# Adaptation of an Evidence-based Interactive Obesity Treatment Approach (iOTA) for Obesity Prevention in Early Serious Mental Illness: iOTA-eSMI

> **NIH NIH R34** · WASHINGTON UNIVERSITY · 2020 · $207,531

## Abstract

Project Summary/Abstract
This revised R34 is responsive to RFA-MH-18-706, to the ongoing NIMH interest in Digital Health, and to the
prior review. Most obesity and related complications in serious mental illness (SMI) occur in the context of
chronic psychiatric illness. Behavioral interventions to reverse obesity in chronic SMI face challenges with long-
term effectiveness, implementation and sustainability. Pharmacotherapies are limited to off-label treatments
with modest effectiveness and/or serious adverse event risks. This application focuses on prevention of
chronic obesity by adapting and pilot testing a prevention-focused, interactive obesity treatment approach
(iOTA) for use in persons with early-phase SMI (eSMI) experiencing initial weight gain, overweight or early
class I obesity. The intervention will be adapted from the most studied, effective iOTA (e.g., weight loss at 24
months), derived from the Diabetes Prevention Program. Planned adaptations address eSMI, prevention
(focus on weight gain attenuation), and RDoC-relevant target mechanism engagement. The immediate parent
iOTA for this application uses health coaches who extend their sustainable reach with scalable, inexpensive,
semi-automated SMS messaging, a highly-utilized technology among low-income populations, to increase
intervention engagement, effectiveness and cost-effectiveness. Using a formal evaluation process and specific
implementation science framework, planned adaptations for this application address eSMI, prevention, and
RDoC-relevant target mechanism engagement, hypothesizing increased health-related awareness, insight and
self-efficacy for food intake and activity. Our overarching aim is to adapt and pilot a scalable, sustainable,
prevention-focused iOTA for use in the broad community mental health center (CMHC) population of
at-risk persons with eSMI, planning for future effectiveness testing in a fully-powered RCT and
eventual large scale implementation.
Specific Aim 1: Evaluate barriers and facilitators for intervention engagement, effectiveness and
implementation, and identify needed adaptations of the prior iOTA for use in obesity attenuation in eSMI.
Specific Aim 2: Adapt the prior iOTA for use in obesity attenuation in eSMI, aiming to maximize acceptability,
engagement, sustainable reach and target engagement for eSMI.
Specific Aim 3: Conduct a randomized pilot and feasibility study of iOTA-eSMI in a diverse sample of adults
aged 18-45 with eSMI and initial weight gain, overweight or early class I obesity, comparing iOTA-eSMI to a
health education control condition. The goal of this study is to measure feasibility, acceptability, tolerability, and
target engagement, exploring effects on change in body weight from baseline with iOTA-eSMI compared to
control. Secondary analyses will assess iOTA effects on RDoC domains relevant to needed psychophysical
skills and self-efficacy, exploring the relationship between weight change and target engagement.
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## Key facts

- **NIH application ID:** 9993549
- **Project number:** 5R34MH118395-02
- **Recipient organization:** WASHINGTON UNIVERSITY
- **Principal Investigator:** JOHN W. NEWCOMER
- **Activity code:** R34 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $207,531
- **Award type:** 5
- **Project period:** 2019-08-15 → 2022-05-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9993549

## Citation

> US National Institutes of Health, RePORTER application 9993549, Adaptation of an Evidence-based Interactive Obesity Treatment Approach (iOTA) for Obesity Prevention in Early Serious Mental Illness: iOTA-eSMI (5R34MH118395-02). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/9993549. Licensed CC0.

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