Engaging self-regulation targets to understand the mechanisms of behavior change and improve mood and weight outcomes

 描述（由申请人提供）：背景：肥胖影响36%的美国女性和男性，并增加糖尿病和心血管疾病的终生风险。同样，抑郁症影响着20%的美国女性和13%的男性，是全球残疾的主要原因。此外，这两种疾病具有双向正相关关系。存在治疗肥胖和抑郁症的行为干预措施;然而，潜在的生物学机制仍然未知。这种缺乏了解的情况严重阻碍了优化行为干预措施有效性的努力，并限制了其传播和实施，使其成为广泛的实践，以减少肥胖和抑郁症的不良后果，促进人口健康。人类神经科学和行为科学的快速发展以及两者的整合可以为填补这一空白提供独特的机会。目的：利用最近资助的一项为期2年的随机对照试验（“RAINBOW”target n=404; PI Dr. Jun Ma）在初级保健中首次对共病肥胖和抑郁症进行综合治疗，该治疗独特地结合了2种国家认可的行为干预，我们提出了一个2阶段项目，以确定、验证和改进一套测定自我调节目标的测定法;并利用这些目标来优化肥胖和抑郁症的行为治疗。具体目标：在UH 2阶段，我们将（1）进行二次数据分析，并举办研讨会和专题讨论会，以最终确定自我调节目标和检测方法的选择;（2）利用RAINBOW干预措施来参与确定的目标;以及（3）跨多个域验证目标参与（神经、生理、行为、心理）、设置（实验室、虚拟和自然）和时间点（0、4周、6、12和24个月）过渡性里程碑是（1）建立可靠和准确测量已识别靶标的检测方法;（2）证明自我调节目标响应RAINBOW综合治疗的延展性;以及（3）识别预测健康行为（医疗方案依从性、身体活动、饮食）和结果（体重、抑郁）的治疗响应的自我调节概况。在UH 3阶段，我们将进行一项初步随机对照试验，其中另外100名肥胖和抑郁的成年人将被随机分配到干预组或等待名单对照组，并在基线、4周和6个月时进行评估。干预受试者将接受RAINBOW干预的前4周，然后是干预组件的目标引导定制，以优化目标参与，并在前4周内根据其个人自我调节特征增强行为变化。我们将使用干预对象的见解，然后进一步完善为waitlis主题的剪裁策略。含义：这项研究将提供一个工具包，充分验证的自我调节目标的分析，重要的健康行为的改变，以及目标导向的个性化干预策略，在治疗肥胖和抑郁症的共病。影响：鉴于这些疾病和目标健康行为的广泛相关性，这项研究将成为治疗多种慢性疾病的原型，对人群健康具有深远的潜在影响。

 DESCRIPTION (provided by applicant): Background: Obesity affects 36% of US women and men and increases lifetime risk for diabetes and cardiovascular disease. Similarly, depression affects 20% of US women and 13% of men and is the leading cause of disability worldwide. Further, the 2 disorders have a bidirectional positive relationship. Proven behavioral interventions to treat obesity and depression exist; however, the underlying biological mechanisms remain unknown. This lack of understanding significantly hampers efforts to optimize the effectiveness of behavioral interventions and limits their dissemination and implementation into widespread practice to curtail the adverse consequences of obesity and depression and promote population health. Rapid advances in human neuroscience and behavioral science and integration of the two could provide unique opportunity to fill this gap. Objective: Leveraging a recently funded 2-year randomized controlled trial ("RAINBOW" target n=404; PI Dr. Jun Ma) of a first-ever integrated treatment for comorbid obesity and depression in primary care that uniquely combines 2 nationally recognized behavioral interventions, we propose a 2-phased project to identify, validate and refine a set of assays to measure self-regulation targets; and to engage these targets to optimize behavioral treatment of obesity and depression. Specific Aims: In the UH2 phase, we will (1) Conduct secondary data analysis and hold workshops and a symposium to finalize selection of self-regulation targets and assays for testing; (2) Leverage the RAINBOW intervention to engage identified targets; and (3) Verify target engagement across multiple domains (neural, physiological, behavioral, psychological), settings (laboratory, virtual, and naturalistic), and time points (0, 4 weeks, 6, 12 and 24 months) Transitional milestones are to (1) Establish assay(s) that reliably and accurately measure the identified targets; (2) Demonstrate malleability of the self-regulation target(s) in response to th RAINBOW integrated treatment; and (3) Identify self-regulation profile(s) that predict treatment response in health behaviors (medical regimen adherence, physical activity, diet) and outcomes (weight, depression). In the UH3 phase, we will conduct a pilot randomized controlled trial in which an additional 100 obese and depressed adults will be randomized to intervention or wait-list control and assessed at baseline, 4 weeks and 6 months. Intervention subjects will receive the first 4 weeks of the RAINBOW intervention, followed by target-guided tailoring of the intervention components in order to optimize target engagement and enhance behavioral change based on their individual self-regulation profile during the first 4 weeks. We will use the insights from intervention subjects to then further refine the tailoring strategies for the waitlis subjects. Implications: This research will provide a toolkit of well-validated assays of self-regulation targets important for health behavior change, as well as target- guided personalization of intervention strategies, in the treatment of comorbid obesity and depression. Impact: Given the widespread relevance of these disorders and the targeted health behaviors, this research will be a prototype for treating multiple chronic conditions with profound potential impacts on population health.