Wellness Program Outreach and Effectiveness

NCT06725511 | Recruiting

• 1 other identifier: 2402001204
• Study Type: interventional
• Target: 2,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Metabolic Syndrome

Keywords

Metabolic Syndrome; Workplace wellness

Outcome Measures

Primary Outcomes (1)

• Probability of Engagement initiation

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

  12 months

Secondary Outcomes (4)

• 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

Other Outcomes (7)

• Probability of full program engagement

  12 months

• Probability of membership in the top 5% of healthcare claims

  12 months

• Probability of membership in the top 1% of healthcare claims

  12 months

Study Arms (2)

Opt-in Outreach

ACTIVE COMPARATOR

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

Behavioral: Opt-in framing

Opt-out Outreach

EXPERIMENTAL

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

Behavioral: Opt-out framing

Interventions

Opt-out framing BEHAVIORAL

Outreach notifies those eligible that they are enrolled in the program and invites them to start participating.

Opt-out Outreach

Opt-in framing BEHAVIORAL

Eligible participants are invited to enroll

Opt-in Outreach

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• \. 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.
• \. 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

Sponsors & Collaborators

• Massachusetts Institute of Technology: lead
• University of Illinois at Urbana-Champaign: collaborator
• Quest Diagnostics-Nichols Insitute: collaborator

Study Sites (1)

Quest Diagnostics

Secaucus, New Jersey, 07094, United States

RECRUITING

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Joseph Doyle, PhD

  MIT Sloan School of Management

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joseph Doyle, PhD

CONTACT

6174523761; jjdoyle@mit.edu

David Molitor, PhD

CONTACT

2172440504; dmolitor@illinois.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2024
• First Posted: December 10, 2024
• Study Start: October 2, 2024
• Primary Completion: August 31, 2025
• Study Completion (Estimated): August 31, 2026
• Last Updated: December 10, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)