Enrollment Strategies for Metabolic Syndrome

Overseen By David Molitor, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts Institute of Technology

Disqualifiers: Anorexia, Bulimia, Binge-eating, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

2000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to boost participation in a wellness program for weight management and diabetes prevention. It compares two approaches: one where eligible individuals receive an invitation to join, and another where they are automatically enrolled with the option to opt out. The trial seeks employees or their spouses/domestic partners with metabolic syndrome, which may include a large waistline, high blood pressure, or high blood sugar. Participants should have experience with these health issues in their daily lives. As an unphased trial, this study provides a unique opportunity to contribute to innovative wellness strategies that could benefit many.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to consult with the trial coordinators or your healthcare provider for guidance.

What prior data suggests that this outreach strategy is safe?

Research shows that wellness programs like the one in this study are generally safe for participants. These programs involve health coaching and lifestyle changes, which are non-invasive and carry minimal risk. Although specific safety data for this trial is not yet available, similar programs typically report few, if any, negative effects. This trial is in the "Not Applicable" phase, indicating it doesn't involve testing a new drug or device, which usually means lower risk. The study focuses more on how people join the program rather than the program's safety itself. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative ways to engage people with metabolic syndrome in wellness programs. Traditional approaches often rely on individuals opting in, which can limit participation. This trial compares the usual opt-in method with an opt-out approach, where eligible individuals are automatically enrolled and simply invited to start. This could significantly increase participation and, subsequently, the effectiveness of wellness interventions. By testing these two methods, researchers hope to discover more efficient ways to boost engagement and improve health outcomes for those with metabolic syndrome.

What evidence suggests that this trial's outreach strategies could be effective for increasing engagement in wellness programs?

Research has shown that wellness programs like Pack Health can aid in weight control and diabetes prevention. Studies have found that increased participation in these programs often leads to improved health outcomes. In this trial, participants will be divided into two groups: one using an opt-out approach, where individuals are automatically enrolled unless they choose not to participate, and another using the usual opt-in method, where individuals are invited to join. Early findings suggest that the opt-out method could result in higher participation compared to the opt-in method. Greater participation typically leads to better results in managing health issues like metabolic syndrome. ^{1 2 3 4 6}

Who Is on the Research Team?

Joseph Doyle, PhD

Principal Investigator

MIT Sloan School of Management

Are You a Good Fit for This Trial?

This trial is for employees and their spouses or domestic partners who are eligible to participate in Pack Health, a wellness program aimed at weight management and diabetes prevention. The study will test if automatically enrolling people with the option to opt out increases engagement compared to just inviting them.

Inclusion Criteria

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)

Provided informed consent

Exclusion Criteria

I am under 21 years old.

I have a history of an eating disorder, body dysmorphic disorder, major depression, PTSD, or severe anxiety.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants are randomly assigned to either the opt-in or opt-out outreach group to evaluate engagement with the wellness program

12 months

Annual Risk Assessment visits

Follow-up

Participants are monitored for engagement levels and health outcomes, including risk assessments and healthcare claims

12 months

Extended Follow-up

Additional health outcomes such as HbA1c and weight are assessed in the following year's Annual Risk Assessment

24 months

What Are the Treatments Tested in This Trial?

Interventions

• Wellness Program Outreach

Trial Overview The trial is testing two different ways of getting people involved in the wellness program: 'Opt-in framing' where participants choose to join, and 'Opt-out framing' where they're enrolled by default but can leave if they want. It's a randomized controlled trial, meaning people are put into these groups by chance.

How Is the Trial Designed?

Group I: Opt-out Outreach Experimental Treatment 1 Intervention

Outreach notifies those eligible that they are enrolled in the program and invited to begin their first session.

Group II: Opt-in Outreach Active Control 1 Intervention

Outreach notifies those eligible that they are invited to join the program, as usual practice.

Who Is Running the Clinical Trial?

Massachusetts Institute of Technology

Lead Sponsor

Trials

104

Recruited

12,810,000+

University of Illinois at Urbana-Champaign

Collaborator

Trials

203

Recruited

40,600+

Quest Diagnostics-Nichols Insitute

Industry Sponsor

Trials

14

Recruited

26,500+

Published Research Related to This Trial

A study of 153 insured adults with metabolic syndrome found that increasing insurance coverage for weight management programs significantly boosted interest in participation, with a threefold increase for women and a sevenfold increase for men when coverage rose from 10% to 100%.

Most participants supported financial incentives for weight loss, with 76% of women and 57% of men expressing interest, suggesting that such incentives could effectively motivate individuals to engage in weight management programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Insurance coverage and incentives for weight loss among adults with metabolic syndrome. Arterburn, D., Westbrook, EO., Wiese, CJ., et al.[2017]

A two-day education program for patients with metabolic syndrome (MetS) led to significant improvements in health indicators, including reduced waist circumference and increased high-density lipoprotein (HDL) cholesterol levels after 6 months.

The program also enhanced quality of life and reduced depression and anxiety levels, with three out of twenty-two participants no longer meeting MetS criteria by the end of the study, highlighting the program's potential efficacy in managing MetS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Temporal Changes of Metabolic Indicators and Quality of Life by a Two-Day Patient Education Program for Metabolic Syndrome Patients. Jeon, JS., Lee, SY., Ahn, SC., et al.[2022]

A 10-week voluntary workplace weight loss program involving 3880 participants led to significant weight loss, with women losing an average of 9.4 pounds and men 13.2 pounds, contributing to improved health outcomes.

The program also significantly reduced the prevalence of metabolic syndrome from 43% to 30% in women and from 52% to 26% in men, indicating its effectiveness in addressing metabolic health risks in employees.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a Voluntary Worksite Weight Loss Program on Metabolic Syndrome. Earnest, CP., Church, TS.[2017]

The Met Fit program, a 12-week lifestyle intervention for metabolic syndrome, showed significant effectiveness, with 19.4% of participants no longer meeting the criteria for metabolic syndrome by the end of the program.

Out of 126 enrolled patients, those who completed the program experienced an average weight loss of 6.2 lbs, along with significant reductions in waist circumference, body fat, and blood pressure, indicating substantial health improvements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The metabolic fitness program: lifestyle modification for the metabolic syndrome using the resources of cardiac rehabilitation. Rubenfire, M., Mollo, L., Krishnan, S., et al.[2022]

The Healthy Fit program effectively reached 514 low-income Hispanic immigrants, providing them with health screenings and resources to access preventive services, which is crucial given their high rates of obesity and related health disparities.

Post-intervention, significant percentages of participants engaged in health screenings (54% for breast cancer, 43% for cervical cancer, and 32% for colorectal cancer) and made lifestyle changes, such as reading heart health materials and increasing physical activity, demonstrating the program's potential to improve heart health and access to preventive care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of Healthy Fit: A Community Health Worker Model to Address Hispanic Health Disparities. Brown, LD., Vasquez, D., Salinas, JJ., et al.[2021]

The Novartis Cardio Metabolic Program significantly improved blood pressure control among participants, increasing from 38% at baseline to 79% after 6 months, indicating effective management of hypertension.

Participants also showed improved control of low-density lipoprotein cholesterol, rising from 22% to 34%, and a significant decrease in body mass index, highlighting the program's positive impact on cardiovascular risk factors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A health outcome assessment of the Cardio Metabolic Mission Health Program at Novartis. Mauceri, E., Bienkowski, C., Hanson, KA., et al.[2019]

The My Health Matters! program successfully engaged 43% of employees in health risk assessments and identified metabolic syndrome risk factors in over half of those who attended clinical visits, leading to a significant 15% reduction in risk factors over six months.

The program was well-received, with 82% of participants recommending it to other employers, demonstrating its feasibility and value as a workplace intervention for managing metabolic health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Partnership in employee health. A workplace health program for British Columbia Public Service Agency (Canada). Tarride, JE., Harrington, K., Balfour, R., et al.[2017]

The 'Vida Sana/Healthy Life' program effectively improved health literacy among low-income, uninsured individuals, with nearly 90% of participants showing increased understanding of healthy lifestyles after completing the program.

At least 60% of participants in the program experienced reductions in key risk factors for metabolic syndrome, such as blood sugar, cholesterol, and body mass index, indicating the program's efficacy in promoting healthier outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vida Sana: a lifestyle intervention for uninsured, predominantly Spanish-speaking immigrants improves metabolic syndrome indicators. Buckley, J., Yekta, S., Joseph, V., et al.[2022]

In a study of 545 participants at risk for metabolic syndrome, those who attended a lifestyle intervention program more frequently (high attendance group) showed significant reductions in dyslipidemia risk for males and overweight risk for females after 27 months.

The high attendance group also experienced a notable decrease in the overall risk score for metabolic syndrome, highlighting the importance of consistent participation in health education programs for effective risk reduction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High attendance at a lifestyle intervention program is important to reduce risks related to metabolic syndrome in middle-aged Japanese. Fujii, H., Haruyama, Y., Muto, T., et al.[2022]

The Compañeros en Salud (CeS) program effectively reduced key health risks associated with metabolic syndrome among Mexican American women in rural Idaho, showing significant improvements in weight, BMI, and metabolic markers like A1c and glucose levels.

This community-based wellness initiative emphasizes behavior change in nutrition and physical activity, suggesting it could serve as a best practice model for obesity prevention in similar populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Family-based risk reduction of obesity and metabolic syndrome: an overview and outcomes of the Idaho Partnership for Hispanic Health. Schwartz, R., Powell, L., Keifer, M.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06725511

Wellness Program Outreach and Effectiveness This study will test whether an outreach approach that auto-enrolls eligible individuals-employees and their spouses/domestic partners-into the program, with ...

2. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06725511/wellness-program-outreach-and-effectiveness

Wellness Program Outreach and Effectiveness This study will test whether an outreach approach that auto-enrolls eligible individuals-employees and their spouses/domestic partners-into the ...

3. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/11/NCT06725511/SAP_000.pdf

A Randomized Controlled Trial Analysis Plan We will conduct a randomized controlled trial to evaluate the impact of an outreach campaign designed to increase engagement with Pack ...

4. trial.medpath.com trial.medpath.com/clinical-trial/590f984fb8f33bf5/nct06725511-wellness-program-outreach-effectiveness

Wellness Program Outreach and Effectiveness | MedPath This study will test whether an outreach approach that auto-enrolls eligible individuals-employees and their spouses/domestic partners-into the program, with ...

5. meddatax.com meddatax.com/clinical-trials/NCT06725511

Wellness Program Outreach and Effectiveness This trial will provide evidence on whether an opt-out framing in outreach campaigns can enhance the effectiveness of wellness programs, ...

6. questdiagnostics.com questdiagnostics.com/patients/blog/articles/uncovering-the-impact-of-metabolic-syndrome

Uncovering the impact of metabolic syndrome Are you dealing with metabolic syndrome? Discover its impact on the heart, liver, and kidneys, as well as diabetes, and learn how to reclaim ...