Wellness Program Outreach and Effectiveness

Not Applicable

Recruiting

• Conditions: Metabolic Syndrome

• Registration Number: NCT06725511
• Lead Sponsor: Massachusetts Institute of Technology

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2024-10-02
• Study First Submitted: 2024-11-22
• Status Verified: 2024-12
• Study First Submitted QC: 2024-12-04
• Last Update Submitted: 2024-12-04
• Study First Posted: 2024-12-10
• Last Update Posted: 2024-12-10
• Primary Completion: 2025-08-31
• Study Completion: 2026-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2000

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Probability of Engagement initiation	12 months	The outcome is whether participants begin the program at some point during the Annual Risk Assessment year.

Secondary Outcome Measures

Name	Time	Method
Probability of Engagement level	12 months	Number of modules completed during the Annual Risk Assessment year.
Probability of Retention at end of annual-risk-assessment year	12 months	Indicator the person is working for the firm on August 31, 2025
Annual Risk Assessment Measures: HbA1c	24 months	HbA1c the following year's Annual Risk Assessment
Annual Risk Assessment Measures: Weight	24 months	Weight measured in the following year's Annual Risk Assessment

Trial Locations

Locations (1)

Quest Diagnostics; 🇺🇸 Secaucus, New Jersey, United States