Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000304134
Ethics application status
Approved
Date submitted
25/02/2019
Date registered
27/02/2019
Date last updated
5/09/2019
Date data sharing statement initially provided
27/02/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The Fitness and Health Study: The role of adiposity and cardiorespiratory fitness on health risk factors in overweight/obese children
Scientific title
The effect of adiposity and cardiorespiratory fitness on cardiovascular and metabolic risk factors in overweight/obese children
Secondary ID [1] 297521 0
NIL
Universal Trial Number (UTN)
U1111-1229-2050
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 311729 0
Condition category
Condition code
Metabolic and Endocrine 310350 310350 0 0
Normal metabolism and endocrine development and function
Cardiovascular 310351 310351 0 0
Normal development and function of the cardiovascular system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Study Design:
Parents and children presenting at Fiona Stanley Hospital identified as being overweight or obese will be provided with information related to the project. Thereafter, parents will then contact the researchers to express interest in their participation and they will be provided with the informed consent. In addition, parents and children will then come to Murdoch University for a site visit and a demonstration of the activities which will be completed. Further questions will be answered and informed consent (parent) and assent (child) obtained. Upon obtaining consent, participants will then be invited to attend the Exercise Physiology Clinic at Murdoch University for the collection of preliminary measurements and baseline data. Following baseline assessments, participants will then begin their 16-week exercise training intervention. Mid-intervention assessments will occur during Week 8 to assess aerobic fitness and strength. At least 24 hours after the last training session in Week 16, but no more than 96 hours after the last training session, participants will then complete their final assessment that is similar to the assessments at baseline.

Procedures:
Baseline testing will include body anthropometrics (height, weight, waist circumference and a dual energy X-ray absorptiometry [DXA] scan), aerobic fitness assessment (VO2 peak test performed on a cycle ergometer), a repetition max (RM) test for the bench press and leg press exercise, a 4-exercise functional movement screen (FMS), diet history (24h dietary recall conducted on 3 separate occasions representing different days), 7-day physical activity monitoring (Actigraph) and an appetite questionnaire. Additionally, participants will have their baseline blood sample taken at Fiona Stanley Hospital.
Upon the completion of baseline assessments, participants will commence their first exercise training session of the intervention. Over the subsequent 16 weeks, participants will be trained (two times per week; 40-60 minutes) using a mix of aerobic, resistance and movement skills (coordination) program. These will be individualised and progressively increased over the weeks with the aim of improving the different facets of fitness (e.g. aerobic fitness and strength). The aerobic exercise portion of the training program will be completed at approximately ~60-70% of VO2 peak for 20 minutes. The intensity of the exercises will be tailored/progressed based on the participant’s performance in the VO2peak test completed at baseline and at mid-intervention (Week 8). The resistance exercises will be conducted in a circuit fashion that incorporates exercises involving both the upper and lower body (e.g. leg press, goblet squats, push ups and lat pulldown exercises) for an approximate duration of 20 minutes. Progression in the intensity of resistance exercises will utilise a 2x2 rule (i.e. intensity is increased if an individual is able to successfully complete 2 or more repetitions in the last set on 2 consecutive workouts). Lastly, the movement skills portion of the training will incorporate different sports (e.g. basketball, soccer, tennis and etc.) for approximately 20mins with the aim of maintaining average heart rate during this period between 60-70% of heart rate max. During the sessions, we will also be encouraging increased physical activity (monitored with the activity tracker) and improved sleep habits (earlier bed-times where appropriate; currently, children in the program have demonstrated poor sleep behaviours such as going to bed between 1-3am on weekdays). The training workload (volume and intensity) will be monitored closely by the exercise physiologist at every session. All exercise sessions will be recorded in a logbook with attendance taken as well as sessional RPE for each individual training session over the 16-week period.

At the completion of the intervention, post-intervention assessments will be completed in one session at Murdoch University with the assessments being similar to those at baseline. This test will occur at least 24h after, but not more than 72h, the last exercise training session.
Intervention code [1] 313760 0
Behaviour
Intervention code [2] 313772 0
Lifestyle
Comparator / control treatment
No control group
Control group
Active

Outcomes
Primary outcome [1] 319225 0
Changes in body anthropometrics would be analysed using composite measures of body mass index (calculated with height (stadiometer) and weight (digital weighing scale) , waist circumference (tape measure) and body fat percentage (DXA scan).
Timepoint [1] 319225 0
Prior to the start of the 16-week training intervention during baseline assessment (pre-intervention: primary time point), mid-intervention assessment (week 8) and at least 24 hours after the last training session in week 16, but no more than 96 hours after the last training session (post-intervention: primary end point).
Primary outcome [2] 319226 0
Changes in cardiovascular fitness levels as measured by maximal oxygen consumption (VO2max) during a cycle ergometer testing protocol
Timepoint [2] 319226 0
Prior to the start of the 16-week training intervention during baseline assessment (pre-intervention: primary time point), mid-intervention assessment (week 8) and at least 24 hours after the last training session in week 16, but no more than 96 hours after the last training session (post-intervention: primary end point).
Secondary outcome [1] 367371 0
Changes in glycaemic control as done through the analysis of composite measures that include: fasting glucose, fasting insulin and insulin sensitivity (HOMA-IR). Blood samples will be sent to an external provider (PathWest) for the analysis of fasting glucose and insulin.
Timepoint [1] 367371 0
Prior to the start of the 16-week training intervention during baseline assessment and at least 24 hours after the last training session in week 16, but no more than 96 hours after the last training session (post-intervention).
Secondary outcome [2] 367372 0
Dietary history will be analysed using a 24h dietary recall that will be completed using a three pass method on 3 separate occasions.
Timepoint [2] 367372 0
Prior to the start of the 16-week training intervention during baseline assessment (pre-intervention), at mid-intervention (Week 8) and at least 24 hours after the last training session in week 16, but no more than 96 hours after the last training session (post-intervention). For both pre-, mid- and post-intervention, a total of 9 24h dietary recalls (3 occasions over a period of 2 weeks for each time point) will be completed.
Secondary outcome [3] 367373 0
Changes in physical activity will be analysed using composite measures of activity monitoring (Actigraph monitor) and a 7-day physical activity diary (which will be used to sync with the raw data extracted from the Actigraph monitor). The components of physical activity that will be assessed include: 1) total sedentary time and 2) total time spent at different activity levels (i.e. light, moderate and vigorous).
Timepoint [3] 367373 0
Prior to the start of the 16-week training intervention during baseline assessment (pre-intervention) and at least 24 hours after the last training session in week 16, but no more than 96 hours after the last training session (post-intervention). For both pre-intervention and post-intervention, individuals will have the Actigraph monitors on for a duration of 1 week.
Secondary outcome [4] 367374 0
Changes in movement patterns will be analysed using a functional movement screening assessment that will involve 4 activities (hop, 20m sprint, overhand throw and jumping for distance).
Timepoint [4] 367374 0
Prior to the start of the 16-week training intervention during baseline assessment (pre-intervention), mid-intervention assessment (week 8) and at least 24 hours after the last training session in week 16, but no more than 96 hours after the last training session (post-intervention).
Secondary outcome [5] 367375 0
Changes in appetite will be analysed using a Three Factor Eating Questionnaire (TFEQ)
Timepoint [5] 367375 0
Prior to the start of the 16-week training intervention during baseline assessment (pre-intervention), mid-intervention assessment (week 8) and at least 24 hours after the last training session in week 16, but no more than 96 hours after the last training session (post-intervention).

Eligibility
Key inclusion criteria
Overweight or obese (greater than or equal to 27; according to age-specified BMI) individuals
Minimum age
6 Years
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria is as follow: (a) individuals who have participated in organized exercise training in the previous 6 months; (b) individuals that have severe physical or mental disability that may impair their participation in the study; (c) individuals that have a medical contraindication to training; and (d) individuals who have cardiorespiratory or respiratory diseases that will be made worse with exercise.

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)
NIL
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
NIL
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
NA
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Outcomes will be explored using bivariate and hierarchical linear regression models. We anticipate modelling two independent variables with one dependent variable. The models are expected to include one dependent variable (e.g. HOMA-IR) and two independent variables modelled in step one (e.g. BMI, LBM) and step two (e.g. VO2 peak, OUES) using backwards elimination. The VO2 peak and OUES scores may also be expressed relative to body weight or lean body mass (ml/min/kg) which will enable another factor to be added into the model. Additional outcome measures (i.e. changes in CRF, BMI, BF%) will be analysed using a repeated measures ANCOVA (Covariate: baseline values).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
4/03/2019
Actual
27/03/2019
Date of last participant enrolment
Anticipated
7/10/2019
Actual
Date of last data collection
Anticipated
31/01/2020
Actual
Sample size
Target
30
Accrual to date
14
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 302081 0
Charities/Societies/Foundations
Name [1] 302081 0
Spinnaker Health Research Foundation
Country [1] 302081 0
Australia
Primary sponsor type
University
Name
Murdoch University
Address
90 South Street, Murdoch, Perth Western Australia 6150
Country
Australia
Secondary sponsor category [1] 301898 0
None
Name [1] 301898 0
Address [1] 301898 0
Country [1] 301898 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302760 0
Murdoch University Human Research Ethics Committee
Ethics committee address [1] 302760 0
90 South Street, Murdoch, Perth Western Australia 6150
Ethics committee country [1] 302760 0
Australia
Date submitted for ethics approval [1] 302760 0
22/11/2018
Approval date [1] 302760 0
30/01/2019
Ethics approval number [1] 302760 0
2018/234

Summary
Brief summary
The number of children who are overweight or obese continues to grow in Australia. These children risk getting heart disease and diabetes in their teens or as adults. The main ways for preventing these health problems in children are by modifying diet and exercise. Most individuals working in the healthcare system are for this reason focussed on increasing children’s physical activity levels. While physical activity and fitness are related, they are distinct, wherein physical activity focuses on increasing steps and movement while an increase in fitness also includes a purposeful improvement in the number of steps and movements taken. This program is specifically interested in learning about the importance of improving fitness, not just increasing activity, for preventing heart disease and diabetes in children who are overweight or obese.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 91302 0
A/Prof Timothy Fairchild
Address 91302 0
College of Science, Health, Engineering and Education
Murdoch University
90 South Street, Murdoch WA 6150
Country 91302 0
Australia
Phone 91302 0
+61 8 9360 2959
Fax 91302 0
Email 91302 0
[email protected]
Contact person for public queries
Name 91303 0
Mr Shaun Teo
Address 91303 0
College of Science, Health, Engineering and Education
Murdoch University
90 South Street, Murdoch WA 6150
Country 91303 0
Australia
Phone 91303 0
+61 423 716 780
Fax 91303 0
Email 91303 0
[email protected]
Contact person for scientific queries
Name 91304 0
Mr Shaun Teo
Address 91304 0
College of Science, Health, Engineering and Education
Murdoch University
90 South Street, Murdoch WA 6150
Country 91304 0
Australia
Phone 91304 0
+61 423 716 780
Fax 91304 0
Email 91304 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
No additional documents have been identified.