Wellness Program Outreach and Effectiveness
ConditionMetabolic Syndrome
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21+
SponsorMassachusetts Institute of Technology
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Provided informed consent.
Employees/spouses/domestic partners over the age of 18
High waist circumference (>35 inches for women and >40 inches for men)
High triglycerides (≥150 mg/dl)
Disqualifiers
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.
Anorexia nervosa
Bulimia nervosa
Binge-eating disorder
Trial design
Design model
Parallel
Treatments tested in this trial
Opt-out framing
BehavioralOutreach notifies those eligible that they are enrolled in the program and invites them to start participating.
Opt-in framing
BehavioralEligible participants are invited to enroll
Treatment groups
2,000 Participants
are divided into 2 treatment groupsGroup A: Opt-in OutreachActive comparator 1 intervention
Group B: Opt-out OutreachExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Probability of Engagement initiation
The outcome is whether participants begin the program at some point during the Annual Risk Assessment year.
Time frame
12 monthsSecondary outcomes
1
Probability of Engagement level
Number of modules completed during the Annual Risk Assessment year.
Time frame
12 months2
Probability of Retention at end of annual-risk-assessment year
Indicator the person is working for the firm on August 31, 2025
Time frame
12 months3
Annual Risk Assessment Measures: HbA1c
HbA1c the following year's Annual Risk Assessment
Time frame
24 months4
Annual Risk Assessment Measures: Weight
Weight measured in the following year's Annual Risk Assessment
Time frame
24 monthsOther outcomes
1
Probability of full program engagement
Indicator for completing 9 modules during the Annual Risk Assessment year.
Time frame
12 months2
Probability of membership in the top 5% of healthcare claims
Indicator that the person is in the right tail of the distribution of claims.
Time frame
12 months3
Probability of membership in the top 1% of healthcare claims
Indicator that the person is in the right tail of the distribution of claims.
Time frame
12 months4
Mean number of Inpatient visits
Number of inpatient visits during the Annual Risk Assessment year.
Time frame
12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Massachusetts Institute of Technology
Lead sponsor
University of Illinois at Urbana-Champaign
Collaborator
Quest Diagnostics-Nichols Insitute
Collaborator
Source ClinicalTrials.gov