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Trial registered on ANZCTR
Registration number
ACTRN12622000233729
Ethics application status
Approved
Date submitted
7/02/2022
Date registered
9/02/2022
Date last updated
9/02/2022
Date data sharing statement initially provided
9/02/2022
Date results provided
9/02/2022
Type of registration
Retrospectively registered
Titles & IDs
Public title
A lifestyle intervention in airline pilots to enhance health and fitness
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Scientific title
The effectiveness of a combined healthy eating, exercise, and sleep hygiene lifestyle intervention on health and fitness of airline pilots: A controlled trial.
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Secondary ID [1]
306370
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None
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Obesity
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Hypertension
325175
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Physical inactivity
325176
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Inadequate sleep
325177
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Insufficient fruit and vegetable intake
325179
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Condition category
Condition code
Diet and Nutrition
322578
322578
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0
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Obesity
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Public Health
322579
322579
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0
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Health promotion/education
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Cardiovascular
322596
322596
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0
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Hypertension
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
The overall intervention duration was 4 months. 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.
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Intervention code [1]
322797
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Lifestyle
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Intervention code [2]
322798
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Prevention
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Intervention code [3]
322799
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Behaviour
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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.
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Control group
Active
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Outcomes
Primary outcome [1]
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Cardiorespiratory Fitness was measured using a valid and reliable protocol on a WattBike, producing a value for VO2 max
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Assessment method [1]
330379
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Timepoint [1]
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4 months post intervention completion (endpoint)
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Primary outcome [2]
330380
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Body fat percentage was measured via skin fold calliper assessment, which was performed by a registered International Society for the Advancement of Kinanthropometry (ISAK) certified researcher and analysed congruent with ISAK methodology
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Assessment method [2]
330380
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Timepoint [2]
330380
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4 months post intervention completion (endpoint)
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Secondary outcome [1]
406017
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Bodyweight was measured using SECA 813 electronic flat scales (SECA, Hamburg, Deutschland)
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Assessment method [1]
406017
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Timepoint [1]
406017
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4 months post intervention completion (endpoint)
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Secondary outcome [2]
406018
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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.
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Assessment method [2]
406018
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Timepoint [2]
406018
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4 months post intervention completion (endpoint)
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Secondary outcome [3]
406019
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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.
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Assessment method [3]
406019
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Timepoint [3]
406019
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4 months post intervention completion (endpoint)
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Secondary outcome [4]
406020
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Exercise minutes per week measured by the International Physical Activity Questionnaire
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Assessment method [4]
406020
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Timepoint [4]
406020
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4 months post intervention completion (endpoint)
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Secondary outcome [5]
406021
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Sleep hours per night measured by the Pittsburgh Sleep Quality Index
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Assessment method [5]
406021
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Timepoint [5]
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4 months post intervention completion (endpoint)
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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).
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Minimum age
18
Years
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Maximum age
65
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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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).
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
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Masking / blinding
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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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 28; 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 4-months), and group effects. 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.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
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Actual
4/01/2021
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Date of last participant enrolment
Anticipated
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Actual
28/03/2021
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Date of last data collection
Anticipated
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Actual
31/07/2021
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Sample size
Target
79
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Accrual to date
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Final
121
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Recruitment outside Australia
Country [1]
24557
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New Zealand
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State/province [1]
24557
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Auckland
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Funding & Sponsors
Funding source category [1]
310723
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University
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Name [1]
310723
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University of Waikato
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Address [1]
310723
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University of Waikato, 52 Miro Street, Mount Maunganui, Tauranga 3116
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Country [1]
310723
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New Zealand
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Primary sponsor type
University
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Name
University of Waikato
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Address
University of Waikato, 52 Miro Street, Mount Maunganui, Tauranga 3116
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Country
New Zealand
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Secondary sponsor category [1]
311946
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None
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Name [1]
311946
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N/A
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Address [1]
311946
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N/A
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Country [1]
311946
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
310300
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Human Research Ethics Committee of the University of Waikato in New Zealand
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Ethics committee address [1]
310300
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Private Bag 3105 Hamilton 3240 New Zealand
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Ethics committee country [1]
310300
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New Zealand
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Date submitted for ethics approval [1]
310300
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01/01/2020
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Approval date [1]
310300
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26/01/2020
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Ethics approval number [1]
310300
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2020#07
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Summary
Brief summary
Purpose: The aim of this study was to determine whether a 4-month three-component lifestyle intervention is effective in improving fitness and achieving health behavior change in overweight and obese airline pilots. Methods: A parallel-group (intervention and control) study was conducted amongst 121 airline pilots over a 4-month period. The intervention group received a personalised sleep, dietary and physical activity programme over the 4-month period. The control group received no intervention. Outcome measures for sleep, fruit and vegetable intake, physical activity, and subjective health and objective measures fitness, body fat percentage, bodyweight, blood pressure and resting pulse were measured at baseline and 4-months (post intervention). The changes in outcome measures were used to determine the efficacy of the intervention.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Daniel Wilson
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Address
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Toi Ohomai Institute of Technology, 70 Windermere Drive, Poike, Tauranga 3112
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Country
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New Zealand
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Phone
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+64 279241138
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Daniel Wilson
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Address
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Toi Ohomai Institute of Technology, 70 Windermere Drive, Poike, Tauranga 3112
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Country
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New Zealand
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Phone
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+64 279241138
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Fax
117175
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Email
117175
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[email protected]
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Contact person for scientific queries
Name
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Daniel Wilson
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Address
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Toi Ohomai Institute of Technology, 70 Windermere Drive, Poike, Tauranga 3112
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Country
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New Zealand
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Phone
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+64 279241138
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Fax
117176
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Email
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
Individual data privacy outlined in participant informed consent
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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
Source
Title
Year of Publication
DOI
Embase
The Effectiveness of a Combined Healthy Eating, Physical Activity, and Sleep Hygiene Lifestyle Intervention on Health and Fitness of Overweight Airline Pilots: A Controlled Trial.
2022
https://dx.doi.org/10.3390/nu14091988
N.B. These documents automatically identified may not have been verified by the study sponsor.
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