ANZCTR - Registration

Registration number

ACTRN12623000768695

Ethics application status

Approved

Date submitted

14/06/2023

Date registered

14/07/2023

Date last updated

18/08/2024

Date data sharing statement initially provided

14/07/2023

Type of registration

Prospectively registered

Titles & IDs

Public title

Assessing the Efficacy of Promoting Performance Nutrition Behaviours in Enhancing Training-Induced Adaptations in Infantry Trainees: A Controlled Trial

Scientific title

Assessing the Efficacy of Promoting Performance Nutrition Behaviours in Enhancing Training-Induced Adaptations in Infantry Trainees: A Controlled Trial

Secondary ID [1]

None

Universal Trial Number (UTN)

U1111-1293-5618

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Low energy availability

Musculoskeletal injury

Stress fracture

Inadequate energy intake

Inadequate carbohydrate intake

Poor dietary intake

Condition category

Condition code

Diet and Nutrition

Other diet and nutrition disorders

Injuries and Accidents

Fractures

Musculoskeletal

Other muscular and skeletal disorders

Physical Medicine / Rehabilitation

Physiotherapy

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Volunteer Australian Army trainees undertaking their Infantry Initial Employment Training (Infantry IET) will be allocated to either the Control Group (usual practice) or Intervention Group (Diet and Education).

During week 1 of their 16-week Infantry IET, all participants in the intervention group will receive group education on the following two topics: 1) eating strategies to fuel performance, and 2) eating strategies to maximise muscle adaptations and recovery. This will be delivered in two x 1 hour face-to-face sessions (involving PowerPoint presentations and interactive activities) by an independent Accredited Sports Dietitian (i.e. not a member of the research team) who is qualified and experienced in helping athletes achieve their performance goals through nutrition. Participants' attendance at these sessions will be confirmed by an attendance checklist. To reinforce the content delivered in the lectures, trainees will receive 2 x 2-page handouts on the same two topics (that have been specifically created for this study). For the 16-week duration of their Infantry IET, trainees in the Diet and Education Intervention Group will receive access to additional foods in the common rooms of their accommodation lines that will be accompanied with a signs reading ‘Fuel Station’ and 'Recovery Station' with corresponding pictures of the foods they will provide: rapidly-digestible high-carbohydrate sports foods (i.e. Gatorade/Powerade carbohydrate-electrolyte sports drink, Science in Sport (SIS) Go Energy Isotonic Gels) and high-protein foods that are suitable snacks during recovery from Physical Training (PT) sessions (i.e. Sanitarium Up & Go Protein Energize, True Protein Protein Bars). Participants will be free to self-select these foods as they wish, however, in the lectures by the Sports Dietitian, volunteers in the intervention group will receive the recommendation to drink a 600 mL Gatorade or Powerade and in addition, if possible according to their personal choice and tolerance, consume an energy gel in the 10–15 minutes before commencing their morning PT sessions involving moderate-to-high intensity aerobic activity lasting 60 minutes or more. This will provide them with up to 58 g of carbohydrate, which is within with the optimal levels recommended immediately before and/or during endurance exercise lasting one hour or more and is a level that is unlikely to cause any gastrointestinal symptoms.

Additionally, participants in the intervention group will receive the recommendation to fill their 1 L drink bottles up with Gatorade/Powerade sports drinks (according to packet directions) and take this to any morning PT sessions involving moderate-to-high intensity aerobic training that lasts longer than 1 hour. It will be recommended that they drink 500 mL to 1 L of sports drink per hour (providing 30–60 g of carbohydrate), such as by consuming about 250 mL every 15–30 minutes, or 500 mL every 30 minutes to 1 hour, as time permits and according to their personal preference and tolerance. Participants may also choose to fill their drink bottle up with water, and take SIS Go Energy Isotonic Gels to their morning training sessions involving aerobic training. The Accredited Sports Dietitian and researchers will recommend that participants consume 1–2 SiS energy gels per hour (to target a total of 30–60 g of carbohydrate) during their PTI sessions involving moderate-to-high intensity aerobic activity that last longer than 60 minutes.

Intervention group participants' intake of foods/drinks from the Fuel and Recovery stations will be determined by food diaries administered on three training days during weeks 1, 7/8 and 16 of their Infantry IET.

In accordance with guidelines, volunteers will be encouraged to monitor and adjust their carbohydrate intakes up or down according to their personal tolerance and to find their optimal pre-exercise fueling routine.

Intervention code [1]

Behaviour

Intervention code [2]

Lifestyle

Comparator / control treatment

Trainees in the Control Group will not receive the education intervention and will commence their morning PT sessions as per their usual schedule (e.g. after finishing their breakfast in the mess / dining hall, or soon after waking up).

Control group

Active

Outcomes

Primary outcome [1]

Dietary intake (of energy, macronutrients and micronutrients) determined by direct photography of participants' plates before and after eating in the mess / dining hall (for all foods and drinks consumed in the mess / dining hall) as well as by collection of food diaries for any foods and drinks consumed outside of the mess / dining hall.

Timepoint [1]

Given primary outcomes are assessed at multiple timepoints, there is no primary timepoint. However, comparing any changes from baseline at 7 or 8 weeks and/or 16 weeks post-commencement between groups will be a primary endpoint of interest.

Primary outcome [2]

Performance in the multi-stage 20 m shuttle run

Timepoint [2]

Given primary outcomes are assessed at multiple timepoints, there is no primary timepoint. However, comparing any changes from baseline at 7 or 8 weeks and/or 16 weeks post-commencement between groups will be a primary endpoint of interest.

Primary outcome [3]

Fat-free mass measured in the early morning in the fasted state using the InBody 270 bioelectrical impedance analysis device

Timepoint [3]

Given primary outcomes are assessed at multiple timepoints, there is no primary timepoint. However, comparing any changes from baseline at 7 or 8 weeks and/or 16 weeks post-commencement between groups will be a primary endpoint of interest.

Secondary outcome [1]

Musculoskeletal injury surveillance through the following three methods:

1. Weekly completion of a modified version of the Oslo Sports Trauma Research Centre (OSTRC) Questionnaire on Health Problems (OSTRC-H)
2. The collection of musculoskeletal injury data from physiotherapy consults that occur with participants on an as-required basis
3. Collecting injury data from Sentinel, the Australian Defence Force's preferred method for notification and reporting of work, health and safety (WHS) incidents.

Musculoskeletal injury rates are additional primary outcomes.

Timepoint [1]

Musculoskeletal injury rates will be assessed throughout the 16 weeks of the Infantry Initial Training course and there is no primary timepoint. However, comparing any changes from baseline to any timepoint during the 16 weeks post-commencement between groups will be a secondary endpoint of interest.

Secondary outcome [2]

Serum total testosterone (in both males and females)

Timepoint [2]

Given secondary outcomes are assessed at multiple timepoints, there is no primary timepoint. However, comparing any changes from baseline at 16 weeks post-commencement between groups will be a secondary endpoint of interest.

Secondary outcome [3]

Self-reported gastrointestinal symptom severity as assessed by a questionnaire (that has been described by Jeukendrup et al., 2000)

Timepoint [3]

Given secondary outcomes are assessed at multiple timepoints, there is no primary timepoint. However, comparing any changes from baseline to 16 weeks post-commencement between groups will be a secondary endpoint of interest.

Secondary outcome [4]

1) Nutrition knowledge for sport as assessed by the abridged nutrition knowledge for sport (and exercise) questionnaire - this is an additional primary outcome.

Timepoint [4]

Given secondary outcomes are assessed at multiple timepoints, there is no primary timepoint. However, comparing any changes from baseline to 16 weeks post-commencement between groups will be a secondary endpoint of interest.

Secondary outcome [5]

Body weight measured in the early morning in the fasted state using the InBody 270 bioelectrical impedance analysis device - this is an additional primary outcome

Timepoint [5]

Given secondary outcomes are assessed at multiple timepoints, there is no primary timepoint. However, comparing any changes from baseline at 16 weeks post-commencement between groups will be a secondary endpoint of interest.

Secondary outcome [6]

Diet quality (intake of foods from each food group) determined by direct photography of participants' plates before and after eating in the mess / dining hall (for all foods and drinks consumed in the mess / dining hall) as well as by collection of food diaries for any foods and drinks consumed outside of the mess / dining hall. This is an additional primary outcome.

Timepoint [6]

Given secondary outcomes are assessed at multiple timepoints, there is no primary timepoint. However, comparing any changes from baseline at 7 or 8 weeks and/or 16 weeks post-commencement between groups will be a secondary endpoint of interest.

Secondary outcome [7]

Performance in an isometric mid-thigh pull test - this is an additional primary outcome

Timepoint [7]

Given secondary outcomes are assessed at multiple timepoints, there is no primary timepoint. However, comparing any changes from baseline at 7 or 8 weeks and/or 16 weeks post-commencement between groups will be a secondary endpoint of interest.

Secondary outcome [8]

Performance in a single repetition maximum box lift and place assessment - this is an additional primary outcome

Timepoint [8]

Given secondary outcomes are assessed at multiple timepoints, there is no primary timepoint. However, comparing any changes from baseline at 7 or 8 weeks and/or 16 weeks post-commencement between groups will be a secondary endpoint of interest.

Secondary outcome [9]

Performance in a standing broad jump assessment - this is an additional primary outcome

Timepoint [9]

Given secondary outcomes are assessed at multiple timepoints, there is no primary timepoint. However, comparing any changes from baseline at 7 or 8 weeks and/or 16 weeks post-commencement between groups will be a secondary endpoint of interest.

Secondary outcome [10]

Body fat mass measured in the early morning in the fasted state using the InBody 270 bioelectrical impedance analysis device - this is an additional primary outcome

Timepoint [10]

Given secondary outcomes are assessed at multiple timepoints, there is no primary timepoint. However, comparing any changes from baseline at 7 or 8 weeks and/or 16 weeks post-commencement between groups will be a secondary endpoint of interest.

Secondary outcome [11]

Serum free testosterone (in both males and females)

Timepoint [11]

Given secondary outcomes are assessed at multiple timepoints, there is no primary timepoint. However, comparing any changes from baseline to 16 weeks post-commencement between groups will be a secondary endpoint of interest.

Secondary outcome [12]

Serum bone-specific Alkaline Phosphatase (in both males and females)

Timepoint [12]

Given secondary outcomes are assessed at multiple timepoints, there is no primary timepoint. However, comparing any changes from baseline to 16 weeks post-commencement between groups will be a secondary endpoint of interest.

Secondary outcome [13]

Serum C-terminal telopeptide of type 1 collagen (in both males and females)

Timepoint [13]

Given secondary outcomes are assessed at multiple timepoints, there is no primary timepoint. However, comparing any changes from baseline to 16 weeks post-commencement between groups will be a secondary endpoint of interest.

Secondary outcome [14]

Serum oestradiol (in females only)

Timepoint [14]

Given secondary outcomes are assessed at multiple timepoints, there is no primary timepoint. However, comparing any changes from baseline at 16 weeks post-commencement between groups will be a secondary endpoint of interest.

Secondary outcome [15]

Serum progesterone (in females only)

Timepoint [15]

Given secondary outcomes are assessed at multiple timepoints, there is no primary timepoint. However, comparing any changes from baseline at 16 weeks post-commencement between groups will be a secondary endpoint of interest.

Secondary outcome [16]

Targeted and/or untargeted metabolomics (plasma)

Timepoint [16]

Given secondary outcomes are assessed at multiple timepoints, there is no primary timepoint. However, comparing any changes from baseline at 16 weeks post-commencement between groups will be a secondary endpoint of interest.

Eligibility

Key inclusion criteria

Voluntarily consenting Trainees undertaking Infantry Initial Employment Training (IET) at Lone Pine Barracks, Singleton, NSW and aged 18–39 years old.

Minimum age

18 Years

Maximum age

39 Years

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

The following exclusion criteria will apply to participation:

• A self-reported history of a diagnosed eating disorder
• Individuals younger than 18 years of age
• Diagnosed disease of the gastrointestinal tract including, but not limited to diverticulitis, inflammatory bowel disease, irritable bowel syndrome, peptic ulcer disease, Crohn's disease, ulcerative colitis, history of gastric bezoar, past gastrointestinal surgery and/or colonoscopy within 3 months of study participation
• Diagnosed metabolic or cardiovascular abnormalities (e.g., kidney disease, diabetes, cardiovascular disease, etc.)
• Any diagnosed food allergies or intolerances.
• Any use of antibiotics during Infantry IET, except topical antibiotics
• Anyone who is recommencing Infantry IET after having previously commenced at an earlier date (i.e. those who have been back squadded)

Study design

Statistical methods / analysis

In this study, we seek to detect any significant improvements in key physical fitness training outcomes (e.g. maximal strength and/or military task related muscular strength) in the Intervention Group vs. the Control Group. To our knowledge, a study with an intervention similar to ours (involving promoting performance nutrition behaviours by combining an education program with greater access to the right foods pre- and post training sessions)) has not concurrently measured physical fitness outcomes in a military setting to date. A repeated measures MANOVA analysis, allowing for multiple outcome measures (e.g. fat-free mass and performance in physical fitness assessments) with three assessments for all participants, was used to estimate the sample size required in this study. Effect sizes of = 0.41 for improvements in lean body mass and push up performance were found in a previous study (McAdam et al., 2018). Thus, using an effect size of 0.41, and assuming a significance level of 5% and power of 70%, the sample size for this study was determined to be 49. Therefore, we propose to seek participants from a total of four platoons of ~30–45 individuals, with participants sought from two platoons for each of the two study groups. Given participation in this study involves some benefits for participants in both the Intervention Group (during their IET) and the Control Group (at the end of their IET), we anticipate a participation rate of 60% of potential participants. This equates to 61–108 individuals who may volunteer participate in this study. Accounting for attrition of 20%, this equates to 49–84 participants completing the study.

The hypotheses that will be tested in this study are as follows:

1. Promoting performance nutrition behaviours through group education and providing greater access to performance enhancing (easy-to-digest) foods surrounding physical training sessions will lead to improved nutrition knowledge and higher overall dietary intake during the 16 weeks of Infantry IET training compared to usual nutrition advice and food/catering provisions.
2. Improved nutrition knowledge and higher overall energy and macronutrient intake and quality of trainees combined with improved fuelling pre- and post-training sessions will enhance training performance and recovery and therefore significantly improve training adaptations (e.g. body composition, in particular fat-free mass, and performance in physical fitness assessments) compared to trainees receiving usual nutrition advice and food/catering provisions
3. Improved performance nutrition knowledge, dietary intake and quality combined with pre- and post-training fuelling will reduce gastrointestinal symptoms, maintain blood sex hormone levels and/or markers of bone metabolism compared to trainees receiving usual nutrition advice and food/catering provisions.
4. Improved performance nutrition knowledge, dietary intake and quality combined with pre- and post-training fuelling will reduce musculoskeletal injury rates compared to trainees receiving usual nutrition advice and food/catering provisions.
5. Utilisation of Active musculoskeletal injury surveillance methods (self-reported) will identify a greater number of injuries and associated burden compared to other passive methods of injury monitoring used within the Australian Defence Force.

Descriptive statistical analysis will include calculation of sample means, standard deviation (SD) and proportions according to the type of variable. All baseline characteristics between platoons (clusters) and study groups will be compared using chi-squared and independent sample t-tests as appropriate. Where any significant differences in any variables are found across the clusters and groups, these variables will be adjusted for in subsequent analyses. Study hypotheses 1 to 4 will be addressed using a 3-level hierarchical linear model. The three levels are time, participant and cluster. Where there are significant group-X-time interactions, planned contrast will compare changes from baseline under each group. The analysis will allow the adjustment for any differences at baseline, for demographic characteristics, and any cluster characteristics.
Descriptive musculoskeletal injury data, such as counts and proportions with 95% confidence intervals, will be analysed for all data items collected from self-report surveys, physiotherapy consultations and Sentinel. For example, descriptive analysis from physiotherapy consultations will include, incidence of injuries associated with each training activity, as well as injury severity and training outcomes metrics, such as the total time loss for each platoon based on number of restricted duty days and the number of participants requiring delayed training due to injury. Subgroup analyses comparing injury incidence will consider a range of variables, such as age and sex. Descriptive musculoskeletal injury data variables will be presented in table format. If a small number of cases for a particular data item risk an individual being identified from the data e.g, sex, then suppression techniques will be used to protect privacy. Age will be recorded by actual age, as per the World Health Organization injury surveillance recommendations (Holder et al., 2001) and manipulated later by assigning an age group category of 5 year increments. Data will then be analysed and reported using these categories to protect anonymity of data collected.
To address study hypothesis 5 and compare musculoskeletal injury rates between the three surveillance methods that will be employed, Generalised Linear Modelling will be used, with Poisson or Negative Binomial Distributions due the nature of the count data being collected. Following assumption checks, count data will be analysed as incidence once an exposure offset is introduced. Robust errors may be utilised if assumptions are not met in Poisson modelling. The level of significance will be at a = 0.05, with Bonferroni adjustments for multiple comparisons. IBM® SPSS® Statistics version 28.0.1 will be used for all analyses.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

22/08/2023

Actual

22/08/2023

Date of last participant enrolment

Anticipated

25/03/2024

Actual

27/02/2024

Date of last data collection

Anticipated

31/07/2024

Actual

22/07/2024

Sample size

Target

49

Accrual to date

Final

149

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment postcode(s) [1]

2330 - Singleton

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Australian Government, Department of Defence, Defence Science and Technology Group

Country [1]

Australia

Funding source category [2]

Government body

Name [2]

Australian Defence Force, Joint Capabilities, Joint Health Command

Country [2]

Australia

Primary sponsor type

Government body

Name

Australian Government, Department of Defence, Defence Science and Technology Group

Country

Australia

Secondary sponsor category [1]

Individual

Name [1]

Prof Matthew Cooke

Country [1]

Australia

Secondary sponsor category [2]

University

Name [2]

La Trobe University

Country [2]

Australia

Secondary sponsor category [3]

Government body

Name [3]

Australian Government, Department of Defence, Defence People Group

Country [3]

Australia

Secondary sponsor category [4]

Government body

Name [4]

Australian Defence Force, Australian Army, Forces Command Headquarters

Country [4]

Australia

Secondary sponsor category [5]

Government body

Name [5]

Australian Defence Force, Joint Capabilities, Joint Health Command

Country [5]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Departments of Defence and Veterans' Affairs Human Research Ethics Committee (DDVA HREC)

Ethics committee address [1]

100 Northcott Dr, Campbell Park Offices, CP2-7-094, Canberra, ACT 2610

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

15/06/2023

Approval date [1]

09/08/2023

Ethics approval number [1]

Ethics committee name [2]

La Trobe University Human Research Ethics Committee

Ethics committee address [2]

Susan Cameron
La Trobe University
Plenty Road
Bundoora, Melbourne VIC 3086

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

17/07/2023

Approval date [2]

Ethics approval number [2]

Summary

Brief summary

Currently, the health impacts on Australian Army trainees undergoing Infantry Initial Employment Training are unknown. Subsequently, the Australian Army has little evidence to guide prevention strategies in this population. Focused research is required to investigate health outcomes during infantry training and trial interventions to mitigate preventable health problems. With this evidence, the Australian Army can inform future policy and improve practice to preserve and optimise the health of the force, such as increasing nutrition support to trainees. Proper and adequate nutrition is imperative to achieve the aim of every army; to transform civilians into fit, capable and resourceful members. A major gap in the research conducted to date is the paucity of studies that have concurrently measured dietary intakes and physical performance and health indicators to understand whether any shortfalls in dietary intakes lead to reductions in military-relevant health and performance indicators. Moreover, there is a lack of studies that have employed an intervention informed by behaviour change theory while translating eating strategies that are widely used in elite sport to army initial training with the aim of improving training outcomes (such as performance in physical fitness assessments and measures of body composition such as fat-free mass) and reducing the risk of musculoskeletal injury.

Thus, the primary aims of this study are to:

•	Determine the effectiveness of promoting performance nutrition behaviours (intervention) to significantly improve nutrition knowledge; increase dietary energy intakes; and/or enhance macronutrient intake ratios and/or diet quality during the 16 weeks of Infantry Initial Employment Training (IET) compared to usual practice (no intervention).

•	Determine the effectiveness of promoting performance nutrition behaviours (intervention) to significantly enhance body composition (in particular fat-free mass), physical fitness performance, blood markers of bone metabolism and sex hormones; and/or significantly reduce symptoms of gastrointestinal distress during the 16 weeks of Infantry Initial Employment Training (IET) compared to usual practice (no intervention).

•	Determine if increases in total energy and/or macronutrient intakes are associated with increases in: nutrition knowledge; fat-free mass; physical fitness assessment performance, blood markers of bone metabolism and sex hormones over the 16 weeks of Infantry IET.

The secondary aim of this project is:

•	Determine the effectiveness of promoting performance nutrition behaviours (intervention) to reduce rates of musculoskeletal injury over the 16 weeks of Infantry IET.

The exploratory aim of this project is:

•	Collect data from various musculoskeletal injury surveillance methods and systems in the ADF and compare injury estimates across methodologies.

Trial website

Public notes

Contacts

Principal investigator

Name

Prof Matthew Cooke

Address

La Trobe University
Plenty Road
Health Sciences Building 3, Room 213
Bundoora, Vic, 3086, Australia

Country

Australia

Phone

+61 3 94792484

Email

[email protected]

Contact person for public queries

Name

Matthew Cooke

Address

La Trobe University
Plenty Road
Health Sciences Building 3, Room 213
Bundoora, Vic, 3086, Australia

Country

Australia

Phone

+61 3 94792484

Email

[email protected]

Contact person for scientific queries

Name

Matthew Cooke

Address

La Trobe University
Plenty Road
Health Sciences Building 3, Room 213
Bundoora, Vic, 3086, Australia

Country

Australia

Phone

+61 3 94792484

Email

[email protected]

Trial Review

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