Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000691741
Ethics application status
Approved
Date submitted
12/06/2013
Date registered
24/06/2013
Date last updated
29/11/2021
Date data sharing statement initially provided
29/11/2021
Date results information initially provided
29/11/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Exercise programme to improve fitness and health in adolescents
Scientific title
Feasibility of a group-based exercise programme to improve health and increase cardiorespiratory fitness and usual activity in less-active Pacific and Maori adolescents
Secondary ID [1] 282657 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes 289358 0
Cardiorespiratory fitness 289359 0
Condition category
Condition code
Cardiovascular 289694 289694 0 0
Normal development and function of the cardiovascular system
Physical Medicine / Rehabilitation 289695 289695 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Exercise programme, three times per week lasting for 1- 1.5 hours after school for 12 weeks. The moderate intensity exercise sessions will be run by two post-graduate Health Science and Exercise and Sports Science students. The intervention will use the principles of motivational interviewing and involve games and exercise routines designed by the post-graduate students with advice from the Sports and Exercise supervisor and in consultation with students. A healthy snack (e.g. fruit and milk/water) will be offered at each session. The post-graduate students will discuss achieving recommended levels of physical activity in every-day life and setting physical activity goals.
Intervention code [1] 287323 0
Prevention
Intervention code [2] 287324 0
Lifestyle
Comparator / control treatment
No control
Control group
Uncontrolled

Outcomes
Primary outcome [1] 289788 0
Cardiorespiratory fitness at 6 weeks as assessed by the 1-mile walk test.
(Refs: Kline GM, Porcari JP, Hintermeister R, et. al. 1987. Estimation of VO2 Max from a one mile track walk, gender, age, and body weight. Medicine and Science in sports and Exercise. 19:253-59; Nieman DC (1999) Exercise Testing and Prescription: A Health-Related Approach (4th Ed.). Mountain View, CA: Mayfield Publishing Company, pp 90.)
Timepoint [1] 289788 0
Baseline and 6 weeks
Primary outcome [2] 289789 0
Insulin resistance at 6 weeks, as assessed using the homeostatic model assessment (HOMA) method from a fasting blood sample.
Timepoint [2] 289789 0
Baseline and 6 weeks
Secondary outcome [1] 303240 0
Usual physical activity levels, as assessed by the international physical activity questionnaire (IPAQ) - short form and accelerometers worn for 1 week. (A subsample will also carry smart phones and answer 2 activity questions per day for 1 week to triangulate physical activity measures)
Timepoint [1] 303240 0
Baseline and 6 weeks
Secondary outcome [2] 303241 0
Waist circumference (taken as the smallest circumference measured between the lower ribs and the iliac crest to the nearest 0.5cm).
Timepoint [2] 303241 0
Baseline and 6 weeks
Secondary outcome [3] 303242 0
Serum glycated haemoglobin (HbA1c) as measured from a blood sample
Timepoint [3] 303242 0
Baseline and 6 weeks
Secondary outcome [4] 303243 0
Blood pressure - assessed after participant has been sitting quietly for at least 5 minutes. Two measurements will be recorded with another 5 minutes between readings. The average of the two readings will be used.
Timepoint [4] 303243 0
Baseline and 6 weeks
Secondary outcome [5] 303244 0
Serum lipid profile - assessed by fasting blood test.
Timepoint [5] 303244 0
Baseline and 6 weeks

Eligibility
Key inclusion criteria
Adolescents attending a local secondary school with a predominantly Pacific and Maori role and within a lower socio-economic region, who are not currently participating in regular sporting or exercise (less than 2 sessions per week).
Minimum age
13 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participating in two or more regular sporting or exercise sessions per week.

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)
No randomisation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
No randomisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Pilot
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Regression models

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
24/06/2013
Actual
24/06/2013
Date of last participant enrolment
Anticipated
30/08/2013
Actual
8/08/2013
Date of last data collection
Anticipated
Actual
25/09/2013
Sample size
Target
30
Accrual to date
Final
18
Recruitment outside Australia
Country [1] 5141 0
New Zealand
State/province [1] 5141 0

Funding & Sponsors
Funding source category [1] 287440 0
Government body
Name [1] 287440 0
Ministry of Health
Country [1] 287440 0
New Zealand
Primary sponsor type
University
Name
Department of General Practice & Primary Health Care, University of Auckland,
Address
Private Bag 92019,
Auckland,
Country
New Zealand
Secondary sponsor category [1] 286184 0
None
Name [1] 286184 0
Address [1] 286184 0
Country [1] 286184 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289415 0
University of Auckland Human Participants Ethics Committee
Ethics committee address [1] 289415 0
Private Bag 92019,
Auckland
Ethics committee country [1] 289415 0
New Zealand
Date submitted for ethics approval [1] 289415 0
16/05/2013
Approval date [1] 289415 0
19/06/2013
Ethics approval number [1] 289415 0
UAHPEC 9819

Summary
Brief summary
The aim of this pilot study is to test the feasibility of a group-based exercise program over 6 weeks, test research processes and explore effects on cardio-respiratory fitness (VO2max), insulin resistance, glycosylated haemoglobin (HbAlc), blood pressure, waist circumference, and physical activity levels in less-active Pacific and Maori adolescents at a local decile 1 secondary school.
Methods:
Study design: Before-after study
Setting: Community gym
Study population: Adolescents attending low decile college who are doing less than two organised exercise or sports sessions per week on a regular basis.
Intervention: 6 week exercise program, three times per week lasting for 1- 1.5 hours. The exercise sessions were run by post-graduate Health Science and Exercise and Sports Science students. The intervention used the principles of motivational interviewing and involved games and exercise routines designed by the post-graduate students with advice from the Sports and Exercise supervisor and in consultation with students. A healthy snack (e.g. fruit and milk/water) was offered at each session. The post-graduate students discussed achieving recommended levels of physical activity in every-day life and setting physical activity goals.
Outcome measures were collected after informed consent and immediately before the start of the 6-week exercise program.
Primary outcome measures: (assessed at baseline and 6 weeks)
1. Cardio-respiratory fitness (VO2max): as assessed by the ‘1-mile walk test’.
2. Insulin resistance: calculated according to Homeostatic Model, using fasting blood glucose and insulin levels 2
Secondary outcomes: (assessed at baseline and 6 weeks)
1. Usual physical activity levels: using the short form of the international physical activity questionnaire (IPAQ)3, (and accelerometer and smart phone on a sub-sample)
2. Waist circumference
3. HbA1c
4. Blood pressure
5. Fasting lipid profile
Attendance at exercise sessions and any injuries was also recorded.
Trial website
Trial related presentations / publications
1. CHANSAVANG Y, ELLEY CR, MCCAFFREY B, DAVIDSON C, DEWES O, DALLECK L, Feasibility of an after-school group-based exercise and lifestyle programme to improve cardiorespiratory fitness and health in less-active Pacific and Maori adolescents, Journal of Primary Health Care, 2015, Vol 7 (1), pp 57-64
Public notes

Contacts
Principal investigator
Name 40686 0
A/Prof Carolyn Raina Elley
Address 40686 0
Dept General Practice and Primary Health Care,
University of Auckland,
Private Bag 92019
Auckland
Country 40686 0
New Zealand
Phone 40686 0
+64 9 3737599
Fax 40686 0
Email 40686 0
[email protected]
Contact person for public queries
Name 40687 0
A/Prof Carolyn Raina Elley
Address 40687 0
Dept General Practice and Primary Health Care,
University of Auckland,
Private Bag 92019
Auckland
Country 40687 0
New Zealand
Phone 40687 0
+64 9 3737599
Fax 40687 0
Email 40687 0
[email protected]
Contact person for scientific queries
Name 40688 0
A/Prof Carolyn Raina Elley
Address 40688 0
Dept General Practice and Primary Health Care,
University of Auckland,
Private Bag 92019
Auckland
Country 40688 0
New Zealand
Phone 40688 0
+64 9 3737599
Fax 40688 0
Email 40688 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
I don't have the resources to arrange this


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes CHANSAVANG Y, ELLEY CR, MCCAFFREY B, DAVIDSON C, D... [More Details]

Documents added automatically
No additional documents have been identified.