Outreach program to improve engagement in a wellness initiative for metabolic syndrome
Wellness Program Outreach and Effectiveness: A Randomized Controlled Trial
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 2000 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | Massachusetts Institute of Technology Academic / other |
| Locations | 1 site (Secaucus, New Jersey) |
| Trial ID | NCT06725511 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include employees and their spouses/domestic partners over the age of 18 who meet the criteria for metabolic syndrome.
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.
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 performed: Other studies have shown that innovative outreach methods can improve engagement in health programs, suggesting potential success for this approach.
Eligibility criteria
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 this trial is running
Secaucus, New Jersey
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.