Actively Recruiting

Phase Not Applicable
Age: 21Years +
All Genders
ID06725511

Wellness Program Outreach and Effectiveness: A Randomized Controlled Trial

Led by Massachusetts Institute of Technology · Updated on 2024-12-10

2000

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

Sponsors

M

Massachusetts Institute of Technology

Lead Sponsor

U

University of Illinois at Urbana-Champaign

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating an outreach campaign to increase participation in Pack Health, a wellness program by Quest Diagnostics that offers personalized health coaching for weight management and diabetes prevention. The study focuses on employees and their spouses or domestic partners who have metabolic syndrome, a condition defined by having three or more specific risk factors. The goal is to see if automatically enrolling eligible individuals, with the option to opt out, improves engagement and health outcomes compared to the usual invitation-based approach. Participants are randomly assigned to one of two groups: the intervention group receives outreach that automatically enrolls them in the program and invites them to begin their first session, while the control group receives the standard invitation to join. The study compares these two outreach methods over time to determine which leads to higher engagement and better health results. During the study, researchers will track how many participants start and continue the program, the number of program modules completed, changes in health measures like HbA1c and weight over two years, and employee retention after one year. The main measurement is the likelihood that participants begin the program within 12 months. The study will run until August 2026, with ongoing assessments through healthcare claims and risk evaluations to monitor outcomes and program effectiveness.

CONDITIONS

Brief Title

Wellness Program Outreach and Effectiveness

Who Can Participate

Age: 21Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Provided informed consent.
  • Employees, spouses, or domestic partners over the age of 18 eligible for the Pack Health program.
  • Diagnosed with metabolic syndrome having at least three of the following: high waist circumference (>35 inches for women, >40 inches for men), high triglycerides (≥150 mg/dl), low HDL cholesterol (<50 mg/dl for women, <40 mg/dl for men), high blood pressure (≥130/85), high fasting glucose (≥100 mg/dl).
Not Eligible

You will not qualify if you...

  • Under the age of 21.
  • History of anorexia nervosa.
  • History of bulimia nervosa.
  • History of binge-eating disorder.
  • History of body dysmorphic disorder.
  • History of major depression.
  • History of post-traumatic stress disorder (PTSD).
  • History of severe anxiety disorder.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person or virtual)

Outreach and Program Enrollment

Duration - Initial outreach period with ongoing opportunity to start the program up to 12 months

Participants are randomly assigned to receive either opt-in or opt-out outreach to join the wellness program and begin participation.

Outreach notifications and program sessions conducted remotely

Program Participation and Monitoring

Duration - Up to 12 months

Participants engage with the Pack Health wellness program for weight management and diabetes prevention, with progress tracked through program engagement and health assessments.

Regular remote sessions and health assessments as part of the program

Health Outcomes Assessment

Duration - Up to 24 months

Participants have annual risk assessments to measure health outcomes such as HbA1c and weight to evaluate the impact of the wellness program.

Annual health assessments

Trial Site Locations

Total: 1 location

1

Quest Diagnostics

Secaucus, New Jersey, United States, 07094

Actively Recruiting

Loading map...

Research Team

J

Joseph Doyle, PhD

D

David Molitor, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

HEALTH_SERVICES_RESEARCH

Number of Arms

2

Similar Trials

Nutritional Approach for the Transformation and Reduction of...

Metabolic Syndrome

Actively Recruiting

1 location

Primary Prevention Study of Cardiovascular Diseases and Diab...

Metabolic Syndrome

Actively Recruiting

1 location

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here