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Clinical Trials/NCT06725511
NCT06725511
Recruiting
N/A

Wellness Program Outreach and Effectiveness: A Randomized Controlled Trial

Massachusetts Institute of Technology1 site in 1 country2,000 target enrollmentOctober 2, 2024

Overview

Phase
N/A
Intervention
Not specified
Conditions
Metabolic Syndrome
Sponsor
Massachusetts Institute of Technology
Enrollment
2000
Locations
1
Primary Endpoint
Probability of Engagement initiation
Status
Recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 2, 2024
End Date
August 31, 2026
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

  • Anyone under the age of
  • 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

Outcomes

Primary Outcomes

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

  • Probability of Engagement level(12 months)
  • Probability of Retention at end of annual-risk-assessment year(12 months)
  • Annual Risk Assessment Measures: HbA1c(24 months)
  • Annual Risk Assessment Measures: Weight(24 months)

Study Sites (1)

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