A Digital Approach to Improving Carbohydrate Periodisation Behaviours in Athlete: SMART+ Study
NCT ID: NCT04487015
Last Updated: 2020-11-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
1000 participants
INTERVENTIONAL
2020-09-14
2020-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
SEQUENTIAL
OTHER
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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).
No interventions assigned to this group
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
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.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
18 Years
55 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Applied Behaviour Systems Ltd
UNKNOWN
University College, London
OTHER
Duke-NUS Graduate Medical School
OTHER
Liverpool John Moores University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
David Dunne
PhD Student
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Liverpool John Moores University
Liverpool, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
David Dunne, PGDip
Role: primary
References
Explore related publications, articles, or registry entries linked to this study.
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.
Dunne 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.
Yan 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.
Bentley 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.
Heikura 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.
Heikura 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.
Mazorra 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).
Soto 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.
Stich 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.
Smit 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.
Wallin 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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
20/NSP/027
Identifier Type: -
Identifier Source: org_study_id