Diet HabitNCT04487015
A Digital Approach to Improving Carbohydrate Periodisation Behaviours in Athlete: SMART+ Study
A study testing MP, Call and MesC in people with Diet Habit, run by Liverpool John Moores University at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Diet Habit
- What is being tested?
- MP, Call and MesC
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 14 Sep 2020to Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- Participants with a medically diagnosed history of eating disorders or disordered eating will be asked to self-exclude from the study.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Liverpool John Moores University
Liverpool, L3 3AF
David Dunne, PGDip, +44 7798872877
About this study
Official title: 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.
Read the 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.
- Conditions
- Diet Habit
- Being tested
- MP, Call, MesC
- Keywords
- carbohydrate periodisation, mobile app, nutrition, adaptive design, behaviour change, digital intervention, sports performance, technology
- Medical subject headings
- Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MPBehavioural
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.
CallBehavioural
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.
MesCBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Part I: Non-Digital (Control) | No intervention | 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 | 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. Receives: Behavioral: MP; Behavioral: Call; Behavioral: MesC |
| Part II: Stage 1- MP [1week] | Experimental | 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. Receives: Behavioral: MP |
| Part II: Stage 2 - R1-MP [1 week] | Experimental | 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. Receives: Behavioral: MP |
| Part II: Stage 2 - NR1-MP [1 week] | Experimental | 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. Receives: Behavioral: MP |
| Part II: Stage 2 - NR1-MP + Call + MesC [1 week] | Experimental | 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. Receives: Behavioral: MP; Behavioral: Call; Behavioral: MesC |
| Part II: Stage 3 - R2-MP [2 weeks] | Experimental | 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. Receives: Behavioral: MP |
| Part II: Stage 3 - NR2-MP [2 weeks] | Experimental | 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. Receives: Behavioral: MP |
| Part II: Stage 3 - NR2-MP + Call + MesC [2 weeks] | Experimental | 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. Receives: Behavioral: MP; Behavioral: Call; Behavioral: MesC |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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.
Measured: 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)
Measured: Baseline(week 0) and at week 6 (for part I of study) and week 4 (part II of study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2020
- Study start14 Sep 2020
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Diet HabitStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Sequential Multiple Assignment Randomized Trial
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Liverpool John Moores University
- Sponsor type
- University, hospital or other
- Collaborators
- Applied Behaviour Systems Ltd, University College, London, Duke-NUS Graduate Medical School
- Responsible party
- Principal investigator, David Dunne, Liverpool John Moores University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04487015
- Sponsor's protocol ID
- 20/NSP/027
- Status last verified
- Nov 2020
- First submitted
- 22 Jul 2020
- Last updated
- 27 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 29453741Dunne 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.
PubMed 31345110Yan 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.
PubMed 32529788Bentley 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.
PubMed 32112958Heikura 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.
PubMed 30559680Heikura 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.
PubMed 28387576Mazorra 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.
PubMed 18703821Smit 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.
PubMed 22458331
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Approaches to Improve Carbohydrate Periodisation Behaviour in Athletes Using a Pilot Sequential Multiple Assignment Randomised Trial Design.
- ClinicalTrials.gov ID
- NCT04487015
- Acronym / sponsor ID
- 20/NSP/027
- Conditions
- Diet Habit
- Keywords
- carbohydrate periodisation, mobile app, nutrition, adaptive design, behaviour change, digital intervention, sports performance, technology
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Liverpool John Moores UniversityUniversity, hospital or other
- Collaborators
- Applied Behaviour Systems Ltd, University College, London, Duke-NUS Graduate Medical School
- Study start
- 14 Sep 2020 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 27 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 9
- Model description
- Sequential Multiple Assignment Randomized Trial
| Arm | Type | Receives |
|---|---|---|
| Part I: Non-Digital (Control) | No intervention | –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 | Behavioral: MP, Behavioral: Call, Behavioral: MesCFor 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] | Experimental | Behavioral: MPFor 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] | Experimental | Behavioral: MPFor 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] | Experimental | Behavioral: MPFor 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] | Experimental | Behavioral: MP, Behavioral: Call, Behavioral: MesCFor 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] | Experimental | Behavioral: MPAfter 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] | Experimental | Behavioral: MPAfter 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] | Experimental | Behavioral: MP, Behavioral: Call, Behavioral: MesCAfter 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- Participants with a medically diagnosed history of eating disorders or disordered eating will be asked to self-exclude from the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MPThe 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. | Behavioural | Part I: MP+ Call + MesC [6 weeks], Part II: Stage 1- MP [1week], Part II: Stage 2 - NR1-MP + Call + MesC [1 week], Part II: Stage 2 - NR1-MP [1 week], Part II: Stage 2 - R1-MP [1 week], Part II: Stage 3 - NR2-MP + Call + MesC [2 weeks], Part II: Stage 3 - NR2-MP [2 weeks], Part II: Stage 3 - R2-MP [2 weeks] |
| CallA 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. | Behavioural | Part I: MP+ Call + MesC [6 weeks], Part II: Stage 2 - NR1-MP + Call + MesC [1 week], Part II: Stage 3 - NR2-MP + Call + MesC [2 weeks] |
| MesCNutrition 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. | Behavioural | Part I: MP+ Call + MesC [6 weeks], Part II: Stage 2 - NR1-MP + Call + MesC [1 week], Part II: Stage 3 - NR2-MP + Call + MesC [2 weeks] |
Primary outcome
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.
3 secondary outcomes
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)
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)
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2020.
- Background: PubMed 29453741Impey 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.
- Background: PubMed 31345110Dunne 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.
- Background: PubMed 32529788Yan 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.
- Background: PubMed 32112958Bentley 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.
- Background: PubMed 30559680Heikura 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.
- Background: PubMed 28387576Heikura 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.
- BackgroundMazorra 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.
- Background: PubMed 18703821Stich 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.
- BackgroundSmit 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.
- Background: PubMed 22458331Wallin 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.
- Individual participant dataSharing planned: No. 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.
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Lifewise Preventive Video Education in Primary Care
Prevention Harmful Effects, Health Maintenance
Not yet recruiting
Project GAME ON! A Digital Comic Tool to Promote Healthy Behaviors
Obesity & Overweight, Childhood
Recruiting
SMART GOALS for Youth With Prediabetes
PreDiabetes, Adolescent Obesity
Recruiting
Can Food Timing Reduce Your Diabetes Risk?
Dietary Habits
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MP, Call and MesC in people with Diet Habit, run by Liverpool John Moores University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact David Dunne, PGDip (+44 7798872877, d.m.dunne@2015.ljmu.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04487015, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2020.