Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001105831
Ethics application status
Approved
Date submitted
1/07/2021
Date registered
20/08/2021
Date last updated
20/08/2021
Date data sharing statement initially provided
20/08/2021
Date results provided
20/08/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
A lifestyle health intervention in airline pilots during a global pandemic
Scientific title
The effects of a multicomponent lifestyle intervention for health behavior change and weight loss maintenance in airline pilots during a global pandemic: A controlled trial
Secondary ID [1] 304684 0
N/A
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 322663 0
Hypertension 322664 0
Physical inactivity 322665 0
Inadequate sleep 322666 0
Insufficient fruit and vegetable intake 322667 0
Condition category
Condition code
Diet and Nutrition 320274 320274 0 0
Obesity
Physical Medicine / Rehabilitation 320275 320275 0 0
Other physical medicine / rehabilitation
Public Health 320276 320276 0 0
Health promotion/education
Cardiovascular 320277 320277 0 0
Hypertension

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The overall intervention duration was 17-weeks. The intervention commenced with a one-hour individual face-to-face consultation session with an experienced health coach (with over 20 years’ experience) at the airline medical unit. In this initial consultation session, the pilots’ barriers, facilitators, and motivations to health behaviour change were assessed with validated methods, which were factored into the development of an individualised health programme. Further, personalised collaborative goal setting was carried out for the pilot with assistance from the health coach, establishing appropriate outcome, performance, and process goals 30 for (a) sleep hygiene, (b) healthy eating, and (c) physical activity.
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 study and the contents were derived from previous sleep hygiene and stimulus control studies. At the time of the initial consultation session, pilots completed the sleep hygiene checklist and Pittsburgh Sleep Quality Index (PSQI). Findings from these assessments were discussed between the health coach and participant, with suboptimal PSQI component scores and unachieved sleep hygiene strategies factored into collaborative establishment of sleep priorities. Thereafter, participants collaboratively set personalised sleep hygiene goals with support from the health coach. Examples of sleep hygiene strategies included implementation of regular sleep and wake times, perform and pre-bed relaxation routine, dim lights and avoid screen time within 30 minutes before bed etc.

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). At baseline participants completed a 24-hour dietary recall, of which findings were used to identify suboptimal dietary behaviours and healthy eating priorities. Relative to participant baseline behaviors, collaborative individualized goals were collaboratively established (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 perceived barriers, facilitators and motivations to 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, 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). Weekly emails and a mid-intervention phone call were utilised as reminders to participants to safely and feasibly increase their activity throughout the intervention.
A mid-intervention (week 8, approximately 10 minutes duration) phone call was conducted to support intervention adherence and monitor progress. The phone call consisted of a semi-structured interview focused on reviewing progress and compliance to individual goals for sleep hygiene, healthy eating, and physical activity established during the baseline consultation. Advice was provided where necessary, consistent with that which was provided at the pre-test.
Throughout the intervention, weekly health education posts were delivered to participants via email. 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. During lockdowns enacted due to the global pandemic, content was tailored to the pandemic conditions, including strategies for physical activity at home, healthy recipes, and immune system health information. 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.
Intervention code [1] 321057 0
Lifestyle
Intervention code [2] 321058 0
Behaviour
Intervention code [3] 321059 0
Prevention
Comparator / control treatment
The participants in the control group were blind to the intervention and received no intervention or instruction regarding health behaviors during the study timeframe. Control participants volunteered to participate by completing testing at the time of completing their routine aviation medical examinations.
Control group
Active

Outcomes
Primary outcome [1] 328131 0
Bodyweight was measured using SECA 813 electronic flat scales (SECA, Hamburg, Deutschland)
Timepoint [1] 328131 0
18 weeks and 54 weeks (primary endpoint) post-intervention commencement
Primary outcome [2] 328132 0
Blood pressure. Two blood pressure readings were measured with an OMRON HEM-757 device in a sitting position with arm supported held at the level of the atria.
Timepoint [2] 328132 0
18 weeks and 54 weeks (primary endpoint) post-intervention commencement
Secondary outcome [1] 397774 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 [1] 397774 0
18 weeks and 54 weeks post-intervention commencement
Secondary outcome [2] 397775 0
Exercise minutes per week measured by the International Physical Activity Questionnaire
Timepoint [2] 397775 0
18 weeks and 54 weeks post-intervention commencement
Secondary outcome [3] 397776 0
Sleep hours per night measured by the Pittsburgh Sleep Quality Index
Timepoint [3] 397776 0
18 weeks and 54 weeks post-intervention commencement

Eligibility
Key inclusion criteria
The study population consisted of commercial pilots from a large international airline. Inclusion criteria were (a) pilots with a valid commercial flying license, (b) working on a full-time basis, (c) having a body mass index (BMI) of over 25, and (d) a resting blood pressure of greater than 120/80 (systolic/diastolic).
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
(a) pilots not having a valid commercial flying license, (b) not working on a full-time basis, (c) having a body mass index (BMI) of < 25, and (d) a resting blood pressure of <120/80 (systolic/diastolic).

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Raw data are extracted from the Qualtrics online survey software (Qualtrics, Provo, UT, USA), entered into an Excel spreadsheet (Microsoft, Seattle, WA, USA) and then imported into the Statistical Package for the Social Sciences (SPSS, version 27; IBM, New York, NY, USA) for all statistical analyses. All variables are 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 is used to test homogeneity of variance. Listwise deletion is 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 is utilized test for group x time interactions, time effects (baseline to week 18 and week 52), and group effects. Where significant, Bonferroni post-hoc analyses are incorporated to determine significant changes from baseline to week 18 and week 52. Age, sex and flights are included as covariates in the ANOVA. T-tests are utilized to explore the magnitude of differences between groups. Effect sizes were calculated using Cohen’s d to quantify between group effects from pre-testing to post-testing. Effect sizes thresholds is set at >1.2, >0.6, >0.2, <0.2 were classified as large, moderate, small, and trivial 51. The alpha level is set at p < 0.05.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
17/02/2020
Date of last participant enrolment
Anticipated
Actual
1/03/2020
Date of last data collection
Anticipated
Actual
31/03/2021
Sample size
Target
72
Accrual to date
Final
72
Recruitment outside Australia
Country [1] 23938 0
New Zealand
State/province [1] 23938 0
Auckland

Funding & Sponsors
Funding source category [1] 309053 0
University
Name [1] 309053 0
University of Waikato
Country [1] 309053 0
New Zealand
Primary sponsor type
University
Name
Daniel Wilson
Address
University of Waikato, 52 Miro Street, Mount Maunganui, Tauranga 3116
Country
New Zealand
Secondary sponsor category [1] 309996 0
None
Name [1] 309996 0
Address [1] 309996 0
Country [1] 309996 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308928 0
Human Research Ethics Committee of the University of Waikato in New Zealand
Ethics committee address [1] 308928 0
Ethics committee country [1] 308928 0
New Zealand
Date submitted for ethics approval [1] 308928 0
Approval date [1] 308928 0
26/01/2020
Ethics approval number [1] 308928 0
2020#07

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

Contacts
Principal investigator
Name 112374 0
Dr Daniel Wilson
Address 112374 0
Toi Ohomai Institute of Technology, 70 Windermere Drive, Poike, Tauranga 3112
Country 112374 0
New Zealand
Phone 112374 0
+64 279241138
Fax 112374 0
Email 112374 0
[email protected]
Contact person for public queries
Name 112375 0
Daniel Wilson
Address 112375 0
Toi Ohomai Institute of Technology, 70 Windermere Drive, Poike, Tauranga 3112
Country 112375 0
New Zealand
Phone 112375 0
+64 279241138
Fax 112375 0
Email 112375 0
[email protected]
Contact person for scientific queries
Name 112376 0
Daniel Wilson
Address 112376 0
Toi Ohomai Institute of Technology, 70 Windermere Drive, Poike, Tauranga 3112
Country 112376 0
New Zealand
Phone 112376 0
+64 279241138
Fax 112376 0
Email 112376 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
No additional documents have been identified.