Providing equal attention: designing control groups for intensive lifestyle interventions after brain injury

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.

KEYWORDS:

• Traumatic brain injuries
• clinical trials
• intensive lifestyle intervention
• weight-loss

Disclosure of interest

The authors report no conflict of interest.

Additional information

Funding

The contents of this manuscript were developed under a grant from The National Institute on Disability, Independent Living, and Rehabilitation Research (NIDILRR grant number 90DPTB0013). NIDILRR is a centre within the Administration for Community Living (ACL), Department of Health and Human Services (HHS). The contents of this manuscript do not necessarily represent the policy of NIDILRR, ACL, HHS, and you should not assume endorsement by the Federal Government.