Recruiting

Wellness Program

Sponsor:

Massachusetts Institute of Technology

Code:

NCT06725511

Conditions

Metabolic Syndrome

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Interventions

Opt-out framing

Opt-in framing

Study Details

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

Study ID

NCT06725511

Start date

Oct 2, 2024

Status verified date

Dec, 2024

Completion date

Aug 31, 2026

Anticipated

Primary completion date

Aug 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

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

Enrollment

2000 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

active comparator: Opt-in Outreach

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

experimental: Opt-out Outreach

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

Interventions

Opt-out framing

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

Opt-in framing

Eligible participants are invited to enroll

Primary outcome measure

  • Probability of Engagement initiation [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Joseph Doyle, PhD

6174523761jjdoyle@mit.edu

David Molitor, PhD

2172440504dmolitor@illinois.edu

Locations

Quest Diagnostics

Recruiting

Secaucus, New Jersey, United States, 07094

Contacts

Nicholas Torsiello, PhD MPH

914-450-7162nicholas.e.torsiello@questdiagnostics.com

Karen Liptak-Soriano, BS

914-450-7162karen.m.liptak-soriano@questdiagnostics.com

Principal Investigator:

Nicholas Torsiello, PhD

More Information

Sponsor

Massachusetts Institute of Technology

Last update posted

Dec 10, 2024

Last verified

Dec, 2024

Keywords

  • Metabolic Syndrome
  • Workplace wellness

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts Institute of Technology on 2024-12-10.