Wellness Program Outreach and Effectiveness

Wellness Program Outreach and Effectiveness: A Randomized Controlled Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Metabolic Syndrome
• Intervention / Treatment: Behavioral: Opt-in framing; Behavioral: Opt-out framing

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 Type: Interventional
• Enrollment (Estimated): 2000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Joseph Doyle, PhD; Phone Number: 6174523761; Email: jjdoyle@mit.edu
• Study Contact Backup: Name: David Molitor, PhD; Phone Number: 2172440504; Email: dmolitor@illinois.edu

Study Locations

• United States
  • New Jersey
    • Secaucus, New Jersey, United States, 07094
      • Recruiting
      • Quest Diagnostics
      • Contact: Nicholas Torsiello, PhD MPH; Phone Number: 914-450-7162; Email: nicholas.e.torsiello@questdiagnostics.com
      • Contact: Karen Liptak-Soriano, BS; Phone Number: 914-450-7162; Email: karen.m.liptak-soriano@questdiagnostics.com
      • Principal Investigator: Nicholas Torsiello, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Opt-in Outreach; Outreach notifies those eligible that they are invited to join the program, as usual practice.	Behavioral: Opt-in framing; Eligible participants are invited to enroll
Experimental: Opt-out Outreach; Outreach notifies those eligible that they are enrolled in the program and invited to begin their first session.	Behavioral: Opt-out framing; Outreach notifies those eligible that they are enrolled in the program and invites them to start participating.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Probability of full program engagement	Indicator for completing 9 modules during the Annual Risk Assessment year.	12 months
Probability of membership in the top 5% of healthcare claims	Indicator that the person is in the right tail of the distribution of claims.	12 months
Probability of membership in the top 1% of healthcare claims	Indicator that the person is in the right tail of the distribution of claims.	12 months
Mean number of Inpatient visits	Number of inpatient visits during the Annual Risk Assessment year.	12 months
Mean number of ED visits	Number of emergency department visits during the Annual Risk Assessment year.	12 months
Mean number of outpatient visits	Number of outpatient visits during the Annual Risk Assessment year.	12 months
Mean total healthcare claims	Total healthcare claims during the Annual Risk Assessment year.	12 months

Collaborators and Investigators

• Sponsor: Massachusetts Institute of Technology
• Collaborators: University of Illinois at Urbana-Champaign; Quest Diagnostics-Nichols Insitute
• Investigators: Principal Investigator: Joseph Doyle, PhD, MIT Sloan School of Management

Study record dates

Study Major Dates

• Study Start (Actual): October 2, 2024
• Primary Completion (Estimated): August 31, 2025
• Study Completion (Estimated): August 31, 2026

Study Registration Dates

• First Submitted: November 22, 2024
• First Submitted That Met QC Criteria: December 4, 2024
• First Posted (Estimated): December 10, 2024

Study Record Updates

• Last Update Posted (Estimated): December 10, 2024
• Last Update Submitted That Met QC Criteria: December 4, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Metabolic Syndrome; Workplace wellness
• Additional Relevant MeSH Terms: Metabolic Diseases; Glucose Metabolism Disorders; Insulin Resistance; Hyperinsulinism; Metabolic Syndrome
• Other Study ID Numbers: 2402001204

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Subject to approval from implementation partner.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No