Metabolic SyndromeNCT06725511
Wellness Program Outreach and Effectiveness
A study testing Opt-out framing and Opt-in framing in people with Metabolic Syndrome, run by Massachusetts Institute of Technology at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- Opt-out framing and Opt-in framing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,000 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Oct 2024to 31 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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)
Who cannot join
- 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
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- Major depression
- Post-traumatic stress disorder (PTSD)
- Severe anxiety disorder
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Quest Diagnostics
Secaucus, New Jersey, 07094
Nicholas Torsiello, PhD MPH, 914-450-7162, nicholas.e.torsiello@questdiagnostics.com
Karen Liptak-Soriano, BS, 914-450-7162, karen.m.liptak-soriano@questdiagnostics.com
About this study
Official title: Wellness Program Outreach and Effectiveness: A Randomized Controlled 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.
Read the 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.
- Conditions
- Metabolic Syndrome
- Being tested
- Opt-out framing, Opt-in framing
- Keywords
- Metabolic Syndrome, Workplace wellness
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Opt-out framingBehavioural
Outreach notifies those eligible that they are enrolled in the program and invites them to start participating.
Opt-in framingBehavioural
Eligible participants are invited to enroll
| Study group | Role | What they receive |
|---|---|---|
| Opt-in Outreach | Active comparator | Outreach notifies those eligible that they are invited to join the program, as usual practice. Receives: Behavioral: Opt-in framing |
| Opt-out Outreach | Experimental | Outreach notifies those eligible that they are enrolled in the program and invited to begin their first session. Receives: Behavioral: Opt-out framing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Probability of Engagement initiation
The outcome is whether participants begin the program at some point during the Annual Risk Assessment year.
Measured: 12 months
Secondary outcomes (4)
Probability of Engagement level
Number of modules completed during the Annual Risk Assessment year.
Measured: 12 months
Probability of Retention at end of annual-risk-assessment year
Indicator the person is working for the firm on August 31, 2025
Measured: 12 months
Annual Risk Assessment Measures: HbA1c
HbA1c the following year's Annual Risk Assessment
Measured: 24 months
Annual Risk Assessment Measures: Weight
Weight measured in the following year's Annual Risk Assessment
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2024
- Study start2 Oct 2024
- Primary completion31 Aug 2025 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts Institute of Technology
- Sponsor type
- University, hospital or other
- Collaborators
- University of Illinois at Urbana-Champaign, Quest Diagnostics-Nichols Insitute
- Responsible party
- Sponsor
- Investigators
- Joseph Doyle, PhD, Principal investigator, MIT Sloan School of Management
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06725511
- Sponsor's protocol ID
- 2402001204
- Status last verified
- Dec 2024
- First submitted
- 22 Nov 2024
- Last updated
- 10 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Subject to approval from implementation partner.
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wellness Program Outreach and Effectiveness: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06725511
- Acronym / sponsor ID
- 2402001204
- Conditions
- Metabolic Syndrome
- Keywords
- Metabolic Syndrome, Workplace wellness
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Massachusetts Institute of TechnologyUniversity, hospital or other
- Collaborators
- University of Illinois at Urbana-Champaign, Quest Diagnostics-Nichols Insitute
- Study start
- 2 Oct 2024 (actual)
- Primary completion
- 31 Aug 2025 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 10 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Opt-in Outreach | Active comparator | Behavioral: Opt-in framingOutreach notifies those eligible that they are invited to join the program, as usual practice. |
| Opt-out Outreach | Experimental | Behavioral: Opt-out framingOutreach notifies those eligible that they are enrolled in the program and invited to begin their first session. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Provided informed consent.
- Those who are eligible for the Pack Health program:
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Opt-out framingOutreach notifies those eligible that they are enrolled in the program and invites them to start participating. | Behavioural | Opt-out Outreach |
| Opt-in framingEligible participants are invited to enroll | Behavioural | Opt-in Outreach |
Primary outcome
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.
4 secondary outcomes
Probability of Engagement level
Time frame: 12 months
Probability of Retention at end of annual-risk-assessment year
Time frame: 12 months
Annual Risk Assessment Measures: HbA1c
Time frame: 24 months
Annual Risk Assessment Measures: Weight
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2024.
- Individual participant dataSharing planned: No. Subject to approval from implementation partner.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Joseph Doyle, PhD principal investigator
MIT Sloan School of Management
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Opt-out framing and Opt-in framing in people with Metabolic Syndrome, run by Massachusetts Institute of Technology at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joseph Doyle, PhD (6174523761, jjdoyle@mit.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Probability of Engagement initiation (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2024.