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

Liverpool John Moores University1 个研究点分布在 1 个国家目标入组 1,000 人开始时间: 2020年9月14日最近更新: 2020年11月27日

适应症

干预措施

试验速览

阶段: 不适用
发起方: Liverpool John Moores University
入组人数: 1,000
试验地点: 1
主要终点: Success rates of carbohydrate periodisation behaviour at week 4, 6

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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.

详细描述

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,

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Sequential
主要目的: Other
盲法: None

入排标准

年龄范围: 18 Years 至 55 Years（Adult）
性别: All
接受健康志愿者: 是

入选标准

•Have access to a personal smart phone.
•An elite or training athlete.
•Have a performance related weight loss or weight maintenance physical goal.
•Do not have or have not have a history of eating disorders or disordered eating.

排除标准

•Participants with a medically diagnosed history of eating disorders or disordered eating will be asked to self-exclude from the study.

研究组 & 干预措施

Part I: Non-Digital (Control)

No Intervention

Participants who currently receive performance nutrition support, via a qualified practitioner as indicated by a member of the sports science team at their sporting organisation, will be assigned to the non-digital approach (control). These participants will not receive any intervention from the research team for the duration of this study (6 weeks).

Part I: MP+ Call + MesC [6 weeks]

Experimental

For part one of study, participants who currently do not receive performance nutrition support, will be given access to an app-based menu planner (MP) for 6 weeks with coach support that gives ad-hoc messaging and calls.

干预措施: MP (Behavioral)

Part I: MP+ Call + MesC [6 weeks]

Experimental

干预措施: Call (Behavioral)

Part I: MP+ Call + MesC [6 weeks]

Experimental

干预措施: MesC (Behavioral)

Part II: Stage 1- MP [1week]

Experimental

For the pilot SMART trial (part two of study), participants (not the same participants as part one) who currently do not receive performance nutrition support, will be given access to a menu planner app (MP) for 4 weeks. In the first 1 week, participants will only receive MP.

干预措施: MP (Behavioral)

Part II: Stage 2 - R1-MP [1 week]

Experimental

For participants in Part II: Stage 1- MP [1week], after the first 1week, this group of participants are considered responders (R1) so they continue with MP only for another 1 week.