Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000069156
Ethics application status
Approved
Date submitted
16/01/2019
Date registered
18/01/2019
Date last updated
16/06/2021
Date data sharing statement initially provided
18/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
RUgby Fans In Training (RUFIT-NZ): a healthy lifestyle programme for overweight men aged 30-65 years.
Scientific title
RUgby Fans In Training (RUFIT-NZ): A Randomised control trial to determine the effectiveness and cost-effectiveness of a healthy lifestyle programme on bodyweight in overweight men aged 30-65 years.
Secondary ID [1] 297090 0
None
Universal Trial Number (UTN)
U1111-1245-0645
Trial acronym
RUFIT-NZ
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Overweight and/or obesity 311105 0
Sedentary Behaviour 311107 0
Condition category
Condition code
Public Health 309736 309736 0 0
Health promotion/education
Diet and Nutrition 309763 309763 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A multi-centre, two-arm, parallel randomised controlled trial designed to assess effectiveness of the RUFIT-NZ programme, with respect to bodyweight, diet, physical activity, and alcohol use.
The programme will involve a group-based healthy living and weight loss programme, delivered in 12 x weekly two-hour sessions at the Rugby club’s training facility, by a trained RUFIT coach.
Each two-hour session will cater for approximately 20 people and include a workshop-based education component, the content of which will include behaviour change (goal setting, problem solving, self-monitoring) and environmental (leverage of social support) strategies. As well as an individually-tailored exercise training programme (see details below).
The education components delivered in the group setting over each of the 12 weeks are
Week 1 - "Lifestyle approach to health" and "goal setting" delivered by rugby club coaches
Week 2 - "Nutrition", delivered by rugby club nutritionists
Week 3 - "Planning and Budgeting - Nutrition", delivered by rugby club nutritionists
Week 4 - "Behaviour Change", delivered by rugby club coaches
Week 5 - "Mindful Eating", delivered by rugby club nutritionists
Week 6 - "Injury Prevention", delivered by rugby club coaches
Week 7 - "Question and Answer" section (Nutrition), delivered by rugby club nutritionists
Week 8 - "Alcohol and Health", delivered by rugby club coaches
Week 9 - "Question and Answer" section (physical activity), delivered by rugby club coaches
Week 10 - "Sleep and Sedentary Behaviour", delivered by rugby club coaches
Week 11 - "Long-term Behaviour Change" and "Overcoming Obstacles", delivered by rugby club coaches
Week 12 - "Wrap-up" and "Motivational Talk" delivered by rugby club coaches.
The rugby coaches and nutritionists will be trained in the intervention and given slides, manuals, and seminar on the content for the education component.
Each participant will receive a booklet containing the slides presented and forms to monitor their step-counts, weekly food consumption, weight, and their weekly goals.
The individually-tailored exercise training programmes are strength and conditioning based delivered and prepared by the rugby club coaches. Coaches will create programmes for all participants to complete but that cater to individual fitness abilities. For example, if the group is required to run the coaches will encourage those whose abilities do not meet those requirements to walk.
Adherence to the intervention will be monitored through measuring bodyweight, diet, physical activity, and alcohol use at baseline, 12 weeks, and 52 weeks.
Participants will be randomised to either the 12-week RUFIT-NZ intervention programme, or the wait-list control group.
Intervention code [1] 313365 0
Lifestyle
Intervention code [2] 313366 0
Behaviour
Comparator / control treatment
The wait-list control group will continue with their usual lifestyle for 52 weeks after which they will be offered the RUFIT-NZ programme for 12 weeks.
Control group
Active

Outcomes
Primary outcome [1] 318698 0
Body Weight: Assessed by comparing the weight of the intervention group to the control group measured by a digital weighing scale.
Timepoint [1] 318698 0
Baseline, 12 weeks (post intervention commencement), 52 weeks after baseline (primary)
Secondary outcome [1] 365755 0
Waist Circumference: Assessed objectively using standard procedures with a tape measure.
Timepoint [1] 365755 0
Baseline, 12 weeks (post intervention commencement), 52 weeks after baseline.
Secondary outcome [2] 365757 0
Blood Pressure: Measured using an electronic blood pressure cuff.
Timepoint [2] 365757 0
Baseline, 12 weeks (post intervention commencement), 52 weeks after baseline.
Secondary outcome [3] 365758 0
Aerobic Fitness: Assessed by timing the duration of a 6km cycle ergometer test.
Timepoint [3] 365758 0
Baseline, 12 weeks (post intervention commencement), 52 weeks after baseline.
Secondary outcome [4] 365759 0
Strength Battery: Assessed by counting the number of press-ups completed in 60 seconds.
Timepoint [4] 365759 0
Baseline, 12 weeks (post intervention commencement), 52 weeks after baseline.
Secondary outcome [5] 365760 0
Sit to stand test: Assessed by counting the number of times the participants move from sitting to standing in 60 seconds.
Timepoint [5] 365760 0
Baseline, 12 weeks (post intervention commencement), 52 weeks after baseline.
Secondary outcome [6] 365761 0
Physical Activity: Measured objectively using Acti-graph accelerometers worn for seven days, and subjectively through the Godin Leisure Time Questionnaire which assesses the duration and frequency of strenuous, moderate, and light activity over the previous seven days.
Timepoint [6] 365761 0
Baseline, 12 weeks (post intervention commencement), 52 weeks after baseline.
Secondary outcome [7] 365762 0
Sleep: Measured by questions from the NZ Health Survey
Timepoint [7] 365762 0
Baseline, 12 weeks (post intervention commencement), 52 weeks after baseline.
Secondary outcome [8] 365763 0
Diet: Assessed by the NZ Health Survey which measures consumption of fruit, vegetable, discretionary foods, and sugar sweetened beverages over the last seven days.
Timepoint [8] 365763 0
Baseline, 12 weeks (post intervention commencement), 52 weeks after baseline.
Secondary outcome [9] 365764 0
Alcohol Intake: Assessed using the Alcohol Use Disorders Identification Test to calculate the number of alcohol units consumed per week.
Timepoint [9] 365764 0
Baseline, 12 weeks (post intervention commencement), 52 weeks after baseline.
Secondary outcome [10] 365765 0
Smoking: Assessed by questioning the participants smoking habits over the previous year.
Timepoint [10] 365765 0
Baseline, 12 weeks (post intervention commencement), 52 weeks after baseline.
Secondary outcome [11] 365766 0
Cost-effectiveness: Assessed by calculating the direct cost of the programme through health care utilisation, Ministry of Health datasets, and personal costs.
Timepoint [11] 365766 0
52 weeks after baseline.
Secondary outcome [12] 365769 0
Implementation Potential: Assessed by using the RE-AIM framework which collects information on the Reach, Effectiveness, Adoption, Implementation, and Maintenance of an intervention through a combination of the measures described above and through semi-structured interviews with a sub-scale of participants and coaches from RUFIT-NZ.
Timepoint [12] 365769 0
Baseline, 12 weeks (post intervention commencement), 52 weeks after baseline.
Secondary outcome [13] 365770 0
Health-related quality of life: Measured using the New Zealand EQ-5D Tariff 2.
Timepoint [13] 365770 0
Baseline, 12 weeks (post intervention commencement), 52 weeks after baseline.
Secondary outcome [14] 365771 0
Serious Adverse Events (SAE): Recorded throughout the intervention if, and when they occur.
Potential exercise-related SAEs such as heart attacks, hypotension, and hypertension are assessed at pre-screening and at baseline by measuring blood pressure using automated blood pressure cuffs, and measuring the participants readiness to begin physical activity thorough the Physical Activity Readiness Questionnaire (PAR-Q). Any participants who do not meet the criteria of the PAR-Q or at the time of testing have a blood pressure recorded as 160/110 or higher are required to get permission from their General Practitioner (GP) to continue with the study. Participants must bring the signed slip from their GP otherwise they will not be permitted to proceed with the fitness test and the remainder of the programme.
Timepoint [14] 365771 0
12 weeks (post intervention commencement), 52 weeks after baseline.

Eligibility
Key inclusion criteria
Inclusion Criteria:

Men aged between 30-65 years who are overweight (defined as having a BMI 28kg/m2 or higher), can speak and write in English, give informed electronic consent, and who meet the Physical Activity Readiness Questionnaire criteria or (if not) provide consent from their physician to participate in the study.
Minimum age
30 Years
Maximum age
65 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria:
Participants who are currently participating in another healthy lifestyle programme or are terminally unable to complete the 1 year duration of the intervention.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation using a 1:1 ratio performed by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified block randomisation will occur based on baseline BMI category, self-reported ethnicity (Maori vs. non-Maori), and study centre with variable block sizes of 2 or 4.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Power calculation: A sample size of 308 participants (154 per arm) will provide 90% power at 5% significance level (two-sided) to detect a clinically significant 5kg difference on the primary outcome between the two groups at 52 weeks, assuming a standard deviation (SD) of 12 kg and allowing for 20% loss to follow up.
Analysis: Treatment evaluation will be performed on the principle of intention-to-treat (ITT). All statistical tests will be two-sided at a 5% significance level. The primary outcome will be evaluated using the analysis of covariance model, adjusting for baseline outcome value and stratification factors at baseline. Multiple imputations will be used on missing primary outcome data in the main ITT analysis. Sensitivity analyses using different assumptions on the missing data including complete case analysis will also be conducted to test the robustness of main trial findings. The consistency of intervention effects between Maori and non-Maori participants will be explored and tested using an interaction term between treatment and ethnic groups. Generalised linear regression models will be used to analyse secondary outcomes measured at 12 and/or 52 weeks, using a link function appropriate to the distribution of outcome variable. For repeated outcome measures, random effect mixed models will be used to take into account the correlated data collected from the same participant using with a random subject effect. Due to the coronavirus outbreak and national lockdown announced on Wednesday 26th March 2020, a planned interim analysis will be added to include all participants who have completed final follow up at 52 weeks (Group 1) and those who have finished 12-week assessment and is due for final follow-up in June/July 2020 (Group 2). We will continue with the study as planned to collect 52-week data on this group, and conduct an interim analysis on all participants in Group 1 and 2.

The remaining randomised participants who have only completed baseline and 3-4 RUFIT-NZ sessions (Group 3) will be postponed until next year, and therefore excluded from this interim analysis.

Under this unexpected circumstance, we plan to conduct a full interim analysis on all primary and secondary outcomes if the data are available. A post-hoc power calculation will be carried out on the primary outcome using the reduced sample size to assess its impact on the final trial evaluation.

The final trial results will be reported according to the CONSORT 2010 guidelines.

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Participant recruitment difficulties
Safety concerns
Other reasons/comments
Other reasons
The uncertainty of timelines due to the COVID-19 pandemic.
Date of first participant enrolment
Anticipated
21/01/2019
Actual
21/01/2019
Date of last participant enrolment
Anticipated
1/02/2020
Actual
24/02/2020
Date of last data collection
Anticipated
8/02/2020
Actual
22/10/2020
Sample size
Target
308
Accrual to date
Final
378
Recruitment outside Australia
Country [1] 21202 0
New Zealand
State/province [1] 21202 0
Auckland/Otago/Canterbury

Funding & Sponsors
Funding source category [1] 301657 0
Government body
Name [1] 301657 0
Health Research Council
Country [1] 301657 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] 301368 0
University
Name [1] 301368 0
University of Otago
Address [1] 301368 0
University of Otago, PO Box 56, Dunedin, 9010
Country [1] 301368 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302377 0
University of Auckland Human Ethics Committee
Ethics committee address [1] 302377 0
Ethics committee country [1] 302377 0
New Zealand
Date submitted for ethics approval [1] 302377 0
Approval date [1] 302377 0
20/09/2018
Ethics approval number [1] 302377 0
021888

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

Contacts
Principal investigator
Name 90018 0
Prof Ralph Maddison
Address 90018 0
National Institute for Health Innovation, Tamaki Building 730 261 Morrin Road, St Johns, University of Auckland
AUCKLAND 1072
Country 90018 0
New Zealand
Phone 90018 0
+64 9 373 7599
Fax 90018 0
Email 90018 0
[email protected]
Contact person for public queries
Name 90019 0
Amanda Calder
Address 90019 0
National Institute for Health Innovation, Tamaki Building 730 261 Morrin Road, St Johns, University of Auckland
AUCKLAND 1072
Country 90019 0
New Zealand
Phone 90019 0
+64 9 373 7599
Fax 90019 0
Email 90019 0
[email protected]
Contact person for scientific queries
Name 90020 0
Ralph Maddison
Address 90020 0
National Institute for Health Innovation, Tamaki Building 730 261 Morrin Road, St Johns, University of Auckland
AUCKLAND 1072
Country 90020 0
New Zealand
Phone 90020 0
+64 9 373 7599
Fax 90020 0
Email 90020 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


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
EmbaseRugby Fans in Training New Zealand (RUFIT-NZ): Protocol for a randomized controlled trial to assess the effectiveness and cost-effectiveness of a healthy lifestyle program for overweight men delivered through professional rugby clubs in New Zealand.2020https://dx.doi.org/10.1186/s13063-019-4038-4
EmbaseRugby Fans in Training New Zealand (RUFIT NZ): a randomized controlled trial to assess the effectiveness of a healthy lifestyle program for overweight men delivered through professional rugby clubs.2023https://dx.doi.org/10.1186/s12966-022-01395-w
N.B. These documents automatically identified may not have been verified by the study sponsor.