Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000862943
Ethics application status
Approved
Date submitted
9/08/2011
Date registered
15/08/2011
Date last updated
26/03/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Whanau Pakari: a multidisciplinary intervention for child and adolescent obesity.
Scientific title
In children and adolescents with a body mass index (BMI) of >99th percentile, do those who are assessed as "ready for change", and receive a multi-disciplinary intervention programme improve their BMI, physical activity, dietary behaviour, and attitude towards healthy eating more than those "ready for change" who receive current standard of care?
Secondary ID [1] 262781 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 270491 0
Condition category
Condition code
Metabolic and Endocrine 270647 270647 0 0
Metabolic disorders
Diet and Nutrition 270663 270663 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Physical Activity - fitness assessments and knowledge of importance of physical fitness at 0, 6, 12, 18, 24 and 60 months. Initial home visits by Active Families co-ordinator (1 hour), then weekly activity sessions for 40 weeks during the year (1.5 hours per session).
Dietary education - dietician input and initial home visits (1 hour), with food frequency questionnaire and knowlege of importance of diet at 0, 6, 12, 18, 24 and 60 months.
Psychology input - input as group at commencement of intervention (2 x 1 hour sessions), and then at family/individual level as indicated. Assessment of Paediatric quality of life, with assessment of anxiety and depression.
Intervention code [1] 269124 0
Lifestyle
Comparator / control treatment
Brief dietary education by means of pamphlet, assessment of knowledge of importance of diet and food frequency questionnaire at 0, 6, 12, 18, 24 and 60 months.
Physical activity questionnaire and knowledge of importance of physical activity at 0, 6, 12, 18, 24, and 60 months.
Paediatric quality of life, anxiety and depression assessment at 0, 6, 12, 18, 24 and 60 months.
Control group
Active

Outcomes
Primary outcome [1] 269371 0
BMI reduction of 0.5SDS, as assessed by height and weight at 0, 6, 12, 18, 24 and 60 months.
Timepoint [1] 269371 0
0, 6, 12, 18, 24 and 60 months
Primary outcome [2] 269382 0
Improvement in quality of life (Paediatric QoL score)
Timepoint [2] 269382 0
0, 12, 24 and 60 months
Primary outcome [3] 269383 0
Improvement in physical activity (heart rate, accelerometer data, physical activity questionnaire)
Timepoint [3] 269383 0
0, 6, 12, 18, 24 and 60 months
Secondary outcome [1] 287522 0
Improvement in dietary behaviour (food frequency questionnaire)
Timepoint [1] 287522 0
0, 6, 12, 18, 24 and 60 months
Secondary outcome [2] 287523 0
Reduced sedentary activity (physical activity questionnaire)
Timepoint [2] 287523 0
0, 6, 12, 18, 24 and 60 months
Secondary outcome [3] 287524 0
Improved glycaemic control (HbA1c, fasting insulin, glucose, lipids)
Timepoint [3] 287524 0
0, 12, 24 and 60 months

Eligibility
Key inclusion criteria
BMI>98th centile (obese) according to WHO growth charts, or >91st centile (overweight) with significant weight-related co-morbidities. "Ready for change" as assessed by questionnaire and overall assessment of level of motivation by Healthy Lifestyles Co-ordinator on interview. Committed family member.
Minimum age
5 Years
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Significant co-morbidities: i.e. any medical condition serious enough to make it impossible for a child/adolescent to embark on a programme of increasing physical activity.

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)
Seen by Healthy Lifestyles Co-ordinator after referral to obesity service, family assessed for "readiness to change", consent obtained, then randomised (stratified by ethnicity and gender). Allocation not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation by minimisation (age and ethnicity) using Minims computer programme.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Nil
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/11/2011
Actual
9/01/2012
Date of last participant enrolment
Anticipated
31/07/2014
Actual
1/08/2014
Date of last data collection
Anticipated
1/09/2019
Actual
Sample size
Target
214
Accrual to date
Final
203
Recruitment outside Australia
Country [1] 3769 0
New Zealand
State/province [1] 3769 0

Funding & Sponsors
Funding source category [1] 269620 0
Hospital
Name [1] 269620 0
Taranaki Base Hospital
Country [1] 269620 0
New Zealand
Primary sponsor type
Hospital
Name
Taranaki Base Hospital
Address
David Street,
New Plymouth 4310,
Taranaki
Country
New Zealand
Secondary sponsor category [1] 266652 0
University
Name [1] 266652 0
University of Auckland
Address [1] 266652 0
Liggins Institute,
The University of Auckland,
Private Bag 92019,
Victoria Street West,
Auckland 1142
Country [1] 266652 0
New Zealand
Other collaborator category [1] 252180 0
Commercial sector/Industry
Name [1] 252180 0
Sport Taranaki
Address [1] 252180 0
Yarrow Stadium,
No 2 Field,
Maratahu Street,
New Plymouth 4310
Country [1] 252180 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269569 0
Ethics committee address [1] 269569 0
Ethics committee country [1] 269569 0
Date submitted for ethics approval [1] 269569 0
22/08/2011
Approval date [1] 269569 0
20/12/2011
Ethics approval number [1] 269569 0

Summary
Brief summary
There is a lack of clinical research looking at interventions for child and adolescent obesity with long-term follow-up, especially in New Zealand. This study aims to improve local obesity services for 5-16 year olds in the Taranaki region, and assess whether the devised intervention programme shows benefits in those participants that are assessed as ready to make healthy lifestyle changes. The intervention programme involves physical activity, dietary education, and psychology input. It will run for one year, but follow-up will be for two years. The benefits that are hoped to be found are improvement in health measures such as body mass index, weight, physical fitness and activity, improved diet, and improved attitude to making healthy lifestyle choices. It is important that this service is assessed through a trial to ensure the intervention is better than current standard of care, and to ensure long-term funding for the service.
Trial website
Nil
Trial related presentations / publications
Anderson YC, Wynter LE, Grant CC, Cave TL, Derraik JGB, Cutfield WS et al. (2017) A novel home-based intervention for child and adolescent obesity: the results of Whanau Pakari randomised controlled trial. Obesity 2017;25(11):1965-1973.

Anderson YC, Wynter, LE, Treves, KF, Grant CC, Stewart, JM, Cave TL, et al. (2016) Assessment of health-related quality of life and psychological well-being of children and adolescents with obesity enrolled in a New Zealand community-based intervention programme: an observational study. BMJ Open 2017;7:e015776. doi:10.1136/bmjopen-2016-015776

Anderson YC, Wynter LE, Grant CC, Stewart JM, Cave TL, Wild CEK, et al. (2016) Physical activity is low in obese New Zealand children and adolescents. Sci. Rep. 7:41822 doi: 10.1038/srep41822.

Anderson YC, Wynter LE, Butler MS, Grant CC, Stewart JM, Cave TL, et al. (2016) Dietary Intake and Eating Behaviours of Obese New Zealand Children and Adolescents Enrolled in a Community-Based Intervention Programme. PLOS ONE 11(11): e0166996. doi:10.1371/journal.pone.0166996

Anderson Y, Wynter L, Treves K, Grant C, Stewart J, Cave T, Wild C, Derraik J, Cutfield W, Hofman P. Prevalence of comorbidities in obese New Zealand children and adolescents at enrolment in a community-based obesity programme. Journal of Paediatrics & Child Health 2016; 52: 1099–1105 DOI:10.1111/jpc.13315

Anderson, Y. C., Wynter, L. E., Moller, K. R., Cave, T. L., Dolan, G. M. S., Grant, C. C., Stewart, J. M., Cutfield, W., S., Hofman, P. L. The effect of a multi-disciplinary obesity intervention compared to usual practice in those ready to make lifestyle changes: design and rationale of Whanau Pakari. BMC Obesity 2015, 2:41. http://www.biomedcentral.com/2052-9538/2/41

Public notes
Attachments [1] 21 21 0 0
/AnzctrAttachments/343300-HDEC_letter_-_CEN1109054_AM01_-_annual_progress_report[1].pdf

Contacts
Principal investigator
Name 32978 0
Dr Yvonne Anderson
Address 32978 0
Child and Adolescent Centre,
Taranaki Base Hospital,
David Street,
New Plymouth 4310
Country 32978 0
New Zealand
Phone 32978 0
+6467536139
Fax 32978 0
Email 32978 0
[email protected]
Contact person for public queries
Name 16225 0
Dr Yvonne Anderson
Address 16225 0
Child and Adolescent Centre,
David Street,
New Plymouth 4310
Country 16225 0
New Zealand
Phone 16225 0
00 64 6 7536139
Fax 16225 0
00 64 6 7537791
Email 16225 0
[email protected]
Contact person for scientific queries
Name 7153 0
Dr Yvonne Anderson
Address 7153 0
Child and Adolescent Centre,
David Street,
New Plymouth 4310
Country 7153 0
New Zealand
Phone 7153 0
00 64 6 7536139
Fax 7153 0
00 64 6 7537791
Email 7153 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

Current supporting documents:


Updated to:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
23196Study protocolAnderson, Y.C., Wynter, L.E., Moller, K.R. et al. The effect of a multi-disciplinary obesity intervention compared to usual practice in those ready to make lifestyle changes: design and rationale of Whanau Pakari. BMC Obes 2, 41 (2015). https://doi.org/10.1186/s40608-015-0068-yhttps://bmcobes.biomedcentral.com/articles/10.1186/s40608-015-0068-y[email protected] N/A 343300-(Uploaded-13-09-2020-13-59-00)-Study-related document.pdf

Results publications and other study-related documents

Documents added manually
Current Study Results
No documents have been uploaded by study researchers.

Update to Study Results
Doc. No.TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
3924Plain language summaryNo Objective: To determine whether 12-month BMI SDS r... [More Details]
4316Study results articleYes Anderson, YC, Wynter, LE, O'Sullivan, NA, et al. T... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseFive-year follow-up of a family-based multidisciplinary program for children with obesity.2021https://dx.doi.org/10.1002/oby.23225
EmbaseParticipants' and caregivers' experiences of a multidisciplinary programme for healthy lifestyle change in Aotearoa/New Zealand: A qualitative, focus group study.2021https://dx.doi.org/10.1136/bmjopen-2020-043516
EmbaseComparison of percentile tables and algorithm-based calculators for classification of blood pressures in children and adolescents with obesity: A secondary analysis of a clinical trial.2023https://dx.doi.org/10.1111/jpc.16270
EmbaseTwo-year outcomes of Whanau Pakari, a multi-disciplinary assessment and intervention for children and adolescents with weight issues: A randomized clinical trial.2021https://dx.doi.org/10.1111/ijpo.12693
EmbaseAssociations between changes in caregiver's and child's weight status in a community-based obesity intervention programme.2022https://dx.doi.org/10.1038/s41366-022-01121-3
EmbaseEconomic evaluation of a multi-disciplinary community-based intervention programme for New Zealand children and adolescents with obesity.2018https://dx.doi.org/10.1016/j.orcp.2018.04.001
EmbaseA Novel Home-Based Intervention for Child and Adolescent Obesity: The Results of the Whanau Pakari Randomized Controlled Trial.2017https://dx.doi.org/10.1002/oby.21967
EmbaseThe effect of a multi-disciplinary obesity intervention compared to usual practice in those ready to make lifestyle changes: Design and rationale of Whanau Pakari.2015https://dx.doi.org/10.1186/s40608-015-0068-y
N.B. These documents automatically identified may not have been verified by the study sponsor.