Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000288729
Ethics application status
Approved
Date submitted
9/02/2022
Date registered
15/02/2022
Date last updated
15/02/2022
Date data sharing statement initially provided
15/02/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
The effects of an app-based health and fitness intervention for airline pilots
Scientific title
The effects of an app-based multi-component lifestyle intervention on health and fitness in airline pilots: A randomized controlled trial.
Secondary ID [1] 306384 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 325212 0
Physical inactivity 325244 0
Condition category
Condition code
Diet and Nutrition 322610 322610 0 0
Obesity
Cardiovascular 322611 322611 0 0
Normal development and function of the cardiovascular system
Mental Health 322612 322612 0 0
Studies of normal psychology, cognitive function and behaviour
Public Health 322613 322613 0 0
Health promotion/education
Musculoskeletal 322614 322614 0 0
Normal musculoskeletal and cartilage development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is an app-based 16-week lifestyle program that incorporates evidence-based strategies for improving physical activity, nutrition and sleep. The program is administered through an app platform. The program will be conducted once, with all participants engaging simultaneously. Being app-based, the participants can access the program from their place of residence and will not make face-to-face contact with the researchers.
Each participant is granted access to the app, which contains all intervention supplied material including a calendar loaded with physical activity session plans, health educational materials, and weekly health behavior self-monitoring questionnaires.
Prior to the commencement of the intervention, volunteers will be randomized to either an intervention group, or a wait-list control.
The intervention commences with participants completing an online health survey (evaluating subjective health outcome measures, a physical activity pre-screen, and individual goals and preferences) and a range of self-administered physical assessments (physical fitness outcome measures). For physical assessments (such as push-ups and plank hold) educational materials are provided to participants that demonstrate correct technique to perform the activity. Subsequently, an experienced health coach (with over 20 years’ experience) remotely allocates a personalized programme to each participant according to their goals and preferences.
Sleep hygiene represents a range of behavioural and environmental practices which support restorative sleep. An evidence-based sleep hygiene checklist was developed specifically for this intervention and the contents were derived from previous sleep hygiene and stimulus control studies. Educational materials pertaining to healthy sleep habits (such as regular sleep and wake times, perform and pre-bed relaxation routine, dim lights and avoid screen time within 30 minutes before bed etc.) are provided to participants via readings within the app during the intervention, and participants self-monitor hours of sleep per night weekly.
Evidence-based healthy dietary behaviours which support a healthy bodyweight were delivered through individualized advice and educational materials. Healthy eating principles included limiting processed foods and enhancing whole food consumption, “adding colour” via consumption of fruit and vegetables and choosing nutrient dense foods, and reducing white carbohydrates, refined carbohydrates and added sugar (for example, energy dense food). Weekly educational materials, along with prompts to action are promoted to participants during the intervention (for example; adding colourful whole foods to meals; replace high glycaemic index (GI) foods with low GI options; replace processed breakfast cereal with egg and vegetable omelette). Prescribed dose of fruit was equal to or greater than 2 servings and vegetables was equal to or greater than 3 serves per day.
Congruent with the participant’s preferences and goals towards exercise, personalized physical activity prescription was established with the application of the frequency, intensity, time, and type (FITT) principles, and progression to attainment of sufficient moderate-to-vigorous physical activity (MVPA) to meet guidelines appropriate to individual capabilities. A minimum dose of weekly MVPA at commencement of the intervention was 150 minutes per week, such as 3x50 minute activity sessions or 5x30 minute activity sessions. Frequency and time of PA sessions were tailored to participant weekly time availability. Intensity was tailored based on participant physical activity experience, physical fitness, and goal orientation. Type of PA was customized to the individual’s modality preferences for cardiovascular (such as walking, running, or cycling) and strengthening (for example, resistance equipment and/or bodyweight exercises) PA. Physical activity progression self-monitoring was indicated via weekly session completion tracking within the app, and participants were advised to implement small progressive changes in PA during the intervention (such as; increase session duration; perform more repetitions; perform greater intensity; or accomplish more weekly bouts).
Throughout the intervention, weekly health education posts were delivered to participants via the app. The emails consisted of educational blog posts of varying topics related to sleep health, healthy nutrition, physical activity, and supporting a healthy immune system, congruent with evidence-based methods previously described. Educational content was derived from health authorities via publicly available information from the World Health Organization and the Centers for Disease Control and Prevention.
Intervention adherence was monitored via weekly logging of daily fruit and vegetable intake, average hours of sleep per night and weekly moderate to vigorous exercise session frequency and duration recording.
Participants are not expected to use the app for a minimum time duration each day, app engagement will be at the user’s discretion for reading exercise session outlines and educational materials. The anticipated time needed from participants to enter self-monitoring data per week is <5 minutes.
Intervention code [1] 322818 0
Prevention
Intervention code [2] 322819 0
Lifestyle
Intervention code [3] 322820 0
Behaviour
Comparator / control treatment
The control group will not engage in the lifestyle intervention, but the program will be made available free-of-charge to participants in the control group after the completion of the study (ie. after the 16-week post-intervention follow-up).
Control group
Active

Outcomes
Primary outcome [1] 330405 0
Body mass index will be measured via participant self-reported estimation of height in centimeters or metres and current body mass in kilograms or pounds
Timepoint [1] 330405 0
Baseline (week 0) and post intervention study completion (week 16)
Primary outcome [2] 330406 0
The physical health summary scale score and the mental health summary scale score derived from the 36-Item Short Form Survey (SF-36)
Timepoint [2] 330406 0
Baseline (week 0) and post intervention study completion (week 16)
Secondary outcome [1] 406127 0
Total distance covered in metres will be evaluated by the validated six-minute walk test
Timepoint [1] 406127 0
Baseline (week 0) and post intervention study completion (week 16)
Secondary outcome [2] 406128 0
Maximum repetitions of full range of motion push-ups using standardized technique (hand release at the bottom)
Timepoint [2] 406128 0
Baseline (week 0) and post intervention study completion (week 16)
Secondary outcome [3] 406129 0
Time in seconds using a digital stopwatch will be measured for the maximum duration plank isometric hold using standardized technique
Timepoint [3] 406129 0
Baseline (week 0) and post intervention study completion (week 16)
Secondary outcome [4] 406130 0
Fruit and vegetable intake (composite outcome). Fruit and vegetable intake were measured using two questions with acceptable validity and reliability derived from the New Zealand Health Survey. The questions asked participants to report on average, over the last week how many servings of fruit and vegetables they eat per day. Responses to these questions were combined to determine total daily fruit and vegetable intake.
Timepoint [4] 406130 0
Baseline (week 0) and post intervention study completion (week 16)
Secondary outcome [5] 406131 0
Exercise minutes per week measured by the International Physical Activity Questionnaire
Timepoint [5] 406131 0
Baseline (week 0) and post intervention study completion (week 16)
Secondary outcome [6] 406132 0
Sleep hours per night measured by the Pittsburgh Sleep Quality Index
Timepoint [6] 406132 0
Baseline (week 0) and post intervention study completion (week 16)

Eligibility
Key inclusion criteria
The study population will consist of commercial flight crew from a large international airline. Inclusion criteria are (1) flight crew, (2) working on a full-time basis, (3) having a body mass index (BMI) of over 25, (4) a resting blood pressure of greater than 120/80 (systolic/diastolic), (5) 18 years or over, (6) personal smartphone or tablet access, (7) fluent in English, (8) acceptance to provide informed consent, and (9) permission given for anonymous data to be used for research
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Inability to participate in moderate-intensity physical activity such as walking.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Raw data will be extracted from the Qualtrics online survey software (Qualtrics, Provo, UT, USA) and entered into an Excel spreadsheet (Microsoft, Seattle, WA, USA) and then imported into the Statistical Package for the Social Sciences (SPSS, version 28; IBM, New York, NY, USA) for all statistical analyses. All variables will be assessed using the Shapiro-Wilk’s test (p > 0.05) and its histograms, Q-Q plots and box plots for inspection for data normality. Levene’s test will be used to test homogeneity of variance. Listwise deletion will be applied for individual datasets with missing values or participants who did not complete post-testing.
Repeated-measures analysis of variance (ANOVA) using the General Linear Modelling function in SPSS will be utilized to test for group x time interactions, time effects (baseline to 16-weeks), and group effects. Age, sex and flights will be included as covariates in the ANOVA. T-tests will be utilized to explore the magnitude of differences between groups. Effect sizes will be calculated using Cohen’s d to quantify between group effects from pre-testing to post-testing. Effect sizes thresholds set at >1.2, >0.6, >0.2, <0.2 will be classified as large, moderate, small, and trivial. The alpha level is set at p < 0.05.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/03/2022
Actual
Date of last participant enrolment
Anticipated
1/04/2022
Actual
Date of last data collection
Anticipated
29/07/2022
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment outside Australia
Country [1] 24561 0
New Zealand
State/province [1] 24561 0

Funding & Sponsors
Funding source category [1] 310738 0
University
Name [1] 310738 0
University of Waikato
Country [1] 310738 0
New Zealand
Primary sponsor type
University
Name
University of Waikato
Address
University of Waikato, 52 Miro Street, Mount Maunganui, Tauranga 3116
Country
New Zealand
Secondary sponsor category [1] 311964 0
None
Name [1] 311964 0
Address [1] 311964 0
Country [1] 311964 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310314 0
Human Research Ethics Committee of the University of Waikato in New Zealand
Ethics committee address [1] 310314 0
Ethics committee country [1] 310314 0
New Zealand
Date submitted for ethics approval [1] 310314 0
01/01/2020
Approval date [1] 310314 0
26/01/2020
Ethics approval number [1] 310314 0
2020#07

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 117218 0
Dr Daniel Wilson
Address 117218 0
Toi Ohomai Institute of Technology, 70 Windermere Drive, Poike, Tauranga 3112
Country 117218 0
New Zealand
Phone 117218 0
+64 279241138
Fax 117218 0
Email 117218 0
[email protected]
Contact person for public queries
Name 117219 0
Daniel Wilson
Address 117219 0
Toi Ohomai Institute of Technology, 70 Windermere Drive, Poike, Tauranga 3112
Country 117219 0
New Zealand
Phone 117219 0
+64 279241138
Fax 117219 0
Email 117219 0
[email protected]
Contact person for scientific queries
Name 117220 0
Daniel Wilson
Address 117220 0
Toi Ohomai Institute of Technology, 70 Windermere Drive, Poike, Tauranga 3112
Country 117220 0
New Zealand
Phone 117220 0
+64 279241138
Fax 117220 0
Email 117220 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Individual data privacy outlined in participant informed consent


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseA Contactless App-Based Intervention to Improve Health Behaviors in Airline Pilots: A Randomized Trial.2023https://dx.doi.org/10.1016/j.amepre.2022.12.011
N.B. These documents automatically identified may not have been verified by the study sponsor.