Interactive Obesity Treatment Approach (iOTA) for Obesity Prevention in Serious Mental Illness
Condition: Obesity; Mentally Ill Persons
MeSH terms: Obesity; Mental Disorders
Study type: Interventional

Summary: 
      The proposed project aims to pilot and adapt a scalable and sustainable interactive obesity
      treatment approach (iOTA) program for adults with serious mental illness (SMI). The project
      consists of 2 arms: the iOTA SMI arm and the Health Education Control Group arm. The
      investigators hypothesize that participants in the iOTA intervention group will show
      favorable change in BMI compared to participants in the Health Education Control group, and
      participants in the iOTA intervention group will show favorable change in self efficacy with
      respect to healthy eating and activity compared to those in the Health Education Control
      group.
    

Detailed description: 
      Obesity is highly prevalent among chronically-treated individuals with severe mental illness
      (SMI), exceeding general population rates and contributing to type 2 diabetes, cardiovascular
      disease (CVD) and premature mortality. Behavioral interventions to reverse obesity in chronic
      SMI have shown limited effectiveness. There are currently no FDA-approved pharmacotherapies
      for obesity in SMI, and off-label pharmacotherapies used for weight loss are associated with
      limited effectiveness or serious adverse event risks. Prior obesity interventions for SMI
      have often been designed for delivery by existing community mental health center (CMHC)
      caseworkers/staff. However, mental health workers commonly perceive themselves as overworked
      and/or career-specialized for psychological rather than medical care, creating barriers to
      sustainable provider engagement.

      Using a design-for-dissemination approach, initial development of the intervention under
      study incorporated trained health coaches using scalable, inexpensive technology to increase
      intervention engagement, effectiveness, sustainable reach and cost-effectiveness. Derived
      from the effective lifestyle intervention used in the Diabetes Prevention Program, the
      initial parent Interactive Obesity Treatment Approach (iOTA) intervention targets diet,
      activity and medication adherence, incorporating electronic (e.g., web-based) and
      interpersonal health coach support. That parent iOTA produces weight loss at 24 months in
      low-income, racially diverse, community health center populations with obesity, and became a
      platform for further adaptations of iOTA interventions for other populations and
      environments, targeting low-income populations with limited web and computer access. Using a
      formal evaluation process and implementation science framework, the parent iOTA intervention
      was subsequently adapted to low-income workplace environments, (the Working for You or WfY
      study, RO1 DK103760; PI: Evanoff) amplifying face-to-face health coach and peer interactions
      with interactive, semi-automated SMS text messaging, a highly utilized technology among
      low-income populations.

      The investigators further adapted the WfY iOTA for use in adults with chronic SMI using
      Innovation Corps (I-Corps) methods. Created by the National Science Foundation (NSF) and
      supported by NIH (PA-18-314), I-Corps uses the Lean Launchpad approach developed by serial
      entrepreneurs at Stanford for translating academic innovation into practice. The emphasis is
      on immediate and iterative elicitation of stakeholder feedback via focus groups or short
      interviews. Using stakeholder input, investigators revise assumptions and hypotheses, testing
      redesigned offerings and making adjustments to ideas that are not working. In conducting our
      interviews, we identified "customer" specific (e.g. client, clinician and administrator)
      barriers to implementation of an un-adapted iOTA in mental health treatment centers. Themes
      that consistently emerged were concern about limited human resources and added work burden
      not directly related to the mental health of clients, while clients expressed a desire for
      more in-person and telephonic coaching time, in addition to text messaging.

      Now, the investigators propose to use an overarching treatment adaptation framework18 to
      further refine our treatment to be more readily implementable for individuals with chronic
      SMI treated in the CMHC setting. Reproducible adaptation of effective interventions to new
      target populations and settings requires a formal evaluation process and an implementation
      science framework. Our overarching aim for this application is to pilot and iteratively adapt
      a scalable and sustainable iOTA for adults with SMI, planning for future effectiveness
      testing in a well-powered randomized controlled trial (RCT), and eventual large scale
      dissemination and implementation.

      Aim 1: Conduct a randomized pilot and feasibility study of iOTA-SMI in a diverse sample of
      adults with chronic SMI, comparing iOTA-SMI to a health education control condition. iOTA-SMI
      will be piloted in a representative sample of 40 adults ages 18-60 with SMI, randomizing
      participants 2:1 to 16 weeks of iOTA-SMI versus monthly health education. We hypothesize
      favorable differences in BMI for iOTA-SMI compared to control. Secondary analyses will assess
      iOTA effects on health self-efficacy, exploring the relationship between effects on Body Mass
      Index (BMI) and the target mechanism.

      Aim 2: Evaluate feasibility and acceptability of iOTA implementation, making iterative
      adaptations based on data collected during the pilot. Feasibility, engagement and
      implementation challenges will be characterized, measured by i) enrollment and retention, ii)
      obesity intervention acceptability, iii) text response rates, iv) visit adherence v) client
      expectations, vi) fidelity and vii) CMHC staff-rated acceptability, appropriateness and
      burden.
    

Intervention name(s): iOTA SMI; Health Education Control
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants randomized to the iOTA SMI arm will undergo an assessment of individual behavior risks, will participate in collaborative goal-setting with a health coach, and will use an interactive text system that will provide ongoing support and self-monitoring of behavior change goals.; Participants randomized to the Health Education Control arm will receive monthly counseling on energy balance, physical activity and nutrition.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Antipsychotics