Accepted for/Published in: JMIR Research Protocols
Date Submitted: Jan 17, 2023
Date Accepted: Apr 5, 2023
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Comparing implementation strategies for an evidence-based weight management program delivered in community mental health programs: Protocol for a pilot randomized controlled trial
ABSTRACT
Background:
Among persons with serious mental illness (SMI), obesity contributes to increased cardiovascular disease (CVD) risk. The Achieving Healthy Lifestyles in Psychiatric Rehabilitation (ACHIEVE) randomized controlled trial (RCT) demonstrated that a behavioral intervention tailored to the needs of individuals with SMI results in clinically significant weight loss. While the research team delivered the ACHIEVE intervention in the trial, community mental health program staff are needed to deliver sessions to make scale-up feasible. Therefore, we adapted the ACHIEVE-Dissemination (ACHIEVE-D) curriculum to ease adoption and implementation in this setting. Designing and testing of implementation strategies is now needed to understand how to support ACHIEVE-D delivery by community mental health program staff coaches.
Objective:
To conduct a pilot trial evaluating standard and enhanced implementation interventions to support delivery of ACHIEVE-D in community mental health programs by examining effects on staff coaches’ knowledge, self-efficacy, and delivery fidelity of the curriculum. Secondarily, we will examine effects on outcomes among individuals with SMI taking part in the curriculum.
Methods:
The trial will be a cluster-randomized, two-arm parallel pilot RCT comparing standard and enhanced implementation interventions at 6 months within community mental health programs. We will randomly assign programs to either the standard or enhanced implementation interventions. The standard intervention will combine multimodal training for coaches (real-time initial training via videoconference, ongoing online training, and online avatar-assisted motivational interviewing practice) with organizational strategy meetings to garner leadership support for implementation. The enhanced intervention will include all standard strategies and the coaches will receive performance coaching. At each program, we will enroll staff to participate as coaches and clients with SMI to participate in the curriculum. Coaches will deliver the ACHIEVE-D curriculum to clients with SMI. Primary outcomes will be coaches’ knowledge, self-efficacy, and fidelity to the ACHIEVE-D curriculum. We also will examine the acceptability, feasibility and appropriateness of ACHIEVE-D and the implementation strategies. Secondary outcomes among individuals with SMI will be weight and self-reported lifestyle behaviors.
Results:
Data collection started March 2021 with completion estimated in March 2023. We recruited 9 sites and a total of 20 staff coaches and 72 clients with SMI. Expected start of data analyses will occur in March 2023 with primary results submitted for publication in April 2023.
Conclusions:
Community mental health programs may be an ideal setting for implementing an evidence-based weight-management curriculum for individuals with SMI. This pilot study will contribute knowledge about implementation strategies to support community-based delivery of such programs, which will be key to informing future research that definitively tests implementation and dissemination of behavioral weight management programs. Clinical Trial: Clinicaltrials.gov, NCT03454997; https://clinicaltrials.gov/ct2/show/NCT03454997.
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