Wellness Program Outreach and Effectiveness

Официальное название

Wellness Program Outreach and Effectiveness: A Randomized Controlled Trial

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое Opt-out framing
  Outreach notifies those eligible that they are enrolled in the program and invites them to start participating.
• Поведенческое Opt-in framing
  Eligible participants are invited to enroll

Первичные конечные точки

• Probability of Engagement initiation [Срок оценки: 12 months]

Вторичные конечные точки (4)

• Probability of Engagement level [Срок оценки: 12 months]
• Probability of Retention at end of annual-risk-assessment year [Срок оценки: 12 months]
• Annual Risk Assessment Measures: HbA1c [Срок оценки: 24 months]
• Annual Risk Assessment Measures: Weight [Срок оценки: 24 months]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• 1\. Anyone under the age of 21. They will not be part of the study and will receive messages as if they were in the control group.

2\. 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Организация здравоохранения

Центры проведения

США · 1 центр

• Quest Diagnostics — Secaucus

Идентификаторы

NCT: NCT06725511 · 2402001204

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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