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

Liverpool John Moores University

Status: Unknown

Conditions: Diet Habit

Treatments: Behavioral: Call; Behavioral: MesC; Behavioral: MP

Study type: Interventional

Funder types: Other

Identifiers

NCT04487015

20/NSP/027

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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1,000 participants in 9 patient groups

Part I: Non-Digital (Control)

No Intervention group

Description:

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 group

Description:

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.

Treatment:

Behavioral: MesC

Behavioral: Call

Behavioral: MP

Part II: Stage 1- MP [1week]

Experimental group

Description:

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.

Treatment:

Behavioral: MP

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

Experimental group

Description:

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.

Treatment:

Behavioral: MP

Part II: Stage 2 - NR1-MP [1 week]

Experimental group

Description:

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.

Treatment:

Behavioral: MP

Part II: Stage 2 - NR1-MP + Call + MesC [1 week]

Experimental group

Description:

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.

Treatment:

Behavioral: MesC

Behavioral: Call

Behavioral: MP

Part II: Stage 3 - R2-MP [2 weeks]

Experimental group

Description:

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.

Treatment:

Behavioral: MP

Part II: Stage 3 - NR2-MP [2 weeks]

Experimental group

Description:

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.

Treatment:

Behavioral: MP

Part II: Stage 3 - NR2-MP + Call + MesC [2 weeks]

Experimental group

Description:

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.

Treatment:

Behavioral: MesC

Behavioral: Call

Behavioral: MP