Study protocol for a randomized, parallel-group trial to compare the effectiveness of registered dietitian and occupational therapy services on fall risk among home-delivered meal recipients

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BACKGROUND: Home-delivered meal recipients are among the most susceptible to fall-related morbidity and mortality given their complex health characteristics. While meal services funded through federal appropriations aim to reduce malnutrition and promote health, the provision of meals alone may be insufficient for mitigating the extensive fall risk factors this population experiences. To reduce fall risk among older adults, this study protocol presents our methods to test the effectiveness of integrating registered dietitian nutritionist (RDN) and occupational therapy (OT) services into home-delivered meal programming. METHODS: We will conduct a four-arm, parallel group, randomized controlled trial with 608 households recruited from a community-based agency in the Midwest United States. We will apply a novel, minimal sufficient balance randomization process to ensure baseline covariates are balanced across the following four treatment arms: (1) meals alone, (2) meals + RDN services, (3) meals + OT services, and (4) meals + RDN + OT services. Our primary outcome – perceived fall risk – will be measured using the Short Falls Efficacy Scale-International (FES-I), and secondary and exploratory outcomes include risk of malnutrition, dietary intake, healthcare utilization, and quality of life. We will also conduct semi-structured interviews with a subsample of participants to understand their experiences receiving meals, RDN, and OT services. DISCUSSION: This study will provide valuable evidence on the effectiveness of integrating RDN and OT services into home-delivered meal programs. The insights gained will inform policy decisions, guide practical applications, and pave the way for future research to further explore how tailored clinical services can optimize the impact of home-delivered meals for community-dwelling older adults. TRIAL REGISTRATION: Clinicaltrials.gov NCT06059404 22/09/2023.

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