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

描述（由申请人提供）：肥胖症在智力残疾（ID）人群中比在普通人群中更普遍。这一人群的减肥在青春期尤为重要，青春期是父母传授健康饮食和体育活动知识和技能的关键时期，以期待他们的孩子过渡到成年和独立生活。以家庭为基础的治疗在促进发育正常的儿童和青少年的体重减轻方面是有效的，但据我们所知，还没有关于ID儿童或青少年的随机对照试验（RCT）报告，迫切需要进行研究。该R 01提案旨在建立在我们最近完成的唐氏综合征青少年/年轻人RCT（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。本R 01提案的具体目标是：1）对我们的试点项目（FBBI）进行所需的更大规模的复制，48名15-22岁的ID青少年与父母一起参与该项目，随机接受FBBI或延迟治疗（DT）;和2）发展，实施和评估旨在通过长期生活方式维持策略维持体重减轻的后续维持干预（FBBI+MI）。FBBI完成后，受试者将随机接受为期6个月的FBBI-MI干预或无治疗期。这项研究的主要结果是青少年参与者体重状况的变化，报告为体重指数（BMI）。次要结果是在以下方面的变化：水果，蔬菜和高能量密度食物的消费;花费在中度到剧烈体力活动上的时间;屏幕时间;和自我效能。在基线、6个月（研究结束时） FBBI）、12个月（FBBI+MI结束）和18个月（无干预随访）。分配至DT组的受试者在最初6个月延迟后开始开始FBBI，在此期间，他们作为对照，因此接受额外的基线测量。通过直接观察或录音带审查20%的会议，包括干预者的营养教育，个人营养咨询和家长行为培训组成部分的执行情况进行评估的治疗保真度。这项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信息。

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.