Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000692033
Ethics application status
Approved
Date submitted
19/08/2010
Date registered
20/08/2010
Date last updated
20/08/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluation of a after-school childhood obesity prevention program.
Scientific title
A non-randomised obesity prevention trial in children aged 5-12 years to evaluate the effectiveness of an after-school cooking club on child Body Mass Index (BMI).
Secondary ID [1] 252528 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Childhood obesity 258001 0
Condition category
Condition code
Diet and Nutrition 258168 258168 0 0
Obesity
Public Health 258169 258169 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A modified version of a previous weight management program known as the Hunter Illawarra Kids Challenge Using Parental Support (HIKCUPS) contextualised for a low socio-economic target group combined with a cooking club. The program is now named the Back to Basics Cooking Club and Healthy Lifestyle Program.

The intervention is based on Social Cognitive Theory that includes:
i) Five fortnightly, face-to-face group cooking sessions for children 90 minutes in duration over 3 months (one school term). The cooking sessions are facilitated by an experienced education professional.

ii) A group parent and child component facilitated by the investigator for the final 20minutes of each session. This component involves nutrition education and behavioural skills development for parents. Each parent will be encouraged to taste and discuss elements of the meal prepared by their child. Topics covered in this component include:

Benefits of healthy eating
Food label reading
Goal setting and monitoring
Intervention code [1] 257046 0
Prevention
Comparator / control treatment
Wait-list control arm. The subjects in the control group undertake baseline asessment but recieve no intervention for the first school term of the intervention. They return for re-assessment of the same baseline variables at the commencment of the second school term three months later. The wait-list control arm then become the active intervention arm described above. ie a cooking club for children combined with a parental component.
Control group
Active

Outcomes
Primary outcome [1] 259032 0
Change in body mass index (BMI) . BMI is calculated from height and weight (kg/m squared). Height is measured to 0.1 cm on a portable Holtain stadiometer. Weight is measured using calibrated digital scales that measure to 0.1 kg.
Timepoint [1] 259032 0
Baseline, 3 months, 6 months
Secondary outcome [1] 265269 0
Energy intake, measured by Food Frequency Questionnaire (FFQ)
Timepoint [1] 265269 0
Baseline, 3 months, 6 months
Secondary outcome [2] 265270 0
Child Fruit and Vegetable Self-efficacy by a developed Social Cognitive Theory (SCT) Questionnaire
Timepoint [2] 265270 0
Baseline, 3 months, 6 months
Secondary outcome [3] 265271 0
Child behavioural capabilities for fruit and vegetables by a developed Social Cognitive Theory (SCT) Questionnaire
Timepoint [3] 265271 0
Baseline, 3 months, 6 months
Secondary outcome [4] 265272 0
Child fruit and vegetable situation. By a developed Social Cognitive Theory (SCT) Questionnaire
Timepoint [4] 265272 0
Baseline, 3 months, 6 months
Secondary outcome [5] 265273 0
Child fruit and vegetable Outcome expectations by a developed Social Cognitive Theory (SCT) Questionnaire
Timepoint [5] 265273 0
Baseline, 3 months, 6 months
Secondary outcome [6] 265274 0
Child fruit and vegetable social environment by a developed Social Cognitive Theory (SCT) Questionnaire
Timepoint [6] 265274 0
Baseline, 3 months, 6 months

Eligibility
Key inclusion criteria
Children age 5-12 years attending a specific school in the Hunter Region and their parent/s.
Minimum age
5 Years
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
None.

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)
Once enrolled, subjects were allocated to treatment or wait-list control based on the following: child age, if siblings also participating in study or competing family committments effected participation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Non randomised.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
26/07/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
33
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 3153 0
2283

Funding & Sponsors
Funding source category [1] 257495 0
Charities/Societies/Foundations
Name [1] 257495 0
Newcastle Permenant Charitable Foundation
Country [1] 257495 0
Australia
Primary sponsor type
University
Name
University of Newcastle
Address
University Drive
Callaghan NSW
2308
Country
Australia
Secondary sponsor category [1] 256728 0
None
Name [1] 256728 0
Address [1] 256728 0
Country [1] 256728 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259522 0
University of Newcastle Human Research Ethics Committee
Ethics committee address [1] 259522 0
University Dr
Callaghan NSW 2308
Ethics committee country [1] 259522 0
Australia
Date submitted for ethics approval [1] 259522 0
Approval date [1] 259522 0
18/06/2010
Ethics approval number [1] 259522 0
H-2010-0017

Summary
Brief summary
Our project objective is to evaluate a program that will engage children and their parents to adopt positive behaviours relating to healthy eating. The intervention is a family focussed approach to be implemented in an after-school setting. We will evaluate its effectiveness as a childhood obesity prevention program for children.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31543 0
Address 31543 0
Country 31543 0
Phone 31543 0
Fax 31543 0
Email 31543 0
Contact person for public queries
Name 14790 0
Professor Clare Collins
Address 14790 0
HA12 Hunter Building
School of Health Sciences
University Drive
Callaghan NSW
2308
Country 14790 0
Australia
Phone 14790 0
+61 2 49215646
Fax 14790 0
Email 14790 0
[email protected]
Contact person for scientific queries
Name 5718 0
Professor Clare Collins
Address 5718 0
HA12 Hunter Building
School of Health Sciences
University Drive
Callaghan NSW
2308
Country 5718 0
Australia
Phone 5718 0
+61 2 49215646
Fax 5718 0
Email 5718 0
[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
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.