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

November 24, 2020 updated by: David Dunne, Liverpool John Moores University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

1000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United Kingdom
      • Liverpool, United Kingdom, L3 3AF
        • Recruiting
        • Liverpool John Moores University
        • Contact:
          • David Dunne, PGDip
          • Phone Number: +44 7798872877

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Part I: Non-Digital (Control)
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]
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
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.
Experimental: Part II: Stage 1- MP [1week]
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
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.
Experimental: Part II: Stage 2 - R1-MP [1 week]

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

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

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

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

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

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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Success rates of carbohydrate periodisation behaviour at week 4, 6
Time Frame: At week 6 (for part I of study) and week 4 (part II of study)
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
Time Frame: At baseline (week 0) and at week 6 (for part I of study) and week 4 (part II of study)
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.
Time Frame: At baseline (week 0) and at week 6 (for part I of study) and week 4 (part II of study)
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
Time Frame: Baseline(week 0) and at week 6 (for part I of study) and week 4 (part II of study)
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)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Personality traits on a BFI-2S questionnaire at baseline
Time Frame: At baseline (week 0)
The BFI-2S questionnaire (Soto and John, 2017) is a validated questionnaire to assess the Big Five Personality domains of an individual.
At baseline (week 0)
Level of need for autonomy on the nutrition causality orientation scale at baseline.
Time Frame: At baseline (week 0)
The nutrition causality orientation scale is a measure of the need for autonomy in nutrition-related decisions. It is not yet validated but is adapted from previous research on the validated health causality orientation scale (Smit and Bol, 2020). The scale is a 7-point scale, with 1 being strongly disagree to 7 being strongly agree.
At baseline (week 0)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Liverpool John Moores University

Collaborators

University College, London
Duke-NUS Graduate Medical School
Applied Behaviour Systems Ltd

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 14, 2020

Primary Completion (Anticipated)

December 1, 2020

Study Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

July 22, 2020

First Submitted That Met QC Criteria

July 22, 2020

First Posted (Actual)

July 27, 2020

Study Record Updates

Last Update Posted (Actual)

November 27, 2020

Last Update Submitted That Met QC Criteria

November 24, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 20/NSP/027

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The deidentified individual participant data may be shared with other researchers on a case by case basis upon request and subject to Data Protection Officer approval.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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