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.
1 other identifier
interventional
1,000
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2020
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 22, 2020
CompletedFirst Posted
Study publicly available on registry
July 27, 2020
CompletedStudy Start
First participant enrolled
September 14, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2020
CompletedNovember 27, 2020
November 1, 2020
3 months
July 22, 2020
November 24, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Change in dietary self-efficacy from baseline to week 4, 6
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.
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
Baseline(week 0) and at week 6 (for part I of study) and week 4 (part II of study)
Other Outcomes (2)
Personality traits on a BFI-2S questionnaire at baseline
At baseline (week 0)
Level of need for autonomy on the nutrition causality orientation scale at baseline.
At baseline (week 0)
Study Arms (9)
Part I: Non-Digital (Control)
NO INTERVENTIONParticipants 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]
EXPERIMENTALFor 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.
Part II: Stage 1- MP [1week]
EXPERIMENTALFor 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.
Part II: Stage 2 - R1-MP [1 week]
EXPERIMENTALFor 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.
Part II: Stage 2 - NR1-MP [1 week]
EXPERIMENTALFor 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.
Part II: Stage 2 - NR1-MP + Call + MesC [1 week]
EXPERIMENTALFor 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.
Part II: Stage 3 - R2-MP [2 weeks]
EXPERIMENTALAfter 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.
Part II: Stage 3 - NR2-MP [2 weeks]
EXPERIMENTALAfter 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.
Part II: Stage 3 - NR2-MP + Call + MesC [2 weeks]
EXPERIMENTALAfter 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.
Interventions
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Participants with a medically diagnosed history of eating disorders or disordered eating will be asked to self-exclude from the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Liverpool John Moores Universitylead
- Applied Behaviour Systems Ltdcollaborator
- University College, Londoncollaborator
- Duke-NUS Graduate Medical Schoolcollaborator
Study Sites (1)
Liverpool John Moores University
Liverpool, L3 3AF, United Kingdom
Related Publications (11)
Impey SG, Hearris MA, Hammond KM, Bartlett JD, Louis J, Close GL, Morton JP. Fuel for the Work Required: A Theoretical Framework for Carbohydrate Periodization and the Glycogen Threshold Hypothesis. Sports Med. 2018 May;48(5):1031-1048. doi: 10.1007/s40279-018-0867-7.
PMID: 29453741BACKGROUNDDunne DM, Lefevre C, Cunniffe B, Tod D, Close GL, Morton JP, Murphy R. Performance Nutrition in the digital era - An exploratory study into the use of social media by sports nutritionists. J Sports Sci. 2019 Nov;37(21):2467-2474. doi: 10.1080/02640414.2019.1642052. Epub 2019 Jul 26.
PMID: 31345110BACKGROUNDYan X, Ghosh P, Chakraborty B. Sample size calculation based on precision for pilot sequential multiple assignment randomized trial (SMART). Biom J. 2021 Feb;63(2):247-271. doi: 10.1002/bimj.201900364. Epub 2020 Jun 11.
PMID: 32529788BACKGROUNDBentley MRN, Mitchell N, Backhouse SH. Sports nutrition interventions: A systematic review of behavioural strategies used to promote dietary behaviour change in athletes. Appetite. 2020 Jul 1;150:104645. doi: 10.1016/j.appet.2020.104645. Epub 2020 Feb 27.
PMID: 32112958BACKGROUNDHeikura IA, Stellingwerff T, Burke LM. Self-Reported Periodization of Nutrition in Elite Female and Male Runners and Race Walkers. Front Physiol. 2018 Dec 3;9:1732. doi: 10.3389/fphys.2018.01732. eCollection 2018.
PMID: 30559680BACKGROUNDHeikura IA, Burke LM, Mero AA, Uusitalo ALT, Stellingwerff T. Dietary Microperiodization in Elite Female and Male Runners and Race Walkers During a Block of High Intensity Precompetition Training. Int J Sport Nutr Exerc Metab. 2017 Aug;27(4):297-304. doi: 10.1123/ijsnem.2016-0317. Epub 2017 Apr 7.
PMID: 28387576BACKGROUNDMazorra Blanco, Rodrigo; (2019) A Data Science approach to behavioural change: large scale interventions on physical activity and weight loss. Doctoral thesis (Ph.D), UCL (University College London).
BACKGROUNDSoto CJ, John OP. Short and extra-short forms of the Big Five Inventory-2: The BFI-2-S and BFI-2-XS. Journal of Research in Personality. 2017; 68:69-81.
BACKGROUNDStich C, Knauper B, Tint A. A scenario-based dieting self-efficacy scale: the DIET-SE. Assessment. 2009 Mar;16(1):16-30. doi: 10.1177/1073191108322000. Epub 2008 Aug 14.
PMID: 18703821BACKGROUNDSmit ES and Bol N. From self-reliers to expert-dependents: identifying classes based on health-related need for autonomy and need for external control among mobile users. Media Psychology. 2020; 23(3): 391-414.
BACKGROUNDWallin L, Bostrom AM, Gustavsson JP. Capability beliefs regarding evidence-based practice are associated with application of EBP and research use: validation of a new measure. Worldviews Evid Based Nurs. 2012 Aug;9(3):139-48. doi: 10.1111/j.1741-6787.2012.00248.x. Epub 2012 Mar 27.
PMID: 22458331BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD Student
Study Record Dates
First Submitted
July 22, 2020
First Posted
July 27, 2020
Study Start
September 14, 2020
Primary Completion
December 1, 2020
Study Completion
December 1, 2020
Last Updated
November 27, 2020
Record last verified: 2020-11
Data Sharing
- IPD Sharing
- Will not share
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.