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

BACKGROUND Obesity is common in individuals with severe mental illness (SMI), contributing to 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 Objective: Here, we describe a type 1 hybrid study design for adapting and pilot testing an existing mobile health (mHealth) intervention for obesity prevention in individuals with early SMI (eSMI) and Class I or early-stage obesity, defined as a body mass index of 30-35. METHODS An existing, evidence-based interactive obesity treatment approach (iOTA) employing low-cost, semi-automated short message system (SMS) texting was selected for adaptation. Community mental health clinics (CMHCs) and Clubhouse settings in Eastern Missouri and South Florida were identified to participate. Aim 1: Using the Enhanced Framework for Reporting Adaptations and Modifications to Evidence-based interventions (FRAME), contextual aspects of the clinical and digital treatment environments are identified for adaptation, considering five main stakeholder groups (clinical administrators, prescribing clinicians, case managers, nurses, and patients). Following a 2-week trial of un-adapted SMS messaging, Innovation Corps (I-Corps) methods are used to discover needed intervention adaptations by stakeholder group and clinical setting. Aim 2: 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 CMHC and Clubhouse settings will be trained in intervention delivery. Aim 3: 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 adapted iOTA treatment or to an attentional control condition, followed by a 3-month extension phase of text messages only. Change in weight, body mass index (BMI) and behavioral outcomes, as well as implementation challenges, will be evaluated at 6 and 9 months. RESULTS IRB approval for Aims 1 and 2 was granted on 8/12/19, with 72 focus group participants enrolled; IRB approval for Aim 3 was granted on 5/6/20. 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 an mHealth 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. CLINICALTRIAL NCT03980743 (https://clinicaltrials.gov/ct2/show/NCT03980743)