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Wellness Program Outreach and Effectiveness

Wellness Program Outreach and Effectiveness: A Randomized Controlled Trial

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06725511
Enrollment
2000
Registered
2024-12-10
Start date
2024-10-02
Completion date
2026-08-31
Last updated
2024-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metabolic Syndrome

Keywords

Metabolic Syndrome, Workplace wellness

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.

Detailed description

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.

Interventions

BEHAVIORALOpt-out framing

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

BEHAVIORALOpt-in framing

Eligible participants are invited to enroll

Sponsors

University of Illinois at Urbana-Champaign
CollaboratorOTHER
Quest Diagnostics-Nichols Insitute
CollaboratorINDUSTRY
Massachusetts Institute of Technology
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Probability of Engagement initiation12 monthsThe outcome is whether participants begin the program at some point during the Annual Risk Assessment year.

Secondary

MeasureTime frameDescription
Probability of Engagement level12 monthsNumber of modules completed during the Annual Risk Assessment year.
Probability of Retention at end of annual-risk-assessment year12 monthsIndicator the person is working for the firm on August 31, 2025
Annual Risk Assessment Measures: HbA1c24 monthsHbA1c the following year's Annual Risk Assessment
Annual Risk Assessment Measures: Weight24 monthsWeight measured in the following year's Annual Risk Assessment

Other

MeasureTime frameDescription
Mean number of Inpatient visits12 monthsNumber of inpatient visits during the Annual Risk Assessment year.
Mean number of outpatient visits12 monthsNumber of outpatient visits during the Annual Risk Assessment year.
Mean number of ED visits12 monthsNumber of emergency department visits during the Annual Risk Assessment year.
Mean total healthcare claims12 monthsTotal healthcare claims during the Annual Risk Assessment year.
Probability of full program engagement12 monthsIndicator for completing 9 modules during the Annual Risk Assessment year.
Probability of membership in the top 5% of healthcare claims12 monthsIndicator that the person is in the right tail of the distribution of claims.
Probability of membership in the top 1% of healthcare claims12 monthsIndicator that the person is in the right tail of the distribution of claims.

Countries

United States

Contacts

Primary ContactJoseph Doyle, PhD
jjdoyle@mit.edu6174523761
Backup ContactDavid Molitor, PhD
dmolitor@illinois.edu2172440504

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026