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This study protocol outlines a hybrid trial to test a peer-led healthy lifestyle program for individuals with serious mental illness (SMI) and obesity. It integrates effectiveness testing with implementation science to improve physical health outcomes.

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Area of Science:

  • Implementation Science
  • Health Disparities Research
  • Clinical Trial Design

Background:

  • Individuals with serious mental illness (SMI) have double the risk of obesity.
  • Racial and ethnic minority status exacerbate health risks in this population.
  • Supportive housing agencies serve diverse clients with SMI who are overweight or obese.

Purpose of the Study:

  • To describe the protocol of a Hybrid Trial Type 1 design.
  • To test the effectiveness of a peer-led healthy lifestyle intervention.
  • To examine the implementation of this intervention in supportive housing agencies.

Main Methods:

  • Combines a randomized effectiveness trial with a mixed-methods implementation study.
  • Peer-led healthy lifestyle intervention (based on Group Lifestyle Balanced Program) delivered over 12 months by trained peer specialists.
  • Mixed-methods implementation study examines multi-level factors using interviews, focus groups, and surveys with agency stakeholders.

Main Results:

  • Effectiveness trial assesses health impacts of intervention versus usual care.
  • Repeated assessments at baseline, 6, 12, and 18 months post-randomization.
  • Implementation study data collected before, during, and after the effectiveness trial.

Conclusions:

  • The hybrid design integrates effectiveness and implementation science for SMI physical health research.
  • This approach can serve as a model for integrating implementation science and health disparities research.
  • Rigorously testing effectiveness and implementation is crucial for large-scale delivery of interventions to improve physical health in racial/ethnic minorities with SMI.