Clinical trial NCT06725511: Wellness Program Outreach and Effectiveness
Official title: Wellness Program Outreach and Effectiveness: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Metabolic Syndrome
Keywords: Metabolic Syndrome
Workplace wellness
Lead sponsor: Massachusetts Institute of Technology
Sponsor class: OTHER
Collaborators: name: University of Illinois at Urbana-Champaign
name: Quest Diagnostics-Nichols Insitute
First posted: 2024-12-10
Enrollment: 2000
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Probability of Engagement initiation
timeFrame: 12 months
Secondary outcomes:
measure: Probability of Engagement level
timeFrame: 12 months
measure: Probability of Retention at end of annual-risk-assessment year
timeFrame: 12 months
measure: Annual Risk Assessment Measures: HbA1c
timeFrame: 24 months
measure: Annual Risk Assessment Measures: Weight
timeFrame: 24 months
Other outcomes:
measure: Probability of full program engagement
timeFrame: 12 months
measure: Probability of membership in the top 5% of healthcare claims
timeFrame: 12 months
measure: Probability of membership in the top 1% of healthcare claims
timeFrame: 12 months
measure: Mean number of Inpatient visits
timeFrame: 12 months
measure: Mean number of ED visits
timeFrame: 12 months
measure: Mean number of outpatient visits
timeFrame: 12 months
measure: Mean total healthcare claims
timeFrame: 12 months
Locations:
city: Secaucus
country: United States
facility: Quest Diagnostics
state: New Jersey
Study officials:
affiliation: MIT Sloan School of Management
name: Joseph Doyle, PhD
role: PRINCIPAL_INVESTIGATOR
References: