A Family-Based Weight Loss Intervention for Youth with Intellectual Disability

描述(申请人提供)：智障人士(ID)的肥胖症比普通人群更为普遍。在这一群体中，减肥在青春期尤为重要，这是一个关键时期，父母可以在这一关键时期传授健康的饮食和体育活动知识和技能，以期他们的孩子过渡到成年并独立生活。以家庭为基础的治疗在促进典型发育中的儿童和青少年减肥方面一直是有效的，但据我们所知，还没有关于患有ID的儿童或青少年的随机对照试验(RCT)的报道，因此迫切需要研究。这份R01提案试图建立在我们最近完成的针对唐氏综合症青少年/年轻人的随机对照试验(N=21)的基础上，我们发现令人鼓舞的结果有利于我们所说的基于家庭的行为干预(FBBI)，而不是纯粹的教育方法。这份R01建议的具体目标是：1)对我们的试点计划(FBBI)进行必要的更大规模的复制，有48名15-22岁的ID青少年与父母一起参与该计划，随机接受FBBI或延迟治疗(DT)；以及2)开发、实施和评估旨在通过长期生活方式维持策略维持减肥的后续维持干预措施(FBBI+MI)。在FBBI完成后，参与者将被随机分为FBBI-MI干预组6个月或不治疗组。这项研究的主要结果是青少年参与者体重状况的变化，报告为身体质量指数(BMI)。次要结果是青少年的变化：水果、蔬菜和高能量密集型食物的摄入量；花在中等到剧烈体力活动上的时间；屏幕时间；以及自我效能。数据在基线时收集，6个月(年末 FBBI)、12个月(FBBI+MI结束)和18个月(无干预随访)。被分配到DT的参与者在最初的6个月延迟后开始FBBI，在此期间他们作为对照组，因此接受额外的基线测量。治疗忠诚度通过直接观察或20%的课程的录音带审查来评估，包括干预者实施营养教育、个人营养咨询和家长行为培训部分。本研究的结果将有助于青少年减肥的研究，并为更大规模的研究和临床干预提供参考。

DESCRIPTION (provided by applicant): Obesity is more prevalent in persons with intellectual disabilities (ID) than in the general population. Weight loss in this population is particularly important during adolescence, a critical period in which parents can impart healthful dietary and physical activity knowledge and skills in anticipation of their child's transition into adulthood ad independent living. Family-based treatments have been effective in promoting weight loss among typically developing children and adolescents, but to our knowledge no randomized controlled trials (RCTs) have been reported with children or adolescents with ID, and research is sorely needed. This R01 proposal seeks to build upon our recently completed RCT (N=21) with adolescents/young adults with Down syndrome in which we found encouraging results favoring what we refer to as family-based behavioral intervention (FBBI) over a purely educational approach. The specific aims of this R01 proposal are to: 1) conduct a needed larger replication of our pilot program (FBBI) with 48 adolescents with ID aged 15-22 years, participating in the program with a parent, randomized to FBBI or delayed treatment (DT); and 2) develop, implement and evaluate a follow-up maintenance intervention (FBBI+MI) designed to sustain weight loss through longer-term lifestyle maintenance strategies. After completion of the FBBI, participants will be randomized to either a FBBI-MI intervention for 6 months or a no treatment period. The primary outcome of this study is change in adolescent participants' weight status, reported as body mass index (BMI). Secondary outcomes are changes in adolescents': fruit, vegetable and high energy-dense food consumption; time spent in moderate to vigorous physical activity; screen time; and self-efficacy. Data are collected at baseline, 6 months (end of FBBI), 12 months (end of FBBI+MI) and 18 months (no-intervention follow-up). Participants assigned to DT begin FBBI after an initial 6-month delay, during which they serve as controls, and therefore receive an additional baseline measurement. Treatment fidelity is assessed by direct observation or audiotape review for 20% of sessions, covering the interventionists' implementation of nutrition education, individual nutrition counseling and parent behavioral training components. The results of this study will contribute to the research on weight reduction for adolescents and inform larger-scale research and clinical interventions.