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Enrollment Strategies for Metabolic Syndrome
N/A
Recruiting
Led By Joseph Doyle, PhD
Research Sponsored by Massachusetts Institute of Technology
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Must not have
Anyone under the age of 21
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
No Placebo-Only Group
Summary
This trial will test if automatically enrolling eligible individuals into a wellness program can increase participation and improve health outcomes compared to the standard invitation-based approach.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since this trial involves participation in a wellness program rather than medication or medical procedures, traditional side effects aren't expected. However, there may be indirect effects related to lifestyle changes such as stress from behavior modification or physical discomfort from new exercise routines.
Eligibility Criteria
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am under 21 years old.
Select...
I have a history of an eating disorder, body dysmorphic disorder, major depression, PTSD, or severe anxiety.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Probability of Engagement initiation
Secondary study objectives
Annual Risk Assessment Measures: HbA1c
Annual Risk Assessment Measures: Weight
Probability of Engagement level
+1 moreOther study objectives
Mean number of ED visits
Mean number of Inpatient visits
Mean number of outpatient visits
+4 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
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 Location
Who is running the clinical trial?
University of Illinois at Urbana-ChampaignOTHER
199 Previous Clinical Trials
38,465 Total Patients Enrolled
4 Trials studying Metabolic Syndrome
300 Patients Enrolled for Metabolic Syndrome
Quest Diagnostics-Nichols InsituteIndustry Sponsor
13 Previous Clinical Trials
24,491 Total Patients Enrolled
Massachusetts Institute of TechnologyLead Sponsor
101 Previous Clinical Trials
12,820,025 Total Patients Enrolled
1 Trials studying Metabolic Syndrome
16 Patients Enrolled for Metabolic Syndrome
Joseph Doyle, PhDPrincipal InvestigatorMIT Sloan School of Management
3 Previous Clinical Trials
5,754 Total Patients Enrolled