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Wellness Program Outreach and Effectiveness

NCT ID: NCT06725511

Last Updated: 2024-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

2000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-02

Study Completion Date

2026-08-31

Brief Summary

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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

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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.

Conditions

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Metabolic Syndrome

Keywords

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Metabolic Syndrome Workplace wellness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Opt-in Outreach

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

Group Type ACTIVE_COMPARATOR

Opt-in framing

Intervention Type BEHAVIORAL

Eligible participants are invited to enroll

Opt-out Outreach

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

Group Type EXPERIMENTAL

Opt-out framing

Intervention Type BEHAVIORAL

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

Interventions

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Opt-out framing

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

Intervention Type BEHAVIORAL

Opt-in framing

Eligible participants are invited to enroll

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Illinois at Urbana-Champaign

OTHER

Sponsor Role collaborator

Quest Diagnostics-Nichols Insitute

INDUSTRY

Sponsor Role collaborator

Massachusetts Institute of Technology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Joseph Doyle, PhD

Role: PRINCIPAL_INVESTIGATOR

MIT Sloan School of Management

Locations

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Quest Diagnostics

Secaucus, New Jersey, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Joseph Doyle, PhD

Role: CONTACT

Phone: 6174523761

Email: [email protected]

David Molitor, PhD

Role: CONTACT

Phone: 2172440504

Email: [email protected]

Facility Contacts

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Nicholas Torsiello, PhD MPH

Role: primary

Karen Liptak-Soriano, BS

Role: backup

Provided Documents

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Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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2402001204

Identifier Type: -

Identifier Source: org_study_id