一项结构化的、基于手册的低水平干预与常规治疗在青少年极度肥胖随机对照试验中的评估——STEREO试验

A Structured, Manual-Based Low-Level Intervention vs. Treatment as Usual Evaluated in a Randomized Controlled Trial for Adolescents with Extreme Obesity - the STEREO Trial.

作者信息

Mühlig Yvonne, Scherag André, Bickenbach Annika, Giesen Ulrike, Holl Reinhard, Holle Rolf, Kiess Wieland, Lennerz Belinda, Lütke Brintrup Diana, Moss Anja, Neef Madlen, Ose Claudia, Reinehr Thomas, Teuner Christina M, Wiegand Susanna, Wolters Barbara, Wabitsch Martin, Hebebrand Johannes

机构信息

Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, University Hospital Essen, University of Duisburg-Essen, Essen, Germany.

出版信息

Obes Facts. 2017;10(4):341-352. doi: 10.1159/000475717. Epub 2017 Aug 9.

DOI:10.1159/000475717

PMID:28787738

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5644941/

Abstract

BACKGROUND

To compare efficacy and safety of a manual-based low-level psychological intervention with treatment as usual (weight loss treatment).

METHODS

A two-armed randomized controlled trial without blinding and computer-based stratified block randomization included adolescents and young adults (14.0-24.9 years) with a BMI ≥ 30 kg/m2 at five German university hospitals. Primary outcomes were adherence (participation rate ≥ 5/6 sessions) and quality of life (DISABKIDS-37) 6 months after randomization. Secondary outcomes included depression, self-esteem, and perceived stress scores.

RESULTS

Of 397 screened adolescents, 119 (mean BMI 40.4 ± 7.0 kg/m2, 49.6% female) were randomized to the manual-based low-level intervention (n = 59) or treatment as usual (n = 60). We observed no group difference for adherence (absolute risk reduction 0.4%, 95% CI -14.7% to 15.5%; p = 1.0) or health-related quality of life (score difference 8.1, 95% CI -2.1 to 18.3; p = 0.11). Among all secondary outcomes, we detected explorative evidence for an effect on the DISABKIDS-37 'social exclusion' subscale (score difference 15.5; 95% CI 1.6-29.4; p = 0.03). 18/19 adverse events occurred in 26 participants, none were classified as serious.

CONCLUSION

Adherence to a coping-oriented intervention was comparable to weight loss treatment, although it was weak in both interventions. Psychological interventions may help to overcome social isolation; further confirmation is required.

摘要

背景

比较基于手册的低强度心理干预与常规治疗（减肥治疗）的疗效和安全性。

方法

一项双臂随机对照试验，未设盲法，采用基于计算机的分层区组随机化，纳入了德国五所大学医院中BMI≥30kg/m²的青少年和青年（14.0 - 24.9岁）。主要结局指标为随机分组6个月后的依从性（参与率≥5/6次疗程）和生活质量（儿童残疾评定量表-37）。次要结局指标包括抑郁、自尊和感知压力得分。

结果

在397名筛查的青少年中，119名（平均BMI 40.4±7.0kg/m²，49.6%为女性）被随机分配至基于手册的低强度干预组（n = 59）或常规治疗组（n = 60）。我们观察到两组在依从性（绝对风险降低0.4%，95%CI -14.7%至15.5%；p = 1.0）或健康相关生活质量（得分差异8.1，95%CI -2.1至18.3；p = 0.11）方面无差异。在所有次要结局指标中，我们发现有探索性证据表明对儿童残疾评定量表-37的“社会排斥”子量表有影响（得分差异15.5；95%CI 1.6 - 29.4；p = 0.03）。26名参与者发生了18/19起不良事件，均未被分类为严重不良事件。