Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06725511

Wellness Program Outreach and Effectiveness

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

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.
  • 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

Treatment and study plan

Opt-out framing

Behavioral

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

Opt-in framing

Behavioral

Eligible participants are invited to enroll

Primary outcomes

  1. Probability of Engagement initiation

    Time frame: 12 months

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

Secondary outcomes

  1. Probability of Engagement level

    Time frame: 12 months

    Number of modules completed during the Annual Risk Assessment year.

  2. Probability of Retention at end of annual-risk-assessment year

    Time frame: 12 months

    Indicator the person is working for the firm on August 31, 2025

  3. Annual Risk Assessment Measures: HbA1c

    Time frame: 24 months

    HbA1c the following year's Annual Risk Assessment

  4. Annual Risk Assessment Measures: Weight

    Time frame: 24 months

    Weight measured in the following year's Annual Risk Assessment

Other outcomes

  1. Probability of full program engagement

    Time frame: 12 months

    Indicator for completing 9 modules during the Annual Risk Assessment year.

  2. Probability of membership in the top 5% of healthcare claims

    Time frame: 12 months

    Indicator that the person is in the right tail of the distribution of claims.

  3. Probability of membership in the top 1% of healthcare claims

    Time frame: 12 months

    Indicator that the person is in the right tail of the distribution of claims.

  4. Mean number of Inpatient visits

    Time frame: 12 months

    Number of inpatient visits during the Annual Risk Assessment year.

  5. Mean number of ED visits

    Time frame: 12 months

    Number of emergency department visits during the Annual Risk Assessment year.

  6. Mean number of outpatient visits

    Time frame: 12 months

    Number of outpatient visits during the Annual Risk Assessment year.

  7. Mean total healthcare claims

    Time frame: 12 months

    Total healthcare claims during the Annual Risk Assessment year.

Study contacts

Contact information is provided by the study sponsor or research team.

David Molitor, PhD

CONTACT

[email protected]

2172440504

Joseph Doyle, PhD

CONTACT

[email protected]

6174523761

Sponsors and collaborators

Lead sponsor

Massachusetts Institute of Technology

Other

Collaborators

  • Quest Diagnostics-Nichols Insitute
  • University of Illinois at Urbana-Champaign

Registry information

Official study title

Wellness Program Outreach and Effectiveness: A Randomized Controlled Trial

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Dec 10, 2024
Registry last updated
Dec 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.