NCT04487015

A Digital Approach to Improving Carbohydrate Periodisation Behaviours in Athlete: SMART+ Study

Digital Approaches to Improve Carbohydrate Periodisation Behaviour in Athletes Using a Pilot Sequential Multiple Assignment Randomised Trial Design.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,000 (estimated)
• Sponsor: Liverpool John Moores University · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The carbohydrate periodisation framework is a widely accepted nutritional intervention strategy in the field of sports nutrition. However, despite the validity of this approach, it is reported that athletes find it difficult to stick to this behaviour and that the support required is highly personalised, and as a result time consuming for the coach. Prior research has suggested that a digital environment can deliver better personalised dietary interventions to better support athletes. The overall purpose of this study is to assess the feasibility and acceptability of a digital approach (a menu planner app with coach support), and gain understanding on the strategy to implement coach support according to app engagement in the digital approach to improve dietary carbohydrate periodisation behaviours in athletes.

Detailed description

The study is conducted in two consecutive parts. For part one, to assess the feasibility and acceptability of the digital approach, participants are recruited to use the app for 6 weeks and were given coach support, where coaches message (MesC) and call (ad-hoc Call) and the participants. A control group (no app) is also separately recruited to compare with the menu planner group. For part two, to gain better understanding on the strategy to implement coach support with the menu planner app according to app engagement, a pilot multiple assignment randomized trial (SMART) design is conducted. Participants are equally randomised to either receive a stringent engagement criteria strategy or relaxed adherence criteria strategy. A stringent engagement criteria strategy requires the user to use the app at least twice a week at stage 1, and at least 3 times a week at stage 2 to be considered a responder at stage 1 and stage 2 (R1 and R2). A relaxed engagement criteria strategy requires the user to use the app at least once a week in week 1 of using the app at stage 1, and at least 2 times a week at stage 2, to be considered a responder at stage 1 and stage 2 (R1 and R2). Non-responders for both criteria strategies at stage 1 and 2 (NR1 and NR2) will be re-randomised to either continue with the app only or additional coach support (MesC + ad-hoc Call). Timeline wise, Stage 1: Participants will first receive app for 1 week and will be categorised as responder (R1) or non-responders (NR1) at the end of the 1 week. Stage 2: Responders to stage 1 (R1) will continue with the menu planner for 1 week. Non-responders to stage 1 (NR1) will either continue with the menu planner or receive additional coach support (MesC + ad-hoc Call) for 1 week. Participants are categorised again as responder (R2) or non-responders (NR2) at the end of the week. Stage 3: Responders to stage 2 (R2) will only have menu planner for 2 weeks. Non-responders to stage 2 (NR2) will either have menu planner only or receive/continue with additional coach support (MesC + ad-hoc Call) for 2 weeks. The SMART trial will take a total of 4 weeks to complete and have up to two randomisation points per participant. All re-randomisations are done at 1:1 allocation ratio.

Conditions

• Diet Habit

Interventions

Type	Name	Description
BEHAVIORAL	MP	The app-based menu planner (MP) given to the participants has an automated carbohydrate periodisation menu planning tool, an educational and motivational nutrition content (infographics, video and text articles), and recipes. Participants using the app will input their training schedule into the app to produce their own menu plans. The behaviour change techniques (BCT) underlying the intervention are goal \& planning, feedback \& monitoring, shaping knowledge, natural consequences, comparison of behaviour, comparison of outcome, associations, repetitions, reward \& threat, regulation and antecedents.
BEHAVIORAL	Call	A 30-45 minutes coaching consultation telephone/Skype call from the nutrition coaching to give social support. The BCT underlying the intervention is goal \& planning, social support, natural consequences.
BEHAVIORAL	MesC	Nutrition coach-led messaging (MesC) is where the mobile app (MP) has the text messaging feature activated, and the nutrition coach proactively initiates a conversation via text messaging up to three times a week to offer nutrition support to the participant. The BCT underlying the intervention is goal \& planning, social support, natural consequences.

Timeline

• Start date: 2020-09-14
• Primary completion: 2020-12-01
• Completion: 2020-12-01
• First posted: 2020-07-27
• Last updated: 2020-11-27

Locations

1 site across 1 country: United Kingdom