the impact of an outreach campaign designed to increase engagement with Pack Health, a Quest Diagnostics wellness program providing individual health coaching for weight management and diabetes prevention. While employee wellness and disease-management programs have the potential to improve wellbeing and reduce healthcare costs, their effectiveness is often undermined by low engagement and selection bias in participant comparisons. This study will test whether an outreach approach that auto-enrolls eligible individuals-employees and their spouses/domestic partners-into the program, with the option to opt out, can increase engagement and improve health outcomes compared to the standard invitation-based approach.

详细描述

The investigators will conduct a randomized controlled trial to evaluate the impact of an outreach campaign designed to increase engagement with Pack Health, a Quest Diagnostics wellness program providing individual health coaching for weight management and diabetes prevention. While employee wellness and disease-management programs have the potential to improve wellbeing and reduce healthcare costs, their effectiveness is often undermined by low engagement and selection bias in participant comparisons. This study will test whether an outreach approach that auto-enrolls eligible individuals-employees and their spouses/domestic partners-into the program, with the option to opt out, can increase engagement and improve health outcomes compared to the standard invitation-based approach.

Participants will be randomly assigned to one of two groups: the intervention group, which will receive auto-enrollment outreach, and the control group, which will receive traditional invitation-based outreach. The primary outcome will measure program engagement as the share who begin the program. Secondary outcomes will include additional measures of engagement, such as the number of modules completed, health outcomes observed in subsequent risk assessments and healthcare claims, and employee retention. This trial will provide evidence on whether an opt-out framing in outreach campaigns can enhance the effectiveness of wellness programs, ultimately informing best practices for population health management.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

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

入选标准

  • Provided informed consent.
  • Those who are eligible for the Pack Health program:
  • Employees/spouses/domestic partners over the age of 18
  • Metabolic syndrome defined as results indicating 3 or more of the following risk factors:
  • High waist circumference (>35 inches for women and >40 inches for men)
  • High triglycerides (≥150 mg/dl)
  • Low HDL cholesterol (<50 mg/dl for women and <40 mg/dl for men)
  • High Blood Pressure (≥130/85)
  • High Fasting Glucose (≥100 mg/dl)

排除标准

  • Anyone under the age of
  • They will not be part of the study and will receive messages as if they were in the control group.
  • Anyone observed in claims data with a historical diagnosis of:
  • Anorexia nervosa
  • Bulimia nervosa
  • Binge-eating disorder
  • Body dysmorphic disorder
  • Major depression
  • Post-traumatic stress disorder (PTSD)
  • Severe anxiety disorder

结局指标

主要结局

Probability of Engagement initiation

时间窗: 12 months

The outcome is whether participants begin the program at some point during the Annual Risk Assessment year.

次要结局

  • Probability of Engagement level(12 months)
  • Probability of Retention at end of annual-risk-assessment year(12 months)
  • Annual Risk Assessment Measures: HbA1c(24 months)
  • Annual Risk Assessment Measures: Weight(24 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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