Enhanced Lifestyles for Metabolic Syndrome
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Metabolic Syndrome
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Single (Outcomes Assessor)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
The purpose of this trial is to determine the efficacy and cost-effectiveness of the Group-Based and Self-Directed ELM lifestyle programs when offered on a national level. A multi-site randomized trial will be conducted on 600 patients with the metabolic syndrome (MetS) by five national sites, each ...
The purpose of this trial is to determine the efficacy and cost-effectiveness of the Group-Based and Self-Directed ELM lifestyle programs when offered on a national level. A multi-site randomized trial will be conducted on 600 patients with the metabolic syndrome (MetS) by five national sites, each of which will randomize 120 patients to the Group-Based or Self-Directed programs. The Group-Based program targets healthy eating, physical activity, and stress reduction and is based upon neuroscience studies showing that mindful habits provide resilience against the power of emotions to subvert intention, and social science studies showing that sustainability is enhanced by support from a health network. The Self-Directed program represents enhanced usual care based upon what is currently offered in medicine and wearable technology for treatment of adults with MetS and its components. The primary outcome is remission of MetS at 2 years. Secondary outcomes include cost-effectiveness, vegetable intake, physical activity, and mindful awareness.
Tracking Information
- NCT #
- NCT04036006
- Collaborators
- University of Colorado, Denver
- Geisinger Clinic
- Rochester Institute of Technology
- University of Missouri, Kansas City
- Investigators
- Study Chair: Lynda Powell, PhD Rush University Medical Center Study Director: Sumihiro Suzuki, PhD Rush University Medical Center