Outreach program to improve engagement in a wellness initiative for metabolic syndrome
Official title: Wellness Program Outreach and Effectiveness: A Randomized Controlled Trial
Run by Massachusetts Institute of Technology · NCT06725511 · Data updated 2026-11-12
This study is testing if a new way of inviting people to join a wellness program can help those with metabolic syndrome get better support for weight management and diabetes prevention.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 21 Years and up |
| Sex | All |
| Enrollment | 2000 (estimated) |
| Sponsor | Massachusetts Institute of Technology Academic / other |
| Locations | 1 site (Secaucus, New Jersey) |
| Status | Recruiting |
| Started | October 2, 2024 |
| Main results expected | August 31, 2025 |
| Study ends | August 31, 2026 |
| Registry record updated | December 10, 2024 |
| Trial ID | NCT06725511 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include employees and their spouses/domestic partners over the age of 18 who meet the criteria for metabolic syndrome.
✕Probably not a fit
Patients under the age of 21 or those with a history of certain eating disorders or severe mental health conditions may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial evaluates the effectiveness of an outreach campaign aimed at increasing participation in the Pack Health wellness program, which offers individual health coaching for weight management and diabetes prevention. Participants will be randomly assigned to either an intervention group that receives auto-enrollment outreach or a control group that receives traditional invitation-based outreach. The study will measure program engagement and health outcomes, including risk assessments and healthcare claims, to determine if an opt-out approach enhances participation compared to standard methods. The findings aim to inform best practices for improving population health through wellness programs.
Why it matters
Potential benefit: If successful, this program could significantly enhance engagement in wellness initiatives, leading to better health outcomes for individuals with metabolic syndrome.
How similar studies have gone: Other studies have shown that innovative outreach methods can improve engagement in health programs, suggesting potential success for this approach.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Quest Diagnostics
Secaucus, New Jersey, United States Recruiting
Study contacts
- Principal investigator: Joseph Doyle, PhD — MIT Sloan School of Management
- Study coordinator: Joseph Doyle, PhD
- Email: jjdoyle@mit.edu
- Phone: 6174523761
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.