Nicol Ginger E, Jansen Madeline O, Ricchio Amanda R, Schweiger Julia A, Keenoy Katie E, Miller J Philip, Morrato Elaine H, Guo Zhaohua, Evanoff Bradley A, Parks Joseph J, Newcomer John W
Department of Psychiatry, Washington University School of Medicine, Washington University in St. Louis, Saint Louis, MO, United States.
Division of Child & Adolescent Psychiatry, Department of Psychiatry, University of California, Los Angeles, Los Angeles, CA, United States.
JMIR Res Protoc. 2023 Jun 9;12:e42114. doi: 10.2196/42114.
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.
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.
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.
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.
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.
ClinicalTrials.gov NCT03980743; https://clinicaltrials.gov/ct2/show/NCT03980743.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/42114.
肥胖在重度精神疾病（SMI）患者中很常见，与普通人群相比，这会显著缩短寿命。现有的减肥治疗方法在该人群中的疗效减弱，凸显了预防和早期干预的重要性。
在此，我们描述了一种1型混合研究设计，用于调整并初步测试一种现有的移动健康干预措施，以预防早期SMI且体重指数（BMI）为30 - 35的I级或早期肥胖个体肥胖。
选择一种现有的、基于证据的交互式肥胖治疗方法，该方法使用低成本的半自动短信文本。确定密苏里州东部和南佛罗里达州的社区心理健康诊所和俱乐部会所参与。本研究有以下3个目标。首先，使用《基于证据的干预措施改编与修改报告增强框架》，考虑5个主要利益相关者群体（临床管理人员、开处方的临床医生、病例管理人员、护士和患者），确定临床和数字治疗环境的背景因素以进行调整。在对未调整的短信文本进行为期2周的试验后，采用创新团队方法按利益相关者群体和临床环境发现所需的干预调整。其次，将根据目标1中确定的主题对数字功能和干预内容进行调整，随后与关键利益相关者进行快速可用性测试。将开发一个迭代治疗调整过程，以便在目标3实施初步研究期间进行计划外修改。在合作社区心理健康诊所和俱乐部会所工作的人员将接受干预实施培训。第三，在一项随机初步和可行性试验中，患有SMI诊断且治疗时间为5年或更短的成年人将按2:1随机分配，接受为期6个月的调整后的交互式肥胖治疗方法或注意力控制条件，随后是仅为期3个月的短信文本扩展阶段。将在6个月和9个月时评估体重、BMI和行为结果的变化以及实施挑战。
2018年8月12日获得了目标1和2的机构审查委员会批准，有72名焦点小组参与者登记；2020年5月6日获得了目标3的机构审查委员会批准。迄今为止，已有52名参与者登记参加该研究方案。
在这种1型混合研究设计中，我们应用基于证据的治疗调整框架，在实际治疗环境中计划、调整并进行移动健康干预的可行性测试。本研究位于社区心理健康治疗与身体健康促进的交叉点，旨在推进使用简单技术预防早期精神疾病个体的肥胖。
ClinicalTrials.gov NCT03980743；https://clinicaltrials.gov/ct2/show/NCT03980743。
国际注册报告识别码（IRRID）：DERR1-10.2196/42114。
