NCT06725511 · Massachusetts Institute of Technology
Wellness Program Outreach and Effectiveness
What this study is about
The investigators will conduct a randomly assigned 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.
View original scientific 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.
Interventions
BEHAVIORAL
Opt-out framing
Outreach notifies those eligible that they are enrolled in the program and invites them to start participating.
BEHAVIORAL
Opt-in framing
Eligible participants are invited to enroll
Primary outcome measures
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- 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
- Secaucus, New Jersey
Collaborators
University of Illinois at Urbana-Champaign, Quest Diagnostics-Nichols Insitute
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Dec 10, 2024 · Source of record for eligibility and locations