Enrollment Strategies for Metabolic Syndrome
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Massachusetts Institute of Technology
Disqualifiers: Anorexia, Bulimia, Binge-eating, others
No Placebo Group
Approved in 1 Jurisdiction
Trial Summary
What is the purpose of 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.
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 data supports the effectiveness of the treatment Wellness Program Outreach, Pack Health, Quest Diagnostics Wellness Program for metabolic syndrome?
Research shows that lifestyle programs similar to the Wellness Program Outreach can improve health indicators related to metabolic syndrome. For example, the Vida Sana program helped participants lower risk factors like blood sugar and cholesterol, and the Compañeros en Salud program led to significant reductions in weight and blood pressure.
12345Is the treatment generally safe for humans?
The wellness programs mentioned, such as Compañeros en Salud and Vida Sana, focus on improving lifestyle habits like nutrition and physical activity, which are generally safe and have shown positive health outcomes without reported safety concerns.
24678How does this treatment for metabolic syndrome differ from other treatments?
This treatment is unique because it focuses on community-based programs that involve family and peer support to encourage lifestyle changes, such as improved nutrition and physical activity, rather than relying solely on medication. These programs, like Compañeros en Salud and Vida Sana, have shown significant improvements in health outcomes by using culturally appropriate education and social engagement to reduce risk factors associated with metabolic syndrome.
124910Eligibility Criteria
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)
I am over 18 and eligible for the Pack Health program.
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.
Trial Timeline
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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: Opt-out OutreachExperimental Treatment1 Intervention
Outreach notifies those eligible that they are enrolled in the program and invited to begin their first session.
Group II: Opt-in OutreachActive Control1 Intervention
Outreach notifies those eligible that they are invited to join the program, as usual practice.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Quest DiagnosticsSecaucus, NJ
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Who Is Running the Clinical Trial?
Massachusetts Institute of TechnologyLead Sponsor
University of Illinois at Urbana-ChampaignCollaborator
Quest Diagnostics-Nichols InsituteIndustry Sponsor
References
Evaluation of a Voluntary Worksite Weight Loss Program on Metabolic Syndrome. [2017]Health care costs increase with the presence of metabolic syndrome and present a significant burden to companies throughout the world. Identifying effective behavioral programs within the workplace can reduce health care costs. We examined the effect of a voluntary worksite program on weight loss and metabolic syndrome.
Family-based risk reduction of obesity and metabolic syndrome: an overview and outcomes of the Idaho Partnership for Hispanic Health. [2021]Mexican American women have the highest incidence of metabolic syndrome among all U.S. demographic groups. This paper details an innovative approach to reducing the risks for metabolic syndrome among Hispanic families in rural Idaho. Compañeros en Salud (CeS) is a promotora-led wellness program and community-based participatory research project from the Idaho Partnership for Hispanic Health. As behavior change is the first line of prevention and treatment of obesity and metabolic syndrome, the program aimed to improve nutrition and physical activity behaviors as well as increase community support and infrastructure for healthy living. CeS has demonstrated substantial improvement in health outcomes, with statistically significant reductions in weight, BMI, metabolic syndrome risk, A1c, glucose, blood pressure, and cholesterol, from pre-intervention to post-intervention and/or pre-intervention to one-year follow-up. These outcomes suggest the CeS model as a promising best practice for effecting individual and family-level physiologic and behavioral outcomes for obesity prevention.
Temporal Changes of Metabolic Indicators and Quality of Life by a Two-Day Patient Education Program for Metabolic Syndrome Patients. [2022]Metabolic syndrome (MetS) is a disease with a high prevalence that threatens the health of modern people. Patient education is essential to control MetS. This prospective study aimed to evaluate 6-month changes in health indicators following a two-day education program for patients with MetS aged 45 or older. Education about MetS, lifestyle modification, nutrition, and physical activity was provided. At 3 and 6 months after the program, participants visited for follow-up. Twenty-two patients completed the 6-month study. Waist circumference was reduced, and life quality and depression index improved in 3 and 6 months compared to pre-education. Blood pressure decreased, and anxiety index improved at three months. Nutritional knowledge was well maintained for 3 and 6 months. High-density lipoprotein-cholesterol levels increased at six months. Three out of twenty-two patients did not satisfy MetS criteria at the end of the study due to improved indicators. A two-day multidisciplinary education program positively affected health indicators in MetS patients. Participation in the program also help with life satisfaction and positive emotional condition. However, some indicators improved in 3 months, but the effect disappeared 6 months after the program.
Vida Sana: a lifestyle intervention for uninsured, predominantly Spanish-speaking immigrants improves metabolic syndrome indicators. [2022]Metabolic syndrome is an increasingly common condition that can contribute to the development of type 2 diabetes and cardiovascular disease. 35 % of adults living in the United States meet the criteria for having metabolic syndrome, with that number being even higher in populations with health disparities. We describe a 'healthy lifestyles' program implemented at a free clinic serving a predominantly Hispanic cohort of low-income, uninsured individuals living in Providence, Rhode Island. The "Vida Sana/Healthy Life" (Vida Sana) program uses low literacy, language-appropriate materials and trained peers to educate participants about healthy lifestyles in a setting that also provided opportunities for social engagement. 192 of 126 (65.6 %) participants in Vida Sana completed 6 out of 8 sessions of the Vida Sana program over a 12-month period. At the completion of the program, nearly 90 % of Vida Sana participants showed an increase in their health literacy, and at least 60 % of participants decreased each of the risk factors (blood sugar, cholesterol, body mass index or waist circumference) associated with metabolic syndrome.
The metabolic fitness program: lifestyle modification for the metabolic syndrome using the resources of cardiac rehabilitation. [2022]To describe and assess the effectiveness of a lifestyle intervention program (Met Fit) designed to treat the metabolic syndrome (MetSyn) in a cardiac rehabilitation setting.
A health outcome assessment of the Cardio Metabolic Mission Health Program at Novartis. [2019]To assess the impact of the Novartis Cardio Metabolic Program--an education, awareness, and health management initiative--on hypertension, hyperlipidemia, diabetes mellitus, and obesity within the Novartis employee population.
High attendance at a lifestyle intervention program is important to reduce risks related to metabolic syndrome in middle-aged Japanese. [2022]Evaluating attendance at health education programs is important to obtain a more comprehensive evaluation of the program impact. This study investigated whether attendance at a lifestyle intervention program in a community setting would reduce risks related to metabolic syndrome. Of 545 subjects with risks related to metabolic syndrome, i.e. overweight, hypertension, dyslipidemia or diabetes, participated in this non-randomized control study, 389 subjects aged 40-71 years completed the surveys at baseline and 27 months. Intervention group (39 males and 168 females) was provided 3 individual counseling plus 28 group sessions conducted monthly on average, whereas control group (64 males and 118 females) received only 7 health information newsletters by mail. Intervention group was subcategorized into two groups according to the median attendance (87.1%): 106 subjects with high attendance (93.8 +/- 4.7%) and 101 subjects with low attendance (68.6 +/- 16.0%). Logistic regression analyses adjusted for age and baseline value showed that among males, the proportion with dyslipidemia risk was lower only in high attendance group compared with that in control group at 27 months [Odds ratio (OR): 0.11 (95%CI 0.02 - 0.51)] and among females, the proportion of overweight was lower only in high attendance group [OR: 0.24 (95%CI 0.07 - 0.81)]. In females, the mean total risk score calculated by adding the number of the 4 risks present decreased only in high attendance group (p
Partnership in employee health. A workplace health program for British Columbia Public Service Agency (Canada). [2017]To evaluate the My Health Matters! (MHM) program, a multifaceted workplace intervention relying on education and awareness, early detection and disease management with a focus on risk factors for metabolic syndrome.
Evaluation of Healthy Fit: A Community Health Worker Model to Address Hispanic Health Disparities. [2021]Hispanics in the United States have disproportionately high rates of obesity, hypertension, and diabetes and poorer access to preventive health services. Healthy Fit uses community health workers to extend public health department infrastructure and address Hispanic health disparities related to cardiovascular disease and access to preventive health services. We evaluated the effectiveness of Healthy Fit in 1) reaching Hispanic Americans facing health disparities, and 2) helping participants access preventive health services and make behavior changes to improve heart health.
Insurance coverage and incentives for weight loss among adults with metabolic syndrome. [2017]To describe how insured adults with metabolic syndrome respond to various options for insurance coverage and financial incentives for weight management.