Brown Kristal Lyn, LaRose Jessica Gokee, Raynor Hollie A, Gorin Amy A, Thornton Laura M, Farthing Sarah, Tatum Kristina, Bean Melanie K
Department of Health Behavior and Policy, School of Population Health, Virginia Commonwealth University, Box 980430, Richmond, VA, 23298, United States.
Department of Medicine, Johns Hopkins University, School of Medicine, Division of General Internal Medicine, 2024 E Monument St, Baltimore, MD, 21205, United States.
Contemp Clin Trials Commun. 2024 Feb 15;38:101276. doi: 10.1016/j.conctc.2024.101276. eCollection 2024 Apr.
Understanding the effects of family-based lifestyle intervention beyond the treated adolescent is important, given that obesity is a familial disease and there are likely bidirectional relations between an adolescent's treatment success and broader household changes. However, it is unknown if recommended household-wide changes are adopted or if untreated family members experience weight-related benefits.
TEENS + REACH leverages our ongoing randomized clinical trial of TEENS+, a family-based lifestyle intervention for adolescents with obesity, to determine: 1) if household-wide changes to the shared home environment are implemented, 2) if ripple effects to untreated family members are observed, and 3) whether these changes are predictive of adolescents' weight management success. TEENS + REACH will expand trial assessments to include comprehensive assessments of the shared home feeding, weight, and physical activity environment of the target adolescents. Specifically, we will enroll untreated children (8-17yrs) and caregivers living in the same household as the target parent/adolescent dyad (N = 60 families). At 0, 2, 4 (primary endpoint), and 8-months, the target parent/adolescent dyad and other untreated children and caregivers in the home will complete anthropometric assessments.
Results will determine the familial reach of TEENS+ and reveal potential mediators of treatment response, which can inform future efforts to optimize family-based lifestyle interventions.
TEENS + REACH was retrospectively registered in Clinicaltrials.gov March 22, 2023 (NCT05780970) as an observational study ancillary to the TEENS + clinical trial, registered February 22, 2019 (NCT03851796).
鉴于肥胖是一种家族性疾病，且青少年的治疗成功与更广泛的家庭变化之间可能存在双向关系，了解基于家庭的生活方式干预对接受治疗的青少年之外的人的影响非常重要。然而，尚不清楚是否采用了建议的全家庭范围的改变，以及未接受治疗的家庭成员是否能从体重相关的改善中获益。
“青少年+家庭影响研究（TEENS + REACH）”利用我们正在进行的针对肥胖青少年的基于家庭的生活方式干预“青少年+（TEENS+）”随机临床试验，以确定：1）是否在全家庭范围内对共享的家庭环境进行了改变；2）是否观察到对未接受治疗的家庭成员的连锁反应；3）这些改变是否能预测青少年体重管理的成功。“青少年+家庭影响研究（TEENS + REACH）”将扩大试验评估范围，包括对目标青少年共享的家庭饮食、体重和身体活动环境进行全面评估。具体而言，我们将招募与目标父母/青少年二元组居住在同一家庭中的未接受治疗的儿童（8至17岁）及其照顾者（N = 60个家庭）。在第0、2、4个月（主要终点）和8个月时，目标父母/青少年二元组以及家中其他未接受治疗的儿童和照顾者将完成人体测量评估。
研究结果将确定“青少年+（TEENS+）”的家庭影响范围，并揭示治疗反应的潜在调节因素，这可为未来优化基于家庭的生活方式干预的努力提供参考。
“青少年+家庭影响研究（TEENS + REACH）”于2023年3月22日在Clinicaltrials.gov上进行了回顾性注册（NCT05780970），作为2019年2月22日注册的“青少年+（TEENS+）”临床试验（NCT03851796）的一项观察性研究附属试验。
