Contemporary Clinical Trials Communications (Apr 2022)
A pilot sequential multiple assignment randomized trial (SMART) protocol for developing an adaptive coaching intervention around a mobile application for athletes to improve carbohydrate periodization behavior
Abstract
Background: It has recently been identified that manipulating carbohydrate availability around exercise activity can enhance training-induced metabolic adaptations. Despite this approach being accepted in the athletic populations, athletes do not systematically follow the guidelines. Digital environments appear to allow nutritionists to deliver this intervention at scale, reducing expensive human coaching time. Yet, digitally delivered dietary behavior change interventions for athletes and the coaching strategy to support them are still novel concepts within sports nutrition. Methods/design: We aim to recruit 900 athletes across the UK. 500 athletes will be recruited to test the feasibility of a novel menu planner mobile application with coaching for 6 weeks. 250 athletes with pre-existing nutritionist support will also be recruited as control. We will then conduct a 4-week pilot sequential multiple assignment randomized trial (SMART) with an additional 150 athletes. In the SMART, athletes will be given the application and additional coaching according to their engagement responses. The primary outcomes are the mobile application and coach uptake, retention, engagement, and success in attaining carbohydrate periodization behavior. Secondary outcomes are changes in goal, weight, carbohydrate periodization self-efficacy, and beliefs about consequences. Due to the high attrition nature of digital interventions, all quantitative analyses will be carried out based on both the intention-to-treat and per-protocol principles. Discussion: This study will be the first to investigate improving carbohydrate periodization using a digital approach and tailored coaching strategies under this context. Foundational evidence from this study will provide insights into the feasibility of the digital approach.
