TY - JOUR
T1 - Adaptation of a Mobile Interactive Obesity Treatment Approach for Early Severe Mental Illness
T2 - Protocol for a Mixed Methods Implementation and Pilot Randomized Controlled Trial
AU - Nicol, Ginger E.
AU - Jansen, Madeline O.
AU - Ricchio, Amanda R.
AU - Schweiger, Julia A.
AU - Keenoy, Katie E.
AU - Miller, J. Philip
AU - Morrato, Elaine H.
AU - Guo, Zhaohua
AU - Evanoff, Bradley A.
AU - Parks, Joseph J.
AU - Newcomer, John W.
N1 - Funding Information:
GEN has received grant support from the National Institutes of Health, the Health Resources and Services Administration, the Barnes Jewish Hospital Foundation, the McDonnell Center for Systems Neuroscience, LB Pharmaceuticals, Alkermes, Inc., and Usona Institute (drug only), and has served as a consultant for Alkermes, Inc., Novartis, Otsuka America, Inc., and Sunovion. BE has received funding from the National Institutes of Health and the Centers for Disease Control and Prevention. JJP has participated in advisory panels or consulted with Merck, Boehringer-Ingelheim, Lundbeck, Otsuka, and Janssen. JWN has received grant support from the National Institutes of Health and the Substance Abuse and Mental Health Services Administration; has served as a consultant for Alkermes, Inc., Intra-cellular Therapies, Inc., Sunovion and Merck; and served on a data safety monitoring board for Amgen. EHM has provided consulting services to Eli Lilly, Reata Pharmaceuticals, Syneos Health, and United Healthcare Services. MJ, AR, JAS, and KK have no disclosures.
Funding Information:
This work was supported by the National Institute of Mental Health grant MH118395, the Healthy Mind Lab and the Center for Brain Research in Mood Disorders in the Washington University Department of Psychiatry, the Washington University Center for Diabetes Translational Research funded by a grant from the National Institute of Diabetes and Digestive and Kidney Disorders, (P30DK092950), and the Washington University Institute for Public Health and the Mobile Health Research Core in the Institute of Clinical and Translational Sciences funded by grant UL1TR002345 from the National Center for Advancing Translational Sciences of the National Institutes of Health. The content is solely the responsibility of the authors and does not necessarily represent the official view of the National Institutes of Health.
Publisher Copyright:
© 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. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 09.06.2023. This is an open-access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on https://www.researchprotocols.org, as well as this copyright and license information must be included.
PY - 2023
Y1 - 2023
N2 - 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.
AB - 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.
KW - community mental health services
KW - implementation science
KW - mental disorders
KW - obesity
KW - primary prevention
UR - http://www.scopus.com/inward/record.url?scp=85162042539&partnerID=8YFLogxK
U2 - 10.2196/42114
DO - 10.2196/42114
M3 - Article
C2 - 37294604
AN - SCOPUS:85162042539
SN - 1929-0748
VL - 12
JO - JMIR Research Protocols
JF - JMIR Research Protocols
M1 - e42114
ER -