Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000137493
Ethics application status
Approved
Date submitted
27/01/2016
Date registered
5/02/2016
Date last updated
26/07/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of the Rugby Fans in Training (RuFIT) study, a healthy lifestyle programme run through professional New Zealand rugby clubs, on bodyweight in men aged 25-65 years.
Scientific title
Rugby Fans in Training (RuFIT) feasibility study: a two-arm, multicentre, randomised control study to investigate the effects of a healthy lifestyle programme delivered through professional New Zealand rugby clubs on bodyweight in overweight men aged 25-65 years.
Secondary ID [1] 288422 0
None
Universal Trial Number (UTN)
U1111-1178-9454
Trial acronym
RuFIT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Overweight 297438 0
Condition category
Condition code
Diet and Nutrition 297624 297624 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study will investigate the feasibility of implementing the RuFIT programme in overweight New Zealand males. RuFIT has been modified from the Scottish Football Fans in Training (FFIT) programme, and is a healthy lifestyle programme delivered through professional rugby clubs and designed to help men make healthier lifestyle choices to reduce their bodyweight and improve their health. The 12-week intervention consists of twice weekly sessions which will be run at the rugby club (The Blues in Auckland and the Highlanders in Otago). Participants will receive training and fitness advice from the club trainers, in addition to education sessions on goal setting, lifestyle medicine, nutrition, physical activity, sleep, sedentary behaviour, and long-term maintenance of sustaining a healthier lifestyle. Participants will attend two 75-mintue sessions per week (one during the weekend and one during the working week). The weekend session will consist of an education session followed by a physical activity session, while the session during the working week will consist of a physical activity session only.

The education sessions will be run in an informal setting, where the participants will sit in a circle and have the opportunity to discuss the content of the presentation as a group. At the end of each education session, participants will make a goal that is relevant to the content that was delivered during the session. All the education sessions will be run by either the club trainer, club doctor, or club nutritionist, except three nutrition sessions which will be run by a community nutrition group (e.g. Pacific Heartbeat).

The physical activity program will be designed to progressively increase in difficulty over 12 weeks. The first 4 weeks will predominantly consist of aerobic off-feet conditioning (rower and bike) and body weight exercises (squats, push ups, body weight rows, lunges and core work). The second 4 weeks will consist of the same exercises as above but will also introduce external loads (e.g. Kettle bells, Dumbbells, barbells etc.) Running volume will also increased. The last 4 weeks will combine all of the above and involve strength, aerobic, and anaerobic conditioning. In addition, there will also be a number of small-sided games sessions.

All participants will also receive a pedometer to monitor their step count. Roll calls will be taken at the beginning of each session to assess adherence to the programme.
Intervention code [1] 293737 0
Lifestyle
Intervention code [2] 293738 0
Behaviour
Intervention code [3] 293830 0
Treatment: Other
Comparator / control treatment
The control group will receive a condensed version of the RuFIT physical activity programme, which will include discussion of the top-line physical activity messages delivered during the original programme (e.g. importance of stretching, warm-up, and the benefits of different exercise types), in addition to an introduction to the exercises performed during the RuFIT programme. This will be delivered during a 1-day training from the club trainer. All control participants will also be given a pedometer to monitor their step count. The 1-day training will occur the week after the final follow-up (i.e. both intervention and control participants will be followed up at the end of week 12, and then the 1-day training day will occur at the end of week 13).
Control group
Active

Outcomes
Primary outcome [1] 297259 0
Assess the feasibility of the programme, including acceptability of randomisation, the proposed measurements, study retention, and acceptability of the adapted programme. These measures will be assessed by self-report using questionnaires designed specifically for this study.
Timepoint [1] 297259 0
12 weeks.
Secondary outcome [1] 320216 0
Height will be measured using a stadiometer at the baseline and final follow-up visits.
Timepoint [1] 320216 0
12 weeks
Secondary outcome [2] 320219 0
Heart rate will be assessed using an automated sphygmomanometry.
Timepoint [2] 320219 0
12 weeks
Secondary outcome [3] 320220 0
Seated blood pressure will be assessed using an automated sphygmomanometry.
Timepoint [3] 320220 0
12 weeks
Secondary outcome [4] 320221 0
Bioelectrical impedance will be used to assess body fat.
Timepoint [4] 320221 0
12 weeks
Secondary outcome [5] 320222 0
Shuttle run test will be used to assess cardiovascular fitness.
Timepoint [5] 320222 0
12 weeks
Secondary outcome [6] 320223 0
Hip circumference will be assessed using a tape measure.
Timepoint [6] 320223 0
12 weeks
Secondary outcome [7] 320224 0
Waist circumference will be assessed using a tape measure.
Timepoint [7] 320224 0
12 weeks
Secondary outcome [8] 320225 0
Alcohol consumption will be assessed by self-report using a survey designed specifically for this study.
Timepoint [8] 320225 0
12 weeks
Secondary outcome [9] 320226 0
Fruit and vegetable consumption will be assessed by self-report using a survey designed specifically for this study.
Timepoint [9] 320226 0
12 weeks
Secondary outcome [10] 320493 0
Body mass index will be measured using the following equation: weight (as assessed by digital scales) in kg / height squared (as assessed by stadiometer).
Timepoint [10] 320493 0
12 weeks
Secondary outcome [11] 320495 0
Waist-to-hip ratio will be assessed by the ratio of the circumference of the waist (as measured by tape measure in cm) to that of the hips (as measured by tape measure in cm).
Timepoint [11] 320495 0
12 weeks
Secondary outcome [12] 320501 0
Bodyweight will be measured using digital scales at the baseline and final follow-up visits.
Timepoint [12] 320501 0
12 weeks

Eligibility
Key inclusion criteria
Overweight males (with a BMI of 25 kg/m2 or over) aged 25-65 years who are wanting to improve their physical fitness and diet; Are able to safely undertake physical activity; Can understand and read English; Are able to provide written consent to take part in the study.
Minimum age
25 Years
Maximum age
65 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Has been told by their doctor that they have a heart condition and that they should only do physical activity recommended by a doctor; Has pain in chest when doing physical activity; Has had pain in chest when not doing physical activity during the last month; Lose their balance because of dizziness or if they ever lose consciousness; Has a bone or joint problem (for example, back, knee, or hip) that could be made worse by a change in physical activity; Their doctor is currently prescribing drugs (for example, water pills) for blood pressure or a heart condition; Any other reason why they should not do physical activity.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Yes, using sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Men will be randomised in a 1:1 ratio to the intervention or control group using a randomisation table created by computer software. The randomisation process will be stratified (1:1) according to study centre.
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
Baseline characteristics (age, ethnicity, BMI) will be summarised using descriptive statistics. Continuous variables will be presented as mean and standard deviation (SD). Categorical variables will be presented as frequency and percentage. Treatment evaluation will be performed on the principle of intention to treat. All statistical tests will be two-sided and maintained at a 5% significance level. Multiple regression analysis will be used to evaluate the main treatment effect, adjusting for important confounding factors at baseline. Categorical variables will be reported as n and %. Simple chi-squared analyses will be used to evaluate the treatment effect on the proportions adherent to health behaviours at end of the programme period, with estimation of relative risks, 95% confidence intervals and two-sided p-values.
As this is a feasibility study, no power calculation will be performed to assess participant numbers.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
13/02/2016
Actual
13/02/2016
Date of last participant enrolment
Anticipated
17/02/2016
Actual
2/04/2016
Date of last data collection
Anticipated
Actual
25/06/2016
Sample size
Target
90
Accrual to date
Final
90
Recruitment outside Australia
Country [1] 7555 0
New Zealand
State/province [1] 7555 0
Auckland
Country [2] 7556 0
New Zealand
State/province [2] 7556 0
Dunedin

Funding & Sponsors
Funding source category [1] 292769 0
Government body
Name [1] 292769 0
Health Research Council
Country [1] 292769 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
The University of Auckland, Private Bag 92019, Auckland 1142.
Country
New Zealand
Secondary sponsor category [1] 291503 0
University
Name [1] 291503 0
University of Otago
Address [1] 291503 0
362 Leith St, North Dunedin, Dunedin 9016
Country [1] 291503 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294260 0
University of Auckland Human Participants Ethics Committee
Ethics committee address [1] 294260 0
Research Integrity Unit Level 10, Building 620 49 Symonds Street Auckland 1010
Ethics committee country [1] 294260 0
New Zealand
Date submitted for ethics approval [1] 294260 0
30/07/2014
Approval date [1] 294260 0
08/08/2015
Ethics approval number [1] 294260 0
015069

Summary
Brief summary
This study will investigate the feasibility of implementing the RuFIT programme
in overweight New Zealand (NZ) males, a notoriously difficult-to-engage and
under-researched group. The programme will be modified from the Scottish
Football Fans in Training (FFIT) programme, which has been shown to be highly
effective. The RuFIT programme (the first of its kind in NZ) aims to address
underlying barriers to male participation in healthy lifestyle programmes,
harnessing the psychology of sports fandom, and appealing to deeply rooted
values in NZ culture about rugby being a ‘manly’ exercise. Findings from the
feasibility study will inform a large effectiveness trial of the RuFIT programme.
The feasibility study follows on from the pilot study, which was conducted earlier
in 2015. The pilot study was undertaken in 20 men and was
designed to assess the components of the RuFIT programme in NZ men. Based
on the feedback provided by the participants, the programme delivered in the
RuFIT feasibility study will be better tailored to address the needs of Pacific men.
In particular, more focus will be placed on the role of family members supporting
the men, and healthy eating for different groups.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 63090 0
Prof Ralph Maddison
Address 63090 0
The University of Auckland, Private Bag 92019, Auckland 1142.
Country 63090 0
New Zealand
Phone 63090 0
+64 9 3737 999 x 87863
Fax 63090 0
Email 63090 0
r.maddison@auckland.ac.nz
Contact person for public queries
Name 63091 0
Dr Samantha Marsh
Address 63091 0
The University of Auckland, Private Bag 92019, Auckland 1142.
Country 63091 0
New Zealand
Phone 63091 0
+64 9 3737 999 x 87863
Fax 63091 0
Email 63091 0
sam.marsh@auckland.ac.nz
Contact person for scientific queries
Name 63092 0
Dr Samantha Marsh
Address 63092 0
The University of Auckland, Private Bag 92019, Auckland 1142.
Country 63092 0
New Zealand
Phone 63092 0
+64 9 3737 999 x 87863
Fax 63092 0
Email 63092 0
sam.marsh@auckland.ac.nz

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What supporting documents are/will be available?

Current supporting documents:


Updated to:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
23410Study protocol   

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