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 people 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 This study aims to conduct a pilot trial evaluating standard and enhanced implementation interventions to support the delivery of ACHIEVE-D in community mental health programs by examining effects on staff coaches’ knowledge, self-efficacy, and delivery fidelity of the curriculum. We will also examine the effects on outcomes among individuals with SMI taking part in the curriculum. Methods The trial will be a cluster-randomized, 2-arm parallel pilot RCT comparing standard and enhanced implementation intervention 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 virtual training, and web-based 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 the clients with SMI. Primary outcomes will be coaches’ knowledge, self-efficacy, and fidelity to the ACHIEVE-D curriculum. We will also 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 in March 2021, with completion estimated in March 2023. We recruited 9 sites and a total of 20 staff coaches and 72 clients with SMI. The 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 the community-based delivery of such programs, which may inform future research that definitively tests the implementation and dissemination of behavioral weight management programs. Trial Registration ClinicalTrials.gov NCT03454997; https://clinicaltrials.gov/ct2/show/NCT03454997 International Registered Report Identifier (IRRID) DERR1-10.2196/45802

Implementing an evidence‐based behavioral weight‐loss program in community mental health centers: A randomized pilot study

“…The Johns Hopkins University School of Medicine Institutional Review Board approved this study (IRB00247344). The full protocol for this study has been published previously 18 …”

“…This 6-month program was adapted from the ACHIEVE intervention for delivery by community mental health program staff. 17,18 Sites delivering in-person sessions provided exercise counseling rather than group exercise to limit the risk of COVID-19 transmission. Sessions occurred at least once a week and up to three times a week based on site integration and staffing resources.…”

“…For fidelity, each coach had their delivery of an ACHIEVE-D group session video-recorded once a month, and the masked research team rated their performance using the ACHIEVE-D Program Fidelity tool. 18 Staff-coaches were recorded delivering either the second or third lesson for each 4-week module. Of note, recordings occurred for whichever staff-coach was routinely scheduled to deliver the module-the study team did not require unscheduled staff-coaches (e.g., alternate/back-up staff-coaches) to deliver sessions for the sole purpose of data collection.…”

“…The pre-conditions phase translated the ACHIEVE intervention into the ACHIEVE-Dissemination (ACHIEVE-D) program. 17,18 In brief, ACHIEVE-D is an adapted 6-month curriculum designed for delivery by mental health center staff, which has weekly, 45-min multi-purpose group sessions structured to include behavioral weight-management lessons and group exercise (26 modules over 6 months) as compared to the 18-month ACHIEVE intervention that included both individual and group sessions delivered by a trained interventionist. A non-randomized proof-ofconcept study was previously conducted at a single PRP in Maryland to determine the acceptability of ACHIEVE-D-study staff delivered the adapted curriculum to clients with SMI, which was observed by mental health center staff.…”

“…This model has four stages: pre‐conditions, pre‐implementation, implementation, and maintenance. The pre‐conditions phase translated the ACHIEVE intervention into the ACHIEVE‐Dissemination (ACHIEVE‐D) program 17,18 . In brief, ACHIEVE‐D is an adapted 6‐month curriculum designed for delivery by mental health center staff, which has weekly, 45‐min multi‐purpose group sessions structured to include behavioral weight‐management lessons and group exercise (26 modules over 6 months) as compared to the 18‐month ACHIEVE intervention that included both individual and group sessions delivered by a trained interventionist.…”