ANZCTR - Registration

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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]

Nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Obesity

Condition category

Condition code

Metabolic and Endocrine

Metabolic disorders

Diet and Nutrition

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]

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]

BMI reduction of 0.5SDS, as assessed by height and weight at 0, 6, 12, 18, 24 and 60 months.

Timepoint [1]

0, 6, 12, 18, 24 and 60 months

Primary outcome [2]

Improvement in quality of life (Paediatric QoL score)

Timepoint [2]

0, 12, 24 and 60 months

Primary outcome [3]

Improvement in physical activity (heart rate, accelerometer data, physical activity questionnaire)

Timepoint [3]

0, 6, 12, 18, 24 and 60 months

Secondary outcome [1]

Improvement in dietary behaviour (food frequency questionnaire)

Timepoint [1]

0, 6, 12, 18, 24 and 60 months

Secondary outcome [2]

Reduced sedentary activity (physical activity questionnaire)

Timepoint [2]

0, 6, 12, 18, 24 and 60 months

Secondary outcome [3]

Improved glycaemic control (HbA1c, fasting insulin, glucose, lipids)

Timepoint [3]

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?

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]

New Zealand

State/province [1]

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Taranaki Base Hospital

Address [1]

David Street,
New Plymouth 4310,
Taranaki

Country [1]

New Zealand

Primary sponsor type

Hospital

Name

Taranaki Base Hospital

Address

David Street,
New Plymouth 4310,
Taranaki

Country

New Zealand

Secondary sponsor category [1]

University

Name [1]

University of Auckland

Address [1]

Liggins Institute,
The University of Auckland,
Private Bag 92019,
Victoria Street West,
Auckland 1142

Country [1]

New Zealand

Other collaborator category [1]

Commercial sector/Industry

Name [1]

Sport Taranaki

Address [1]

Yarrow Stadium,
No 2 Field,
Maratahu Street,
New Plymouth 4310

Country [1]

New Zealand

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Ethics committee address [1]

Ethics committee country [1]

Date submitted for ethics approval [1]

22/08/2011

Approval date [1]

20/12/2011

Ethics approval number [1]

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]

/AnzctrAttachments/343300-HDEC_letter_-_CEN1109054_AM01_-_annual_progress_report[1].pdf

Contacts

Principal investigator

Name

Dr Yvonne Anderson

Address

Child and Adolescent Centre,
Taranaki Base Hospital,
David Street,
New Plymouth 4310

Country

New Zealand

Phone

+6467536139

Fax

[email protected]

Contact person for public queries

Name

Yvonne Anderson

Address

Child and Adolescent Centre,
David Street,
New Plymouth 4310

Country

New Zealand

Phone

00 64 6 7536139

Fax

00 64 6 7537791

[email protected]

Contact person for scientific queries

Name

Yvonne Anderson

Address

Child and Adolescent Centre,
David Street,
New Plymouth 4310

Country

New Zealand

Phone

00 64 6 7536139

Fax

00 64 6 7537791

[email protected]

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
Plain language summary	No		Objective: To determine whether 12-month BMI SDS r... [More Details]
Study results article	Yes		Anderson, YC, Wynter, LE, O'Sullivan, NA, et al. T... [More Details]

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	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.	2015	https://dx.doi.org/10.1186/s40608-015-0068-y
Embase	A Novel Home-Based Intervention for Child and Adolescent Obesity: The Results of the Whanau Pakari Randomized Controlled Trial.	2017	https://dx.doi.org/10.1002/oby.21967
Embase	Economic evaluation of a multi-disciplinary community-based intervention programme for New Zealand children and adolescents with obesity.	2018	https://dx.doi.org/10.1016/j.orcp.2018.04.001
Embase	Five-year follow-up of a family-based multidisciplinary program for children with obesity.	2021	https://dx.doi.org/10.1002/oby.23225
Embase	Participants' and caregivers' experiences of a multidisciplinary programme for healthy lifestyle change in Aotearoa/New Zealand: A qualitative, focus group study.	2021	https://dx.doi.org/10.1136/bmjopen-2020-043516
Embase	Two-year outcomes of Whanau Pakari, a multi-disciplinary assessment and intervention for children and adolescents with weight issues: A randomized clinical trial.	2021	https://dx.doi.org/10.1111/ijpo.12693
Embase	Associations between changes in caregiver's and child's weight status in a community-based obesity intervention programme.	2022	https://dx.doi.org/10.1038/s41366-022-01121-3
Embase	Comparison 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.	2023	https://dx.doi.org/10.1111/jpc.16270

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically