Adolescent Bariatrics: Controlled Longitudinal Study of Psychosocial Development

描述（由申请人提供）：共同研究者与NIDDK工作人员合作，最近创建了一个四中心手术研究联盟，即青少年减肥手术纵向评估或青少年实验室（U 01 DK 072493）。作为一项前瞻性、纵向减肥队列观察性研究，Teen-LABS的初步目的是反映成人手术研究联盟（减肥手术纵向评估）（LABS）的关键数据收集要素，以记录青少年减肥手术的安全性以及与成人结局相比的术后6、12和24个月的健康结局。青少年减肥手术发生在心理社会发展的重要时期，这是一个情感、人际关系、社会和职业/职业领域迅速变化的时期，在这个时期，良好的适应预示着在向成年期（18-20岁）过渡的过程中继续积极的适应。减肥手术有可能积极改变极端肥胖青少年的心理社会和由此产生的发展轨迹。根据目前的设计，Teen-LABS未考虑青少年患者的年龄显著性心理社会和发育范式，并且缺乏青少年非手术比较组-关键差距，这对于阐明该独特发育阶段手术的风险和受益至关重要。为了解决这些差距，这项对Teen-LABS的辅助研究将采用前瞻性、对照、纵向设计，并在相同的时间内随访两个平行的青少年队列：170名Teen-LABS参与者（年龄14-18岁）和236名从两个Teen-LABS研究中心招募的人口统计学匹配的非手术极度肥胖青少年。两个队列将在基线/术前和术后前2年内的不同时间点完成一系列测量。除了已经在Teen-LABS方案中评估的数据元素（BMI、抑郁症状、暴食、生活质量）外，本研究还将记录手术对年龄显著的青少年心理社会功能的其他领域的积极影响（例如，感知能力、同伴受害、社会支持、身体形象）以及可能导致心理社会功能个体差异的因素（父母/家庭功能受损、健康风险行为、高风险环境）。此外，辅助研究将在青少年实验室中增加一项至关重要的24个月结果指标--达到成年期（18-20岁）的年龄显著发展任务（即，学术成就，工作能力，社会/浪漫参与）。增加一个人口统计学匹配的非手术极端肥胖对照组将提供重要的信息，关于青少年极端肥胖的自然过程中的背景下，以评估减肥手术的长期心理社会和发展的健康的极端肥胖青少年的相对影响。因此，拟议研究的创新目标和研究设计将大大提高青少年实验室的科学贡献。

DESCRIPTION (provided by applicant): Co-Investigators, in cooperation with NIDDK staff, recently created a four-center surgical research consortium, the Teen-Longitudinal Assessment of Bariatric Surgery or Teen-LABS (U01 DK072493). Designed as a prospective, longitudinal bariatric cohort observational study, the initial aims of Teen-LABS are to mirror key data collection elements of the adult surgical research consortium (Longitudinal Assessment of Bariatric Surgery) (LABS) to document the safety of bariatric surgery in adolescence and the post-operative health outcomes at 6, 12- and 24-months as compared to adult outcomes. Adolescent bariatric surgery occurs at an important time in psychosocial development-a period of rapid change in emotional, interpersonal, social, and career/vocational domains in which good adaptation bodes well for continued positive adaptation in the transition to emerging adulthood (ages 18-20). Bariatric surgery has the potential to positively alter the psychosocial and resultant developmental trajectory of adolescents with extreme obesity. As currently designed, Teen-LABS does not consider the adolescent patient within age-salient psychosocial and developmental paradigms and lacks an adolescent non-operative comparative group-critical gaps important to elucidating the risks and benefits of surgery during this unique developmental stage. To address these gaps, this ancillary study to Teen-LABS will utilize a prospective, controlled, longitudinal design and follow two parallel cohorts of adolescents over the same course of time: 170 Teen-LABS participants (ages 14-18) and 236 demographically matched non-operative extremely obese adolescents recruited from two Teen-LABS sites. Both cohorts will complete a series of measures at baseline/pre-surgery and at various time-points within the first 2 years post surgery. In addition to data elements already assessed within the Teen-LABS protocol (BMI, depressive symptoms, binge eating, quality of life), the present study will document the positive impact of surgery on additional domains of age-salient adolescent psychosocial functioning (e.g., perceived competence, peer victimization, social support, body image) and factors that may account for individual variations in psychosocial functioning (impaired parent/family functioning, health risk behaviors, high risk contexts). In addition, the ancillary study will add a critically important 24-month outcome measure to Teen-LABS-the attainment of age-salient developmental tasks of emerging adulthood (ages 18-20) (i.e., academic attainment, work competence, social/romantic involvement). The addition of a demographically matched non-operative extremely obese comparison group will provide vital information regarding the natural course of adolescent extreme obesity-a context in which to evaluate the relative impact of bariatric surgery on the long-term psychosocial and developmental well being of extremely obese adolescents. Hence, the innovative aims and research design of the proposed study will significantly enhance the scientific contribution of the Teen-LABS.