Interactive Obesity Treatment Approach (iOTA) for Obesity Prevention in Serious Mental Illness

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.

Inclusion Criteria:

- aged 18-60 years

- BMI ≥ 28

- have a diagnosis of a severe and persistent mental illness

- psychiatric symptoms present for at least 6 months prior to screening

- at least 6 months of lifetime antipsychotic exposure prior to screening

- not taking weight loss medications or participating in another behavioral weight loss
intervention

- enrolled in case management services

- able to provide written informed consent

Exclusion Criteria:

- acute suicidality at time of screening

- active substance use disorder diagnosis

- unable or unwilling to provide written informed consent