ABSTRACT

Primary objective

Interventions are needed to address chronic health conditions, such as obesity and diabetes, faced by adults with traumatic brain injury (TBI). The objective of this narrative is to present the justification for and an exemplar of an active attention control condition as a needed comparison group in clinical trials for intensive lifestyle interventions after TBI.

Research Design

Narrative review

Methods and Procedures

N/A

Main Outcomes and Results

Despite the historical use in scientific research, integration of appropriate control conditions to account for not only the placebo effect, but also to isolate the “active ingredients” of behavioural interventions, remains a challenge. This is particularly true for intensive lifestyle interventions, especially with the increasing use of mobile health (mHealth) to augment these interventions. Herein we describe the design, content, and implementation of a group-based, attention control condition, referred to as the Brain Health Group, as an exemplar active comparison to an intensive lifestyle intervention for weight-loss among individuals with TBI (GLB-TBI).

Conclusions

Intervention studies should incorporate strong scientific designs and active control conditions to assess effectiveness and aid in replication. Following recommended guidelines, we provide an active control condition for future group-based intensive lifestyle interventions post-TBI.

中文翻译：

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给予同等关注：设计对照组，进行脑损伤后的强化生活方式干预

摘要

主要目标

需要采取干预措施来解决成年人患有颅脑损伤（TBI）所面临的慢性健康状况，例如肥胖和糖尿病。该叙述的目的是提出积极注意控制条件的理由和示例，作为在进行TBI后进行强化生活方式干预的临床试验中所需的比较组。

研究设计

叙事评论

方法与程序

不适用

主要结果和结果

尽管在科学研究中有历史性用途，但整合适当的控制条件不仅要考虑安慰剂的作用，而且要隔离行为干预的“有效成分”，仍然是一个挑战。对于密集的生活方式干预尤其如此，尤其是随着越来越多地使用移动医疗（mHealth）来增强这些干预措施时。本文中，我们描述了基于小组的注意力控制条件（称为“脑部健康小组”）的设计，内容和实现，作为对TBI（GLB-TBI）个体进行减肥的强化生活方式干预的典型积极比较）。

结论

干预研究应纳入强有力的科学设计和积极的控制条件，以评估有效性和辅助复制。遵循推荐的准则，我们为TBI之后的未来基于小组的强化生活方式干预提供了积极的控制条件。