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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Diet Habit

Intervention / Treatment
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* Behavioral: MP
* Behavioral: Call
* Behavioral: MesC


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: Participants with a medically diagnosed history of eating disorders or disordered eating will be asked to self-exclude from the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: Sequential Multiple Assignment Randomized Trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Part I: Non-Digital (Control)<br>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). | |
| Experimental: Part I: MP+ Call + MesC [6 weeks]<br>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. | Behavioral: MP<br>* 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.<br>Behavioral: Call<br>* 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.<br>Behavioral: MesC<br>* 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.<br>|
| Experimental: Part II: Stage 1- MP [1week]<br>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. | Behavioral: MP<br>* 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.<br>|
| Experimental: Part II: Stage 2 - R1-MP [1 week]<br>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. Participants' response status is dependent on whether they are randomised to using the stringent or relaxed engagement criteria as described in study details. | Behavioral: MP<br>* 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.<br>|
| Experimental: Part II: Stage 2 - NR1-MP [1 week]<br>For participants in Part II: Stage 1- MP [1week], after the first 1 week, this group of participants are considered non-responders (NR1) and are re-randomised to continue with MP only for another 1 week. Participants' response status is dependent on whether they are randomised to using the stringent or relaxed engagement criteria as described in study details. | Behavioral: MP<br>* 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.<br>|
| Experimental: Part II: Stage 2 - NR1-MP + Call + MesC [1 week]<br>For participants in Part II: Stage 1- MP [1 week], after the first 1 week, this group of participants are considered non-responders (NR1) and are re-randomised to have MP and additional coach support for another 1 week. The coach support consists of up to 3 coach-initiated messaging and ad-hoc calls to participant. Participants' response status is dependent on whether they are randomised to using the stringent or relaxed engagement criteria as described in study details. | Behavioral: MP<br>* 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.<br>Behavioral: Call<br>* 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.<br>Behavioral: MesC<br>* 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.<br>|
| Experimental: Part II: Stage 3 - R2-MP [2 weeks]<br>After going through Part II: Stage 2, this group of participants are considered responders (R2) so they continue with MP only for 2 weeks. Participants' response status is dependent on whether they are randomised to using the stringent or relaxed engagement criteria as described in study details. | Behavioral: MP<br>* 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.<br>|
| Experimental: Part II: Stage 3 - NR2-MP [2 weeks]<br>After going through Part II: Stage 2, this group of participants are considered non-responders (NR2) and are re-randomised to use MP only for another 2 week. Participants' response status is dependent on whether they are randomised to using the stringent or relaxed engagement criteria as described in study details. | Behavioral: MP<br>* 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.<br>|
| Experimental: Part II: Stage 3 - NR2-MP + Call + MesC [2 weeks]<br>After going through Part II: Stage 2, this group of participants are considered non-responders (NR2) and are re-randomised to have MP and additional coach support for another 2 weeks. The coach support consists of up to 3 coach-initiated messaging and ad-hoc calls to participant. Participants' response status is dependent on whether they are randomised to using the stringent or relaxed engagement criteria as described in study details. | Behavioral: MP<br>* 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.<br>Behavioral: Call<br>* 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.<br>Behavioral: MesC<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success rates of carbohydrate periodisation behaviour at week 4, 6 | A binary success of whether dietary periodisation behaviour has improved in the participant measured by the periodisation behaviour questionnaire (in the process of submitting the paper on validation of questionnaire). The scale is 1- does not periodise, 2-periodises energy but not carbohydrate, and 3-periodises both. Higher score indicates better periodisation behaviour. Only score of 3 is considered success. | At week 6 (for part I of study) and week 4 (part II of study) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in dietary self-efficacy from baseline to week 4, 6 | The dietary self-efficacy will be assessed using a self-efficacy scale. This questionnaire have been validated in the general population (Stich, Knauper and Tint, 2009). The scale is a 5-point scale from 1 for not confident at all, to 5 for very confident. Higher score indicates higher self-efficacy. | At baseline (week 0) and at week 6 (for part I of study) and week 4 (part II of study) | 
| Change in beliefs about consequences from baseline to week 4, 6. | The beliefs about consequences scale has not yet been validated but has been adapted from previous research on beliefs about capabilities by Wallin, Boström and Gustavsson (2012). The scale is a 5-point sale from 1- not at all to 5- extremely. Higher scores indicate higher beliefs about consequences. | At baseline (week 0) and at week 6 (for part I of study) and week 4 (part II of study) | 
| Change in body weight from baseline to week 4,6 | Self-reported weight (in kg/lbs) collected at baseline and at week 6 (for part I of study) and week 4 (part II of study) | Baseline(week 0) and at week 6 (for part I of study) and week 4 (part II of study) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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carbohydrate periodisation, mobile app, nutrition, adaptive design, behaviour change, digital intervention, sports performance, technology