Wellness Program Outreach and Effectiveness

Massachusetts Institute of Technology (MIT)

Status: Enrolling

Conditions: Metabolic Syndrome

Treatments: Behavioral: Opt-in framing; Behavioral: Opt-out framing

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06725511

2402001204

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 2,000 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Provided informed consent.

2. 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)

Exclusion criteria

• 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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2,000 participants in 2 patient groups

Opt-in Outreach

Active Comparator group

Description:

Outreach notifies those eligible that they are invited to join the program, as usual practice.

Treatment:

Behavioral: Opt-in framing

Opt-out Outreach

Experimental group

Description:

Outreach notifies those eligible that they are enrolled in the program and invited to begin their first session.

Treatment:

Behavioral: Opt-out framing