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RCT·psychiatry, nutrition, public health, internal medicine, clinical trial·PMC10337417

Adaptation of a Mobile Interactive Obesity Treatment Approach for Early Severe Mental Illness: Protocol for a Mixed Methods Implementation and Pilot Randomized Controlled Trial

JMIR Research Protocols · 11 authors, 8 centres

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TL;DR

This protocol describes a pilot randomized controlled trial to adapt and test a mobile health (mHealth) obesity prevention intervention for adults with early severe mental illness. The study uses a mixed-methods implementation design to adapt an SMS-based program and evaluate its feasibility and preliminary effects on weight change.

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The study adapts an evidence-based, SMS-based obesity treatment intervention for individuals with early severe mental illness (SMI) and obesity. The adaptation process uses qualitative methods, including focus groups and usability testing, to tailor the intervention for community mental health clinic settings. The primary outcome is change in weight at 24 weeks; secondary outcomes include BMI and behavioral measures. Implementation outcomes like engagement and acceptability will also be assessed. This study aims to advance the use of simple technology for obesity prevention in a high-risk population and inform future, larger-scale trials.

STUDY TYPE

RCT

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psychiatry

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AI pipeline

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ORIGINAL PAPER

PMC10337417

Adaptation of a Mobile Interactive Obesity Treatment Approach for Early Severe Mental Illness: Protocol for a Mixed Methods Implementation and Pilot Randomized Controlled Trial

JMIR Research Protocols

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ABSTRACT

Background Obesity is common in individuals with severe mental illness (SMI), contributing to a significantly shortened lifespan when compared to the general population. Available weight loss treatments have attenuated efficacy in this population, underscoring the importance of prevention and early intervention. Objective Here, we describe a type 1 hybrid study design for adapting and pilot-testing an existing mobile health intervention for obesity prevention in individuals with early SMI and Class I or early-stage obesity, defined as a BMI of 30-35. Methods An existing, evidence-based interactive obesity treatment approach using low-cost, semiautomated SMS text messaging was selected for adaptation. Community mental health clinics and Clubhouse settings in Eastern Missouri and South Florida were identified to participate. This study has the following 3 aims. First, using the Enhanced Framework for Reporting Adaptations and Modifications to Evidence-based interventions, contextual aspects of the clinical and digital treatment environments are identified for adaptation, considering 5 main stakeholder groups (clinical administrators, prescribing clinicians, case managers, nurses, and patients). Following a 2-week trial of unadapted SMS text messaging, Innovation Corps methods are used to discover needed intervention adaptations by stakeholder group and clinical setting. Second, adaptations to digital functionality and intervention content will be made based on themes identified in aim 1, followed by rapid usability testing with key stakeholders. A process for iterative treatment adaptation will be developed for making unplanned modifications during the aim 3 implementation pilot study. Individuals working in partner community mental health clinics and Clubhouse settings will be trained in intervention delivery. Third, in a randomized pilot and feasibility trial, adults with 5 years or less of treatment for an SMI diagnosis will be randomized 2:1 to 6 months of an adapted interactive obesity treatment approach or to an attentional control condition, followed by a 3-month extension phase of SMS text messages only. Changes in weight, BMI, and behavioral outcomes, as well as implementation challenges, will be evaluated at 6 and 9 months. Results Institutional review board approval for aims 1 and 2 was granted on August 12, 2018, with 72 focus group participants enrolled; institutional review board approval for aim 3 was granted on May 6, 2020. To date, 52 participants have been enrolled in the study protocol. Conclusions In this type 1 hybrid study design, we apply an evidence-based treatment adaptation framework to plan, adapt, and feasibility test a mobile health intervention in real-world treatment settings. Resting at the intersection of community mental health treatment and physical health promotion, this study aims to advance the use of simple technology for obesity prevention in individuals with early-stage mental illness. Trial Registration ClinicalTrials.gov NCT03980743 ; https://clinicaltrials.gov/ct2/show/ NCT03980743 International Registered Report Identifier (IRRID) DERR1-10.2196/42114

CITATION EXPORT

Ginger E Nicol, Madeline O Jansen, Amanda R Ricchio et al.. Adaptation of a Mobile Interactive Obesity Treatment Approach for Early Severe Mental Illness: Protocol for a Mixed Methods Implementation and Pilot Randomized Controlled Trial. JMIR Research Protocols. (2023). https://doi.org/10.2196/42114

AUTHORS

11 · 8 CENTRES

Ginger E Nicol, Madeline O Jansen, Amanda R Ricchio, Julia A Schweiger, Katie E Keenoy, J Philip Miller, Elaine H Morrato, Zhaohua Guo, Bradley A Evanoff, Joseph J Parks, John W Newcomer

1 Department of Psychiatry Washington University School of Medicine Washington University in St. Louis Saint Louis, MO United States
2 Division of Child & Adolescent Psychiatry Department of Psychiatry University of California, Los Angeles Los Angeles, CA United States
3 Trial-CARE Division Center for Clinical Studies Washington University School of Medicine St. Louis, MO United States
4 Division of Biostatistics Washington University School of Medicine Washington University in St. Louis St. Louis, MO United States
5 Parkinson School of Health Sciences and Public Health Loyola University of Chicago Chicago, IL United States
6 Division of General Medical Sciences Department of Internal Medicine Washington University School of Medicine St. Louis, MO United States
7 National Council for Mental Wellbeing Washington DC, DC United States
8 Thriving Mind South Florida Miami, FL United States

EDITOR / REVIEWER

Amaryllis Mavragani, Gerald Jerome, Nicos Maglaveras