Wellness Program Outreach and Effectiveness
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Opt-out framing, Opt-in framing.
- Who it may be relevant to
- Registry conditions: Metabolic Syndrome. Basic parameters: from 21 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Wellness Program Outreach and Effectiveness: A Randomized Controlled Trial
Overview
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.
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]
Secondary outcome measures (4)
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Health services research
Study locations
United States · 1 center
- Quest Diagnostics — Secaucus
Identifiers
NCT: NCT06725511 · 2402001204