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Trial registered on ANZCTR


Registration number
ACTRN12616000350426
Ethics application status
Approved
Date submitted
8/03/2016
Date registered
18/03/2016
Date last updated
24/03/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
‘HEYMAN’: Harnessing Ehealth to enhance Your Mental health, Activity and Nutrition in young adult men.
Scientific title
Feasibility and preliminary efficacy of a targeted multi-component healthy lifestyle intervention for young men.
Secondary ID [1] 288434 0
Nil
Universal Trial Number (UTN)
Trial acronym
HEYMAN
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Overweight and obesity 297453 0
Stress 297454 0
Condition category
Condition code
Diet and Nutrition 297645 297645 0 0
Obesity
Mental Health 297646 297646 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
HEYMAN is a 3-month intervention. The goal of HEYMAN is to improve key lifestyle behaviours including physical inactivity, poor eating habits, alcohol use and to facilitate with stress management. The intervention components have been developed based on previous formative research (focus groups n=61 and online survey n=282) with young men. To assist young men to implement the desired changes to behaviour, Participants will be asked to engage with the following ehealth and face-to-face intervention components:

1) Password protected access to the HEYMAN website (www.heymanprogram.com). The website includes information and resources for improving eating habits, increasing physical activity levels, improving muscle mass, reducing sugary drinks and alcohol and strategies for coping with stress.
2) A wearable device fitness band (JAWBONE UP24) to be worn 24 hours per day for the duration of the trial and associated fitness tracker app which will assist in goal setting and self-monitoring physical activity, weight, diet, sleep and mood.
3) Weekly (1 hour) face-to-face sessions covering exercise, stress and healthy eating. The sessions will be ran by two male PhD candidates; one is a qualified P.E teacher undertaking a PhD in education and the other is undertaking a PhD in Nutrition and Dietetics. There will be 11 group based sessions and 1 individualized (one-to-one) which will occur in week three.
4) Private Facebook group to facilitate with social support
5) Participants will be provided with a gymstick 'Registered Trademark' resistance band to allow home-based strength training (with associated routines available on the website) a template dinner disc and lunch box to help you control the portion size of foods.
6) Receive feedback from Australian Eating Survey: participants will complete a self-reported survey on their eating habits. A feedback report will then be generated which compares usual dietary intake to Australian dietary recommendations, The report will highlight diet variety and the contribution of specific food groups to average daily energy intake. It details how much of daily energy intake usually comes from healthy food groups compared to the amount coming from discretionary choices. The report will then be discussed in the individualized session in week 3 and tailored goals with be set following this.

The following strategies will be used to monitor adherence: 1) use of IFTTT software (https://ifttt.com/) to access Jawbone fitness tracker data. 2) Number of posts to the Facebook support group. 3) A google analytics plug in will be incorporated into website to assess web-site usage and 4) participants will sign in at the start of the face-to-face sessions to confirm attendance.
Intervention code [1] 293755 0
Behaviour
Intervention code [2] 293756 0
Lifestyle
Intervention code [3] 293757 0
Prevention
Comparator / control treatment
Waiting list control group (will receive access to HEYMAN after 3-months)
Control group
Active

Outcomes
Primary outcome [1] 297183 0
Physical activity: (step counts) will be objectively measured using pedometers (Yamax DigiWalker SW700). As this is a feasibility study this outcome is to determine preliminary efficacy
Timepoint [1] 297183 0
Change from baseline to post-intervention (3-months).
Primary outcome [2] 297692 0
Dietary intake (diet quality) will be assessed using a validated Food Frequency Questionnaire (Australian Eating Survey). As this is a feasibility study this outcome is to determine preliminary efficacy
Timepoint [2] 297692 0
Change from baseline to post-intervention (3-months)
Primary outcome [3] 297693 0
Quality of life: measured using Satisfaction with Life questionnaire (5 item). As this is a feasibility study this outcome is to determine preliminary efficacy
Timepoint [3] 297693 0
Change from baseline to post-intervention (3-months)
Secondary outcome [1] 320265 0
Program acceptability will be evaluated using a process evaluation questionnaire (intervention group only) that was designed by the researchers for the study. (Primary outcome)
Timepoint [1] 320265 0
Post intervention (3-months)
Secondary outcome [2] 320266 0
Intervention participants usage of the intervention (e.g. website visits, attendance at face-to-face sessions, use of fitness tracker) will be objectively tracked by the program. (Primary outcome)
Timepoint [2] 320266 0
Throughout intervention (from baseline to 3-months)
Secondary outcome [3] 320267 0
Body Composition (fat mass and muscle mass): Measured by: InBody 720 analyser.
Timepoint [3] 320267 0
Change from baseline to post-intervention (3-months)
Secondary outcome [4] 320268 0
Body mass index: Height will be measured using a stadiometer (Inbody BSM 370), and BMI will be calculated from measured height and weight using the standard equation
Timepoint [4] 320268 0
Change from baseline to post-intervention (3-months)
Secondary outcome [5] 320269 0
Systolic blood pressure, diastolic blood pressure (composite measures) will be measured using an automatic sphygmomanometer (PULSECOR)
Timepoint [5] 320269 0
Change from baseline to post intervention (3-months)
Secondary outcome [6] 320270 0
Total cholesterol, HDL-Cholesterol, LDL-Cholesterol and Triglycerides (composite measures) will be measured via a finger prick blood sample which will be analysed using the Cardiochek.
Timepoint [6] 320270 0
Change from baseline to post-intervention (3-months)
Secondary outcome [7] 321583 0
Waist Circumference will be measured to 0.1 cm using a non-extensible steel tape, with waist measured at the narrowest point between the lower costal border and the umbilicus
Timepoint [7] 321583 0
Change from baseline to post-intervention (3-months)
Secondary outcome [8] 321865 0
Physical activity: MVPA will be assessed using the self-reported Godin Leisure Time Exercise Questionnaire
Timepoint [8] 321865 0
Change from baseline to post-intervention (3-months)
Secondary outcome [9] 321867 0
Pulse rate and arterial stiffness augementation index (Composite measures)will be measured using an automatic sphygmomanometer (PULSECOR)
Timepoint [9] 321867 0
Change from Baseline to post-intervention (3-months)
Secondary outcome [10] 321868 0
Weight will be objectively measured on a digital scale (Inbody 720).
Timepoint [10] 321868 0
Change from baseline to post-intervention (3-months)
Secondary outcome [11] 321869 0
Biomarker for stress (salivary Cortisol) measured using the passive drool technique.
Timepoint [11] 321869 0
Change from baseline to post-intervention (3-months)
Secondary outcome [12] 321870 0
Psychological distress will be measured using the Kessler Psychological Distress scale (K-10)
Timepoint [12] 321870 0
Change from baseline to post-intervention (3-months)
Secondary outcome [13] 321871 0
Well-being will be measured using the ‘Mental Health Continuum -Short form’ (MHC-SF)
Timepoint [13] 321871 0
Change from baseline to post-intervention (3-months)
Secondary outcome [14] 321873 0
Dietary intake: Skin reflectance which is a biomarker of skin carotenoids which may reflect fruit and vegetable intake measured using a handheld spectrophotometer. Measurement sites include palm, inner arm and outer arm
Timepoint [14] 321873 0
Change from baseline to post-intervention (3-months)
Secondary outcome [15] 321957 0
Dietary intake (energy, macro/micronutrient and food group intake) will be assessed using a validated Food Frequency Questionnaire (Australian Eating Survey).
Timepoint [15] 321957 0
Change from baseline to post-intervention (3-months)
Secondary outcome [16] 321958 0
Feasibility (e.g. effectiveness of different recruitment strategies, % retained and intervention fidelity) will be objectively tracked by the program
Timepoint [16] 321958 0
Throughout the program (from baseline to 3-months)
Secondary outcome [17] 321959 0
Depression, Anxiety & stress will be measured using the Depression Anxiety Stress scale (DASS-21)
Timepoint [17] 321959 0
Change from baseline to post-intervention (3-months)
Secondary outcome [18] 321960 0
Quality of life: will be measured using the Quality of Life, Enjoyment & Satisfaction (14 item)
Timepoint [18] 321960 0
Change from baseline to post-intervention (3-months)
Secondary outcome [19] 321961 0
Alcohol use: measured by Alcohol Use Disorders Identification Test–consumption scale (AUDIT-c)
Timepoint [19] 321961 0
Change from baseline to post-intervention (3-months)

Eligibility
Key inclusion criteria
Male
Aged 18-25 years.
Able to attend the University of Newcastle for two assessment sessions
Agree not to participate in other health programs during this study
Access to a computer, tablet (e.g. Ipad) or smartphone with email and internet facilities
Minimum age
18 Years
Maximum age
25 Years
Gender
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
-Currently meeting national recommendations for fruit and vegetables intakes (men aged 18 years: greater than or equal to 5 Vegetables & 2 fruit daily, men aged 19-25 years: greater than or equal to 6 Vegetables & 2 fruit daily)
-Currently meeting national physical activity recommendations (moderate-intensity PA for 300 minutes or more per week or vigorous-intensity PA for 150 minutes or more per week or combined moderate and vigorous physical activity (MVPA) of 300 minutes or more per week)
-History of major medical problems such as heart disease or diabetes that requires insulin injections and do not have approval from your GP to participate in the program
-Suspected to have a severe mental disorder and do not have approval from GP (or associated expert) clearance to participate in the program.
-Have a disability (eg physical / mobility disability, sight or hearing impairment)
-Have a diagnosis of an eating disorder (e.g. anorexia nervosa or bulimia)
-Non- English speaking

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)
Sequentially numbered opaque sealed envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer random number generator
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Analyses will be performed using Stata Version 12. All variables will be checked for plausibility and missing values. Data will be presented as mean (sd) for continuous variables and counts (percentages) for categorical variables. Differences in pre- and post-test values will be tested using dependent t-test for continuous variables and chi squared (x2) tests for categorical variables. A value of p = 0.05 was considered statistically significant.

Given that this is a feasibility study the outcome effects will be investigated using effect sizes, which will inform future sample size calculations for larger trials. Recent guidelines for developing and reporting feasibility studies (Lancaster 2015 - www.mrc.ac.uk/complexinterventionsguidance) reports a key objective of a feasibility study is to gain initial estimates for sample size calculation. A recent review on pilot and feasibility RCT''s (Shanyinde et al 2011) identified a median sample size of 31 in non-drug trials, therefore we identified a target of 50 participants to exceed this number.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 292780 0
Other
Name [1] 292780 0
3D Healing Walk grant provided by Hunter Medical Research Institute (HMRI)
Address [1] 292780 0
1 Kookaburra Circuit, New Lambton Heights NSW 2305
Country [1] 292780 0
Australia
Primary sponsor type
Individual
Name
Prof Clare Collins
Address
University Of Newcastle, School of Health Sciences, Hunter Building (HA12), University Drive, Callaghan, NSW 2308
Country
Australia
Secondary sponsor category [1] 291516 0
University
Name [1] 291516 0
University of Newcastle
Address [1] 291516 0
University drive, Callaghan, NSW, Australia, 2308
Country [1] 291516 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294274 0
University of Newcastle Human Research Ethics Committee
Ethics committee address [1] 294274 0
University Drive, Callaghan, NSW 2308
Ethics committee country [1] 294274 0
Australia
Date submitted for ethics approval [1] 294274 0
25/11/2015
Approval date [1] 294274 0
07/03/2016
Ethics approval number [1] 294274 0
H-2015-0445

Summary
Brief summary
The aim of the research is to evaluate the feasibility and preliminary efficacy of a 3-month healthy lifestyle program (HEYMAN) for young men (aged 18-25 years) delivered using ehealth and weekly face-to-face sessions. HEYMAN is developed based on previous formative research with young men

Participants will be randomly allocated to the intervention (HEYMAN) or waiting list control group. After 3-months the waiting list control group will receive access to hEYMAN program tools.

Participants in both groups will be asked to have a series of measures taken (e.g. weight, height) and complete online questionnaires at the start of the program (baseline) and post program (3-months). The researchers will also track intervention participants engagement with the program (e.g. session attendance, website use metrics), retention, acceptability and satisfaction with the program.
Trial website
Trial related presentations / publications
Ashton LM, Morgan PJ, Hutchesson MJ, Rollo ME and Collins CE. (2017) Feasibility and preliminary efficacy of the ‘HEYMAN’ healthy lifestyle program for young men: a pilot randomised controlled trial. Nutrition Journal. 16(2). DOI 10.1186/s12937-017-0227-8
Public notes

Contacts
Principal investigator
Name 63134 0
Prof Clare Collins
Address 63134 0
School of Health Sciences, Hunter Building (HA12), University Drive, The University of Newcastle, Callaghan, NSW 2308
Country 63134 0
Australia
Phone 63134 0
+61 2 4921 5646
Fax 63134 0
Email 63134 0
clare.collins@newcastle.edu.au
Contact person for public queries
Name 63135 0
Prof Clare Collins
Address 63135 0
School of Health Sciences, Hunter Building (HA12), University Drive, The University of Newcastle, Callaghan, NSW 2308
Country 63135 0
Australia
Phone 63135 0
+61 2 4921 5646
Fax 63135 0
Email 63135 0
clare.collins@newcastle.edu.au
Contact person for scientific queries
Name 63136 0
Prof Clare Collins
Address 63136 0
School of Health Sciences, Hunter Building (HA12), University Drive, The University of Newcastle, Callaghan, NSW 2308
Country 63136 0
Australia
Phone 63136 0
+61 2 49215646
Fax 63136 0
Email 63136 0
clare.collins@newcastle.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary